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53. Everolimus with Reduced Calcineurin Inhibitor Exposure in Renal Transplantation

Author

Pascual, J., Berger, S. P., Witzke, O., Tedesco, H., Mulgaonkar, S., Qazi, Y., Chadban, S., Oppenheimer, F., Sommerer, C., Oberbauer, R., Watarai, Y., Legendre, C., Citterio, F., Henry, M., Srinivas, T. R., Luo, W. -L., Marti, A., Bernhardt, P., Vincenti, F., Citterio F. (ORCID:0000-0003-0489-6337), Pascual, J., Berger, S. P., Witzke, O., Tedesco, H., Mulgaonkar, S., Qazi, Y., Chadban, S., Oppenheimer, F., Sommerer, C., Oberbauer, R., Watarai, Y., Legendre, C., Citterio, F., Henry, M., Srinivas, T. R., Luo, W. -L., Marti, A., Bernhardt, P., Vincenti, F., and Citterio F. (ORCID:0000-0003-0489-6337)

Abstract

Background Everolimus permits reduced calcineurin inhibitor (CNI) exposure, but the efficacy and safety outcomes of this treatment after kidney transplant require confirmation. Methods In a multicenter noninferiority trial, we randomized 2037 de novo kidney transplant recipients to receive, in combination with induction therapy and corticosteroids, everolimus with reduced-exposure CNI (everolimus arm) or mycophenolic acid (MPA) with standard-exposure CNI (MPA arm). The primary end point was treated biopsy-proven acute rejection or eGFR,50 ml/min per 1.73 m2 at post-transplant month 12 using a 10% noninferiority margin. Results In the intent-to-treat population (everolimus n=1022, MPA n=1015), the primary end point incidence was 48.2% (493) with everolimus and 45.1% (457) with MPA (difference 3.2%; 95% confidence interval, 21.3% to 7.6%). Similar between-treatment differences in incidence were observed in the subgroups of patients who received tacrolimus or cyclosporine. Treated biopsy-proven acute rejection, graft loss, or death at post-transplant month 12 occurred in 14.9% and 12.5% of patients treated with everolimus and MPA, respectively (difference 2.3%; 95% confidence interval, 21.7% to 6.4%). De novo donor-specific antibody incidence at 12 months and antibody-mediated rejection rate did not differ between arms. Cytomegalovirus (3.6% versus 13.3%) and BK virus infections (4.3% versus 8.0%) were less frequent in the everolimus arm than in the MPA arm. Overall, 23.0% and 11.9% of patients treated with everolimus and MPA, respectively, discontinued the study drug because of adverse events. Conclusions In kidney transplant recipients at mild-to-moderate immunologic risk, everolimus was noninferior to MPA for a binary composite end point assessing immunosuppressive efficacy and preservation of graft function.

Published
2018

55. Cinacalcet, fibroblast growth factor-23, and cardiovascular disease in hemodialysis: The evaluation of cinacalcet HCl therapy to lower cardiovascular events (EVOLVE) trial

Author

Moe S. M., Chertow G. M., Parfrey P. S., Kubo Y., Block G. A., Correa-Rotter R., Drueke T. B., Herzog C. A., London G. M., Mahaffey K. W., Wheeler D. C., Stolina M., Dehmel B., Goodman W. G., Floege J., Santos J., Najun Zarazaga C., Marin I., Garrote N., Cusumano A., Penalba N., Del Valle E., Juncos L., Martinez Saye J., Lef L., Altobelli V., Petraglia G., Rosa Diez G., Douthat W., Lobo J., Gallart C., Lafalla A., Diez G., Linares B., Lopez N., Ramirez N., Gonzalez R., Valtuille R., Beresan H., Hermida O., Rudolf G., Marchetta N., Rano M., Ramirez M., Garcia N., Gillies A., Jones B., Pedagogos E., Walker R., Talaulikar G., Bannister K., Suranyi M., Kark A., Roger S., Kerr P., Disney A., Mount P., Fraenkel M., Mathew M., Fassett R., Jose M., Hawley C., Lonergan M., Mackie J., Ferrari P., Menahem S., Sabto J., Hutchison B., Langham R., Pollock C., Holzer H., Oberbauer R., Arias I., Graf H., Mayer G., Lhotta K., Neyer U., Klauser R., Hoerl W., Horn S., Kovarik J., Kramar R., Eigner M., Dhaene M., Billiouw J., De Meester J., Warling X., Cambier-Dwelschauwers P., Evenepoel P., Daelemans R., Dratwa M., Maes B., Stolear J., Dejagere T., Vanwalleghem J., Bouman K., Jadoul M., Peeters J., Vanholder R., Tielemans C., Donck J., Almeida F., Picollo De Oliveira J., Burdmann E., Garcia V., Saldanha Thome F., Deboni L., Bregman R., Lugon J., Araujo S., Ferreira Filho S., De Francesco Daher E., Sperto Baptista M., Carvalho A., D'Avila D., Moyses Neto M., Yu L., Bastos M., Sampaio Lacativa P., Jorgetti V., De Almeida Romao E., Cardeal Da Costa J., Pecoits Filho R., Gordan P., Salgado N., Teixeira Araujo M., Neiva Coelho S., Oliveira I., Moyses R., Vasconcellos L., Batista P., Luiz Gross J., Pedrosa A., Cournoyer S., LeBlanc M., Chow S., Karunakaran S., Wong G., Tobe S., Desmeules S., Zimmerman D., Murphy S., Montambault P., Donnelly S., MacRae J., Culleton B., Soroka S., Rabbat C., Jindal K., Vasilevsky M., Michaud M., Wijeyesinghe E., Zacharias J., Lok C., Muirhead N., Verrelli M., Da Roza G., Sapir D., Olgaard K., Daugaard H., Brandi L., Jensen P., Boulechfar H., Ang K., Simon P., Rieu P., Brunet P., Touchard G., Urena Torres P., Combe C., Durrbach A., Ortiz J., Hannedouche T., Vela C., Lionet A., Ryckelynck P., Zaoui P., Choukroun G., Fessi H., Lang P., Stroumza P., Joly D., Mousson C., Laville M., Dellanna F., Erley C., Braun J., Rambausek M., Riegel W., Klingberg M., Schwertfeger E., Wizemann V., Eckardt K., Reichel H., Passauer J., Hubel E., Frischmuth N., Liebl R., Fiedler R., Schwenger V., Vosskuhler A., Kunzendorf U., Renders L., Rattensberger D., Rump L., Ketteler M., Neumayer H., Zantvoort F., Stahl R., Ladanyi E., Kulcsar I., Mezei I., Csiky B., Rikker C., Arkossy O., Berta K., Szegedi J., Major L., Ferenczi S., Fekete A., Szabo T., Zakar G., Wagner G., Kazup Erdelyine S., Borbas B., Eustace J., Reddan D., Capasso G., Locatelli F., Villa G., Cozzolino M., Brancaccio D., Messa P., Bolasco P., Ricciardi B., Malberti F., Moriero E., Cannella G., Ortalda V., Stefoni S., Frasca G., Cappelli G., Albertazzi A., Zoccali C., Farina M., Elli A., Avella F., Ondei P., Mingardi G., Errico R., Losito A., Di Giulio S., Pertosa G., Schena F., Grandaliano G., Gesualdo L., Auricchio M., Bochicchio-Ricardelli T., Aranda Verastegui F., Pena J., Chew Wong A., Cruz-Valdez J., Torres Zamora M., Solis M., Sebastian Diaz M., Vital Flores M., Alvarez Sandoval E., Van Den Dorpel M., Brink H., Van Kuijk W., Vermeij C., Smak Gregoor P., Hagen E., Van Der Sande F., Klinger M., Nowicki M., Muszytowski M., Bidas K., Bentkowski W., Wiecek A., Ksiazek A., Marczewski K., Ostrowski M., Switalski M., Sulowicz W., Matuszkiewicz-Rowinska J., Mysliwiec M., Durlik M., Rutkowski B., Macario F., Carvalho B., Frazao J., Machado D., Weigert A., Andrusev A., Khrustalev O., Zemtchenkov A., Gurevich K., Staroselsky K., Khadikova N., Rozhinskaya L., Timokhovskaya G., Strokov A., Balkarova O., Ermolenko V., Kolmakova E., Komandenko M., Timofeev M., Shilo V., Shostka G., Smirnov A., Anashkin V., Volgina G., Domashenko O., Gurevich A., Perlin D., Martinez Garcia J., Andres Ribes E., Coll Piera E., Fernandez Lucas M., Galicia M., Prados M., Gonzalez M., Romero R., Martin de Francisco A., Montenegro J., Santiago C., Garcia F., Alcazar De La Ossa J., Arrieta J., Pons J., Martin-Malo A., Soler Amigo J., Cases A., Sterner G., Jensen G., Wikstrom B., Jacobson S., Lund U., Weiss L., Stahl A., Von Albertini B., Burnier M., Meier P., Martin P., Uehlinger D., Dickenmann M., Yaqoob M., Zehnder D., Kalra P., Padmanabhan N., Roe S., Eadington D., Pritchard N., Hutchison A., Davies S., Wilkie M., Davies M., Pai P., Swift P., Kwan J., Goldsmith D., Tomson C., Stratton J., Dasgupta I., Sarkar S., Moustafa M., Gandhi K., Jamal A., Galindo-Ramos E., Tuazon J., Batlle D., Tucker K., Schiller-Moran B., Assefi A., Martinez C., Samuels L., Goldman J., Cangiano-Rivera J., Darwish R., Lee M., Topf J., Kapatkin K., Baer H., Kopelman R., Acharya M., Tharpe D., Bernardo M., Nader P., Guzman-Rivera J., Pergola P., Sekkarie M., Alas E., Zager P., Liss K., Navarro J., Roppolo M., Denu-Ciocca C., Kshirsagar A., El Khatib M., Kant K., Scott D., Murthyr B., Finkelstein F., Keightley G., McCrary R., Pitone J., Cavalieri T., Tsang A., Pellegrino B., Schmidt R., Ahmad S., Brown C., Friedman E., Mittman N., Fadem S., Shapiro W., Reddy M., Goldberger S., Woredekal Y., Agarwal A., Anger M., Haque M., Chidester P., Kohli R., Rubinstein S., Newman G., Gladish R., Ayodeji O., Soman S., Sprague S., Hunt N., Gehr T., Rizk D., Warnock D., Polack D., Pahl M., Fischer D., Dreyer P., James G., Husserl F., Rogers T., Raff A., Sedor J., Silver M., Smith M., Steinberg S., DelGiorno T., Jones E., Cunha P. D., Cheng J., Pogue V., Blumenthal S., Brown E., Charytan C., Buerkert J., Cook M., Felsenfeld A., Tareen N., Gupta A., Herman T., Diamond S., Hura C., Laski M., MacLaurin J., Plumb T., Brosnahan G., Kumar J., Henriquez M., Poole C., Osanloo E., Matalon A., Sholer C., Arfeen S., Azer M., Belledonne M., Gross M., Dunnigan E., McConnell K., Becker B., Skinner F., Rigolosi R., Spiegel D., Stegman M., Patak R., Streja D., Ranjit U., Youell T., Wooldridge T., Stafford C., Cottiero R., Weinberg M., Schonefeld M., Shahmir E., Hazzan A., Ashfaq A., Bhandari K., Cleveland W., Culpepper M., Golden J., Lai L., Lien Y., Lorica V., Robertson J., Malireddi K., Morse S., Thakur V., Israelit A., Raguram P., Alfred H., Weise W., Al-Saghir F., El Shahawy M., Rastogi A., Nissenson A., Kopyt N., Lynn R., Lea J., McClellan W., Teredesai P., Ong S., Tolkan S., Sugihara J., Minga T., Mehrotra R., Minasian R., Bhatia D., Specter R., Capelli J., Sidhu P., Dalal S., Dykes P., Khan M., Rahim F., Saklayen M., Thomas A., Michael B., Torres M., Al-Bander H., Murray B., Abukurah A., Gupta B., Nosrati S., Raja R., Zeig S., Braun M., Amatya A., Endsley J., Sharon Z., Dolson G., Dumler F., Ntoso K., Rosansky S., Kumar N., Gura V., Thompson N., Goldfarb D., Halligan R., Middleton J., Widerhorn A., Arbeit L., Arruda J., Crouch T., Friedman L., Khokhar S., Mittleman J., Light P., Taparia B., West C., Cotton J., Dhingra R., Kleinman L., Arif F., Lew S., Nammour T., Sterrett J., Williams M., Ramirez J., Rubin J., McCarthy J., Noble S., Chaffin M., Rekhi A., Moe, S. M., Chertow, G. M., Parfrey, P. S., Kubo, Y., Block, G. A., Correa-Rotter, R., Drueke, T. B., Herzog, C. A., London, G. M., Mahaffey, K. W., Wheeler, D. C., Stolina, M., Dehmel, B., Goodman, W. G., Floege, J., Santos, J., Najun Zarazaga, C., Marin, I., Garrote, N., Cusumano, A., Penalba, N., Del Valle, E., Juncos, L., Martinez Saye, J., Lef, L., Altobelli, V., Petraglia, G., Rosa Diez, G., Douthat, W., Lobo, J., Gallart, C., Lafalla, A., Diez, G., Linares, B., Lopez, N., Ramirez, N., Gonzalez, R., Valtuille, R., Beresan, H., Hermida, O., Rudolf, G., Marchetta, N., Rano, M., Ramirez, M., Garcia, N., Gillies, A., Jones, B., Pedagogos, E., Walker, R., Talaulikar, G., Bannister, K., Suranyi, M., Kark, A., Roger, S., Kerr, P., Disney, A., Mount, P., Fraenkel, M., Mathew, M., Fassett, R., Jose, M., Hawley, C., Lonergan, M., Mackie, J., Ferrari, P., Menahem, S., Sabto, J., Hutchison, B., Langham, R., Pollock, C., Holzer, H., Oberbauer, R., Arias, I., Graf, H., Mayer, G., Lhotta, K., Neyer, U., Klauser, R., Hoerl, W., Horn, S., Kovarik, J., Kramar, R., Eigner, M., Dhaene, M., Billiouw, J., De Meester, J., Warling, X., Cambier-Dwelschauwers, P., Evenepoel, P., Daelemans, R., Dratwa, M., Maes, B., Stolear, J., Dejagere, T., Vanwalleghem, J., Bouman, K., Jadoul, M., Peeters, J., Vanholder, R., Tielemans, C., Donck, J., Almeida, F., Picollo De Oliveira, J., Burdmann, E., Garcia, V., Saldanha Thome, F., Deboni, L., Bregman, R., Lugon, J., Araujo, S., Ferreira Filho, S., De Francesco Daher, E., Sperto Baptista, M., Carvalho, A., D'Avila, D., Moyses Neto, M., Yu, L., Bastos, M., Sampaio Lacativa, P., Jorgetti, V., De Almeida Romao, E., Cardeal Da Costa, J., Pecoits Filho, R., Gordan, P., Salgado, N., Teixeira Araujo, M., Neiva Coelho, S., Oliveira, I., Moyses, R., Vasconcellos, L., Batista, P., Luiz Gross, J., Pedrosa, A., Cournoyer, S., Leblanc, M., Chow, S., Karunakaran, S., Wong, G., Tobe, S., Desmeules, S., Zimmerman, D., Murphy, S., Montambault, P., Donnelly, S., Macrae, J., Culleton, B., Soroka, S., Rabbat, C., Jindal, K., Vasilevsky, M., Michaud, M., Wijeyesinghe, E., Zacharias, J., Lok, C., Muirhead, N., Verrelli, M., Da Roza, G., Sapir, D., Olgaard, K., Daugaard, H., Brandi, L., Jensen, P., Boulechfar, H., Ang, K., Simon, P., Rieu, P., Brunet, P., Touchard, G., Urena Torres, P., Combe, C., Durrbach, A., Ortiz, J., Hannedouche, T., Vela, C., Lionet, A., Ryckelynck, P., Zaoui, P., Choukroun, G., Fessi, H., Lang, P., Stroumza, P., Joly, D., Mousson, C., Laville, M., Dellanna, F., Erley, C., Braun, J., Rambausek, M., Riegel, W., Klingberg, M., Schwertfeger, E., Wizemann, V., Eckardt, K., Reichel, H., Passauer, J., Hubel, E., Frischmuth, N., Liebl, R., Fiedler, R., Schwenger, V., Vosskuhler, A., Kunzendorf, U., Renders, L., Rattensberger, D., Rump, L., Ketteler, M., Neumayer, H., Zantvoort, F., Stahl, R., Ladanyi, E., Kulcsar, I., Mezei, I., Csiky, B., Rikker, C., Arkossy, O., Berta, K., Szegedi, J., Major, L., Ferenczi, S., Fekete, A., Szabo, T., Zakar, G., Wagner, G., Kazup Erdelyine, S., Borbas, B., Eustace, J., Reddan, D., Capasso, G., Locatelli, F., Villa, G., Cozzolino, M., Brancaccio, D., Messa, P., Bolasco, P., Ricciardi, B., Malberti, F., Moriero, E., Cannella, G., Ortalda, V., Stefoni, S., Frasca, G., Cappelli, G., Albertazzi, A., Zoccali, C., Farina, M., Elli, A., Avella, F., Ondei, P., Mingardi, G., Errico, R., Losito, A., Di Giulio, S., Pertosa, G., Schena, F., Grandaliano, G., Gesualdo, L., Auricchio, M., Bochicchio-Ricardelli, T., Aranda Verastegui, F., Pena, J., Chew Wong, A., Cruz-Valdez, J., Torres Zamora, M., Solis, M., Sebastian Diaz, M., Vital Flores, M., Alvarez Sandoval, E., Van Den Dorpel, M., Brink, H., Van Kuijk, W., Vermeij, C., Smak Gregoor, P., Hagen, E., Van Der Sande, F., Klinger, M., Nowicki, M., Muszytowski, M., Bidas, K., Bentkowski, W., Wiecek, A., Ksiazek, A., Marczewski, K., Ostrowski, M., Switalski, M., Sulowicz, W., Matuszkiewicz-Rowinska, J., Mysliwiec, M., Durlik, M., Rutkowski, B., Macario, F., Carvalho, B., Frazao, J., Machado, D., Weigert, A., Andrusev, A., Khrustalev, O., Zemtchenkov, A., Gurevich, K., Staroselsky, K., Khadikova, N., Rozhinskaya, L., Timokhovskaya, G., Strokov, A., Balkarova, O., Ermolenko, V., Kolmakova, E., Komandenko, M., Timofeev, M., Shilo, V., Shostka, G., Smirnov, A., Anashkin, V., Volgina, G., Domashenko, O., Gurevich, A., Perlin, D., Martinez Garcia, J., Andres Ribes, E., Coll Piera, E., Fernandez Lucas, M., Galicia, M., Prados, M., Gonzalez, M., Romero, R., Martin de Francisco, A., Montenegro, J., Santiago, C., Garcia, F., Alcazar De La Ossa, J., Arrieta, J., Pons, J., Martin-Malo, A., Soler Amigo, J., Cases, A., Sterner, G., Jensen, G., Wikstrom, B., Jacobson, S., Lund, U., Weiss, L., Stahl, A., Von Albertini, B., Burnier, M., Meier, P., Martin, P., Uehlinger, D., Dickenmann, M., Yaqoob, M., Zehnder, D., Kalra, P., Padmanabhan, N., Roe, S., Eadington, D., Pritchard, N., Hutchison, A., Davies, S., Wilkie, M., Davies, M., Pai, P., Swift, P., Kwan, J., Goldsmith, D., Tomson, C., Stratton, J., Dasgupta, I., Sarkar, S., Moustafa, M., Gandhi, K., Jamal, A., Galindo-Ramos, E., Tuazon, J., Batlle, D., Tucker, K., Schiller-Moran, B., Assefi, A., Martinez, C., Samuels, L., Goldman, J., Cangiano-Rivera, J., Darwish, R., Lee, M., Topf, J., Kapatkin, K., Baer, H., Kopelman, R., Acharya, M., Tharpe, D., Bernardo, M., Nader, P., Guzman-Rivera, J., Pergola, P., Sekkarie, M., Alas, E., Zager, P., Liss, K., Navarro, J., Roppolo, M., Denu-Ciocca, C., Kshirsagar, A., El Khatib, M., Kant, K., Scott, D., Murthyr, B., Finkelstein, F., Keightley, G., Mccrary, R., Pitone, J., Cavalieri, T., Tsang, A., Pellegrino, B., Schmidt, R., Ahmad, S., Brown, C., Friedman, E., Mittman, N., Fadem, S., Shapiro, W., Reddy, M., Goldberger, S., Woredekal, Y., Agarwal, A., Anger, M., Haque, M., Chidester, P., Kohli, R., Rubinstein, S., Newman, G., Gladish, R., Ayodeji, O., Soman, S., Sprague, S., Hunt, N., Gehr, T., Rizk, D., Warnock, D., Polack, D., Pahl, M., Fischer, D., Dreyer, P., James, G., Husserl, F., Rogers, T., Raff, A., Sedor, J., Silver, M., Smith, M., Steinberg, S., Delgiorno, T., Jones, E., Cunha, P. D., Cheng, J., Pogue, V., Blumenthal, S., Brown, E., Charytan, C., Buerkert, J., Cook, M., Felsenfeld, A., Tareen, N., Gupta, A., Herman, T., Diamond, S., Hura, C., Laski, M., Maclaurin, J., Plumb, T., Brosnahan, G., Kumar, J., Henriquez, M., Poole, C., Osanloo, E., Matalon, A., Sholer, C., Arfeen, S., Azer, M., Belledonne, M., Gross, M., Dunnigan, E., Mcconnell, K., Becker, B., Skinner, F., Rigolosi, R., Spiegel, D., Stegman, M., Patak, R., Streja, D., Ranjit, U., Youell, T., Wooldridge, T., Stafford, C., Cottiero, R., Weinberg, M., Schonefeld, M., Shahmir, E., Hazzan, A., Ashfaq, A., Bhandari, K., Cleveland, W., Culpepper, M., Golden, J., Lai, L., Lien, Y., Lorica, V., Robertson, J., Malireddi, K., Morse, S., Thakur, V., Israelit, A., Raguram, P., Alfred, H., Weise, W., Al-Saghir, F., El Shahawy, M., Rastogi, A., Nissenson, A., Kopyt, N., Lynn, R., Lea, J., Mcclellan, W., Teredesai, P., Ong, S., Tolkan, S., Sugihara, J., Minga, T., Mehrotra, R., Minasian, R., Bhatia, D., Specter, R., Capelli, J., Sidhu, P., Dalal, S., Dykes, P., Khan, M., Rahim, F., Saklayen, M., Thomas, A., Michael, B., Torres, M., Al-Bander, H., Murray, B., Abukurah, A., Gupta, B., Nosrati, S., Raja, R., Zeig, S., Braun, M., Amatya, A., Endsley, J., Sharon, Z., Dolson, G., Dumler, F., Ntoso, K., Rosansky, S., Kumar, N., Gura, V., Thompson, N., Goldfarb, D., Halligan, R., Middleton, J., Widerhorn, A., Arbeit, L., Arruda, J., Crouch, T., Friedman, L., Khokhar, S., Mittleman, J., Light, P., Taparia, B., West, C., Cotton, J., Dhingra, R., Kleinman, L., Arif, F., Lew, S., Nammour, T., Sterrett, J., Williams, M., Ramirez, J., Rubin, J., Mccarthy, J., Noble, S., Chaffin, M., Rekhi, A., and Clinical sciences

Subjects
Adult, Male, Fibroblast growth factor 23, medicine.medical_specialty, Cinacalcet, Calcimimetic, medicine.medical_treatment, Naphthalenes, Hyperthyroidism, Gastroenterology, ventricular remodeling, Renal Dialysis, Cinacalcet Hydrochloride, Physiology (medical), Internal medicine, medicine, Humans, renal insufficiency, chronic, Aged, Etelcalcetide, calcium, business.industry, Research Support, Non-U.S. Gov't, death, sudden, cardiac, Middle Aged, arrhythmias, cardiac, Cardiovascular Diseases, Female, Fibroblast Growth Factors, Cardiology and Cardiovascular Medicine, medicine.disease, Fibroblast Growth Factor-23, Endocrinology, Randomized Controlled Trial, Secondary hyperparathyroidism, Hemodialysis, business, medicine.drug, Kidney disease
Abstract

Background— Patients with kidney disease have disordered bone and mineral metabolism, including elevated serum concentrations of fibroblast growth factor-23 (FGF23). These elevated concentrations are associated with cardiovascular and all-cause mortality. The objective was to determine the effects of the calcimimetic cinacalcet (versus placebo) on reducing serum FGF23 and whether changes in FGF23 are associated with death and cardiovascular events. Methods and Results— This was a secondary analysis of a randomized clinical trial comparing cinacalcet to placebo in addition to conventional therapy (phosphate binders/vitamin D) in patients receiving hemodialysis with secondary hyperparathyroidism (intact parathyroid hormone ≥300 pg/mL). The primary study end point was time to death or a first nonfatal cardiovascular event (myocardial infarction, hospitalization for angina, heart failure, or a peripheral vascular event). This analysis included 2985 patients (77% of randomized) with serum samples at baseline and 2602 patients (67%) with samples at both baseline and week 20. The results demonstrated that a significantly larger proportion of patients randomized to cinacalcet had ≥30% (68% versus 28%) reductions in FGF23. Among patients randomized to cinacalcet, a ≥30% reduction in FGF23 between baseline and week 20 was associated with a nominally significant reduction in the primary composite end point (relative hazard, 0.82; 95% confidence interval, 0.69–0.98), cardiovascular mortality (relative hazard, 0.66; 95% confidence interval, 0.50–0.87), sudden cardiac death (relative hazard, 0.57; 95% confidence interval, 0.37–0.86), and heart failure (relative hazard, 0.69; 95% confidence interval, 0.48–0.99). Conclusions— Treatment with cinacalcet significantly lowers serum FGF23. Treatment-induced reductions in serum FGF23 are associated with lower rates of cardiovascular death and major cardiovascular events. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT00345839.

Published
2015

60. Early Conversion From Calcineurin Inhibitor- to Everolimus-Based Therapy Following Kidney Transplantation: Results of the Randomized ELEVATE Trial

Author

de Fijter, J. W., Holdaas, H., Oyen, O., Sanders, J. -S., Sundar, S., Bemelman, F. J., Sommerer, C., Pascual, J., Avihingsanon, Y., Pongskul, C., Oppenheimer, F., Toselli, L., Russ, G., Wang, Z., Lopez, P., Kochuparampil, J., Cruzado, J. M., van der Giet, M., Gaite, L. E., Lopez, V. F., Maldonado, R., Massari, P., Novoa, P., Palti, G., Chadban, S., Kanellis, J., Masterson, R., Oberbauer, R., Saemann, M., Kuypers, D., Lohmus, A., Cassuto, E., Frimat, L., Lebranchu, Y., Le Meur, Y., Rostaing, L., Hauser, A., Muehlfeld, A., Nashan, B., Suwelack, B., Weithofer, P., Witzke, O., Zeier, M., Apostolou, T., Boletis, I., Gourmenos, D., Jasuja, S., Khullar, D., Ravishankar, M. S., Sharma, R. K., Garosi, G., Rigotti, P., Tisone, G., Todeschini, P., Acevedo, R., Rozentais, R., Juarez, F. J., Mier, G. M., Urrea, M., Machado, D., Nolasco, F., Sampaio, S., Dubanova, A., Lucan, M., Kolsanov, A. V., Medvedev, V. L., Moysyuk, Y. G., Nesterenko, V., Perlin, D. V., Ulyankina, I. V., Zagainov, E., Dalmau, A., Hernandez, D., Millan, S., Avhingsanon, Y., Turkmen, A., Tuncer, M., Yildiz, A., DIPARTIMENTO DI MEDICINA SPECIALISTICA, DIAGNOSTICA E SPERIMENTALE, Facolta' di MEDICINA e CHIRURGIA, Kuypers, Dirk, AII - Inflammatory diseases, Nephrology, AII - Amsterdam institute for Infection and Immunity, Groningen Kidney Center (GKC), and Groningen Institute for Organ Transplantation (GIOT)

Subjects
Graft Rejection, Male, HLA ANTIBODIES, immunosuppressant, kidney transplantation/nephrology, ELEVATE study, SIROLIMUS, immunosuppression/immune modulation, 030204 cardiovascular system & hematology, 030230 surgery, Pharmacology, Kidney Function Tests, Kidney Failure, 0302 clinical medicine, Postoperative Complications, cardiovascular disease, Risk Factors, Clinical endpoint, Immunology and Allergy, DONOR-SPECIFIC ANTIBODIES, Pharmacology (medical), Chronic, CARDIAC-HYPERTROPHY, Kidney transplantation, calcineurin inhibitor (CNI), clinical research/practice, clinical trial, kidney (allograft) function/dysfunction, mechanistic target of rapamycin: everolimus, Everolimus, Female, Follow-Up Studies, Glomerular Filtration Rate, Graft Survival, Humans, Immunosuppressive Agents, Kidney Failure, Chronic, Kidney Transplantation, Middle Aged, Prognosis, Tacrolimus, RENAL-TRANSPLANTATION, Kidney transplant, ELEVATE study, Certican, Life Sciences & Biomedicine, medicine.drug, medicine.medical_specialty, Certican, Urology, Renal function, Mycophenolic acid, 03 medical and health sciences, LEFT-VENTRICULAR MASS, PRESSURE-OVERLOAD, medicine, Kidney transplant, Transplantation, Science & Technology, business.industry, medicine.disease, Settore MED/18, Calcineurin, RECIPIENTS, MAMMALIAN TARGET, Sirolimus, CYCLOSPORINE, Surgery, business
Abstract

none 24 si In a 24-month, multicenter, open-label, randomized trial, 715 de novo kidney transplant recipients were randomized at 10-14 weeks to convert to everolimus (n = 359) or remain on standard calcineurin inhibitor (CNI) therapy (n = 356; 231 tacrolimus; 125 cyclosporine), all with mycophenolic acid and steroids. The primary endpoint, change in estimated glomerular filtration rate (eGFR) from randomization to month 12, was similar for everolimus versus CNI: mean (standard error) 0.3(1.5) mL/min/1.732 versus -1.5(1.5) mL/min/1.732 (p = 0.116). Biopsy-proven acute rejection (BPAR) at month 12 was more frequent under everolimus versus CNI overall (9.7% vs. 4.8%, p = 0.014) and versus tacrolimus-treated patients (2.6%, p < 0.001) but similar to cyclosporine-treated patients (8.8%, p = 0.755). Reporting on de novo donor-specific antibodies (DSA) was limited but suggested more frequent anti-HLA Class I DSA under everolimus. Change in left ventricular mass index was similar. Discontinuation due to adverse events was more frequent with everolimus (23.6%) versus CNI (8.4%). In conclusion, conversion to everolimus at 10-14 weeks posttransplant was associated with renal function similar to that with standard therapy overall. Rates of BPAR were low in all groups, but lower with tacrolimus than everolimus open de Fijter JW, Holdaas H, Øyen O, Sanders JS, Sundar S, Bemelman FJ, Sommerer C, Pascual J, Avihingsanon Y, Pongskul C, Oppenheimer F, Toselli L, Russ G, Wang Z, Lopez P, Kochuparampil J, Cruzado JM, van der Giet M; ELEVATE Study Group: [...; Guido Garosi; Paolo Rigotti; Giuseppe Tisone; Paola Todeschini; ...] de Fijter JW, Holdaas H, Øyen O, Sanders JS, Sundar S, Bemelman FJ, Sommerer C, Pascual J, Avihingsanon Y, Pongskul C, Oppenheimer F, Toselli L, Russ G, Wang Z, Lopez P, Kochuparampil J, Cruzado JM, van der Giet M; ELEVATE Study Group: [..; Guido Garosi; Paolo Rigotti; Giuseppe Tisone; Paola Todeschini; ..]

Published
2017

62. Surgical complications in ABOi kidney transplantation

Author

Rösch, CS, Schwierz, T, Krause, A, Enkner, W, Langer, R, Oberbauer, R, and Függer, R

Subjects
ddc: 610, 610 Medical sciences, Medicine
Abstract

Background: ABOi kidney transplantation is an increasingly applied strategy to increase donor pools in living donation. However, data on perioperative surgical complications are rare and suggest an increased complication rate. Materials and methods: 19 consecutive ABOi kidney transplantations were[for full text, please go to the a.m. URL], 133. Kongress der Deutschen Gesellschaft für Chirurgie

Published
2016
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65. Infants Requiring Maintenance Dialysis: Outcomes of Hemodialysis and Peritoneal Dialysis

Author

Vidal, Enrico, primary, van Stralen, Karlijn J., additional, Chesnaye, Nicholas C., additional, Bonthuis, Marjolein, additional, Holmberg, Christer, additional, Zurowska, Aleksandra, additional, Trivelli, Antonella, additional, Da Silva, José Eduardo Esteves, additional, Herthelius, Maria, additional, Adams, Brigitte, additional, Bjerre, Anna, additional, Jankauskiene, Augustina, additional, Miteva, Polina, additional, Emirova, Khadizha, additional, Bayazit, Aysun K., additional, Mache, Christoph J., additional, Sánchez-Moreno, Ana, additional, Harambat, Jérôme, additional, Groothoff, Jaap W., additional, Jager, Kitty J., additional, Schaefer, Franz, additional, Verrina, Enrico, additional, Shtiza, D., additional, Kramar, R., additional, Oberbauer, R., additional, Baiko, S., additional, Sukalo, A., additional, van Hoeck, K., additional, Collart, F., additional, des Grottes, J.M., additional, Pokrajac, D., additional, Roussinov, D., additional, Batinić, D., additional, Lemac, M., additional, Slavicek, J., additional, Seeman, T., additional, Vondrak, K., additional, Heaf, J.G., additional, Toots, U., additional, Finne, P., additional, Grönhagen-Riska, C., additional, Couchoud, C., additional, Lasalle, M., additional, Sahpazova, E., additional, Abazi, N., additional, Ristoka Bojkovska, N., additional, von Gersdorff, G., additional, Scholz, C., additional, Tönshoff, B., additional, Krupka, K., additional, Höcker, B., additional, Pape, L., additional, Afentakis, N., additional, Kapogiannis, A., additional, Printza, N., additional, Reusz, G., additional, Berecki, C.S., additional, Szabó, A., additional, Szabó, T., additional, Györke, Z.S., additional, Kis, E., additional, Palsson, R., additional, Edvardsson, V., additional, Gianoglio, B., additional, Maringhini, S., additional, Pecoraro, C., additional, Picca, S., additional, Testa, S., additional, Rudaitis, S., additional, Said-Conti, V., additional, Gatcan, S., additional, Berbeca, O., additional, Zaikova, N., additional, Pavićević, S., additional, Leivestad, T., additional, Zagozdzon, I., additional, Mota, C., additional, Almeida, M., additional, Afonso, C., additional, Mircescu, G., additional, Garneata, L., additional, Molchanova, E.A., additional, Tomilina, N.A., additional, Bikbov, B.T., additional, Kostic, M., additional, Peco-Antic, A., additional, Spasojevic-Dimitrijeva, B., additional, Milosevski-Lomic, G., additional, Paripovic, D., additional, Puric, S., additional, Kruscic, D., additional, Podracka, L., additional, Kolvek, G., additional, Buturovic-Ponikvar, J., additional, Novljan, G., additional, Battelino, N., additional, Alonso Melgar, A., additional, Schön, S., additional, Prütz, K.G., additional, Backmän, L., additional, Stendahl, M., additional, Evans, M., additional, Rippe, B., additional, Kuenhi, C.E., additional, Maurer, E., additional, Laube, G.F., additional, Tschumi, S., additional, Parvex, P., additional, Hoitsma, A., additional, Hemke, A., additional, Topaloglu, R., additional, Ivanov, D., additional, Pruthi, R., additional, Braddon, F., additional, Mannings, S., additional, Cassula, A., additional, and Sinha, M.D., additional

Published
2017
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66. Diet and kidney disease in high-risk individuals with type 2 diabetes mellitus

Author

Dunkler D, Dehghan M, Teo KK, Heinze G, Gao P, Kohl M, Clase CM, Mann JF, Yusuf S, Oberbauer R, ONTARGET Investigators, GIUGLIANO, Dario, Dunkler, D, Dehghan, M, Teo, Kk, Heinze, G, Gao, P, Kohl, M, Clase, Cm, Mann, Jf, Yusuf, S, Oberbauer, R, Giugliano, Dario, and Ontarget, Investigators

Published
2013

68. Developing Consensus-Based Priority Outcome Domains for Trials in Kidney Transplantation: A Multinational Delphi Survey with Patients, Caregivers, and Health Professionals.

Author

Shen J.I., Marson L., Josephson M.A., Reese P.P., Pruett T.L., Hanson C.S., O'Donoghue D., Tam-Tham H., Halimi J.-M., Kanellis J., Craig J.C., Rajan T., Chadban S., McDonald S.P., Mandayam S., Knight S., Jesudason S., Fung S., Oberbauer R., Masson P., Evangelidis N., Cross N., Howell M., Howard K., Scandling J.D., Sautenet B., Tong A., Manera K.E., Chapman J.R., Warrens A.N., Rosenbloom D., Wong G., Gill J., Budde K., Rostaing L., Shen J.I., Marson L., Josephson M.A., Reese P.P., Pruett T.L., Hanson C.S., O'Donoghue D., Tam-Tham H., Halimi J.-M., Kanellis J., Craig J.C., Rajan T., Chadban S., McDonald S.P., Mandayam S., Knight S., Jesudason S., Fung S., Oberbauer R., Masson P., Evangelidis N., Cross N., Howell M., Howard K., Scandling J.D., Sautenet B., Tong A., Manera K.E., Chapman J.R., Warrens A.N., Rosenbloom D., Wong G., Gill J., Budde K., and Rostaing L.

Abstract

Background Inconsistencies in outcome reporting and frequent omission of patient-centered outcomes can diminish the value of trials in treatment decision making. We identified critically important outcome domains in kidney transplantation based on the shared priorities of patients/caregivers and health professionals. Methods In a 3-round Delphi survey, patients/caregivers and health professionals rated the importance of outcome domains for trials in kidney transplantation on a 9-point Likert scale and provided comments. During rounds 2 and 3, participants rerated the outcomes after reviewing their own score, the distribution of the respondents' scores, and comments. We calculated the median, mean, and proportion rating 7 to 9 (critically important), and analyzed comments thematically. Results One thousand eighteen participants (461 [45%] patients/caregivers and 557 [55%] health professionals) from 79 countries completed round 1, and 779 (77%) completed round 3. The top 8 outcomes that met the consensus criteria in round 3 (mean, >=7.5; median, >=8; proportion, >85%) in both groups were graft loss, graft function, chronic rejection, acute rejection, mortality, infection, cancer (excluding skin), and cardiovascular disease. Compared with health professionals, patients/caregivers gave higher priority to 6 outcomes (mean difference of 0.5 or more): Skin cancer, surgical complications, cognition, blood pressure, depression, and ability to work. We identified 5 themes: Capacity to control and inevitability, personal relevance, debilitating repercussions, gaining awareness of risks, and addressing knowledge gaps. Conclusions Graft complications and severe comorbidities were critically important for both stakeholder groups. These stakeholder-prioritized outcomes will inform the core outcome set to improve the consistency and relevance of trials in kidney transplantation.Copyright © 2017 Wolters Kluwer Health, Inc.

Published
2017

69. Developing consensus-based priority outcome domains for trials in kidney transplantation: A multinational delphi survey with patients, caregivers and health professionals.

Author

Evangelidis N., Howard K., Howell M., Cross N., Masson P., Oberbauer R., Fung S., Jesudason S., Knight S., Mandayam S., Mcdonald S., Chadban S., Rajan T., Craig J., Sautenet B., Tong A., Manera K., Chapman J., Warrens A., Rosenbloom D., Wong G., Gill J., Budde K., Rostaing L., Marson L., Josephson M., Reese P., Pruett T., Hanson C., O'Donoghue D., Tam-Tham H., Halimi J.-M., Shen J., Kanellis J., Scandling J., Evangelidis N., Howard K., Howell M., Cross N., Masson P., Oberbauer R., Fung S., Jesudason S., Knight S., Mandayam S., Mcdonald S., Chadban S., Rajan T., Craig J., Sautenet B., Tong A., Manera K., Chapman J., Warrens A., Rosenbloom D., Wong G., Gill J., Budde K., Rostaing L., Marson L., Josephson M., Reese P., Pruett T., Hanson C., O'Donoghue D., Tam-Tham H., Halimi J.-M., Shen J., Kanellis J., and Scandling J.

Abstract

Background: Inconsistencies in outcome reporting and frequent omission of patient-centered outcomes can diminish the value of trials in treatment decision-making. We identified critically important outcome domains in kidney transplantation based on the shared priorities of patients/caregivers and health professionals. Method(s): In a 3-round Delphi survey, patients/caregivers and health professionals rated the importance of outcome domains for trials in kidney transplantation on a 9-point Likert scale and provided comments. During Round 2 and 3, participants re-rated the outcomes after reviewing their own score, the distribution of the respondents' scores, and comments. We calculated the median, mean, and proportion rating 7-9 (critically important), and analyzed comments thematically. Result(s): 1018 participants (461 [45%] patients/caregivers and 557 [55%] health professionals) from 79 countries completed Round 1, and 779 (77%) completed Round 3. The top eight outcomes that met the consensus criteria in Round 3 (mean >=7.5, median >=8 and proportion >85%) in both groups were graft loss, graft function, chronic rejection, acute rejection, mortality, infection, cancer (excluding skin) and cardiovascular disease. Compared with health professionals, patients/caregivers gave higher priority to six outcomes (mean difference of 0.5 or more): skin cancer, surgical complications, cognition, blood pressure, depression, and ability to work. We identified five themes: capacity to control and inevitability, personal relevance, debilitating repercussions, gaining awareness of risks, and addressing knowledge gaps. Discussion(s): Graft complications and severe comorbidities were critically important for both stakeholder groups. The stakeholder-prioritized outcomes will inform the core outcome set to improve the consistency and relevance of trials in kidney transplantation.

Published
2017

72. The DESCARTES-Nantes survey of kidney transplant recipients displaying clinical operational tolerance identifies 35 new tolerant patients and 34 almost tolerant patients

Author

Massart, A., Pallier, A., Pascual, J., Viklicky, O., Budde, K., Spasovski, G., Klinger, M., Sever, M.S., Sorensen, S.S., Hadaya, K., Oberbauer, R., Dudley, C., Fijter, J.W. de, Yussim, A., Hazzan, M., Wekerle, T., Berglund, D., Biase, C. De, Perez-Saez, M.J., Muhlfeld, A., Orlando, G., Clemente, K., Lai, Q., Pisani, F., Kandus, A., Baas, M.C., Bemelman, F., Ponikvar, J.B., Mazouz, H., Stratta, P., Subra, J.F., Villemain, F., Hoitsma, A., Braun, L., Cantarell, M.C., Colak, H., Courtney, A., Frasca, G.M., Howse, M., Naesens, M., Reischig, T., Seron, D., Seyahi, N., Tugmen, C., Hernandez, A., Bena, L., Biancone, L., Cuna, V., Diaz-Corte, C., Dufay, A., Gaasbeek, A., Garnier, A., Gatault, P., Gentil Govantes, M.A., Glowacki, F., Gross, O., Hurault de Ligny, B., Huynh-Do, U., Janbon, B., Jimenez Del Cerro, L.A., Keller, F., Manna, G. La, Lauzurica, R., Monies De Sagazan, H. Le, Thaiss, F., Legendre, C., Martin, S., Moal, M.C., Noel, C., Pillebout, E., Piredda, G.B., Puga, A.R., Sulowicz, W., Tuglular, S., Prokopova, M., Chesneau, M., Moine, A. Le, Guerif, P., Soulillou, J.P., Abramowicz, M., Giral, M., Racape, J., Maggiore, U., Brouard, S., Abramowicz, D., Massart, A., Pallier, A., Pascual, J., Viklicky, O., Budde, K., Spasovski, G., Klinger, M., Sever, M.S., Sorensen, S.S., Hadaya, K., Oberbauer, R., Dudley, C., Fijter, J.W. de, Yussim, A., Hazzan, M., Wekerle, T., Berglund, D., Biase, C. De, Perez-Saez, M.J., Muhlfeld, A., Orlando, G., Clemente, K., Lai, Q., Pisani, F., Kandus, A., Baas, M.C., Bemelman, F., Ponikvar, J.B., Mazouz, H., Stratta, P., Subra, J.F., Villemain, F., Hoitsma, A., Braun, L., Cantarell, M.C., Colak, H., Courtney, A., Frasca, G.M., Howse, M., Naesens, M., Reischig, T., Seron, D., Seyahi, N., Tugmen, C., Hernandez, A., Bena, L., Biancone, L., Cuna, V., Diaz-Corte, C., Dufay, A., Gaasbeek, A., Garnier, A., Gatault, P., Gentil Govantes, M.A., Glowacki, F., Gross, O., Hurault de Ligny, B., Huynh-Do, U., Janbon, B., Jimenez Del Cerro, L.A., Keller, F., Manna, G. La, Lauzurica, R., Monies De Sagazan, H. Le, Thaiss, F., Legendre, C., Martin, S., Moal, M.C., Noel, C., Pillebout, E., Piredda, G.B., Puga, A.R., Sulowicz, W., Tuglular, S., Prokopova, M., Chesneau, M., Moine, A. Le, Guerif, P., Soulillou, J.P., Abramowicz, M., Giral, M., Racape, J., Maggiore, U., Brouard, S., and Abramowicz, D.

Abstract

Item does not contain fulltext, BACKGROUND: Kidney recipients maintaining a prolonged allograft survival in the absence of immunosuppressive drugs and without evidence of rejection are supposed to be exceptional. The ERA-EDTA-DESCARTES working group together with Nantes University launched a European-wide survey to identify new patients, describe them and estimate their frequency for the first time. METHODS: Seventeen coordinators distributed a questionnaire in 256 transplant centres and 28 countries in order to report as many 'operationally tolerant' patients (TOL; defined as having a serum creatinine <1.7 mg/dL and proteinuria <1 g/day or g/g creatinine despite at least 1 year without any immunosuppressive drug) and 'almost tolerant' patients (minimally immunosuppressed patients (MIS) receiving low-dose steroids) as possible. We reported their number and the total number of kidney transplants performed at each centre to calculate their frequency. RESULTS: One hundred and forty-seven questionnaires were returned and we identified 66 TOL (61 with complete data) and 34 MIS patients. Of the 61 TOL patients, 26 were previously described by the Nantes group and 35 new patients are presented here. Most of them were noncompliant patients. At data collection, 31/35 patients were alive and 22/31 still operationally tolerant. For the remaining 9/31, 2 were restarted on immunosuppressive drugs and 7 had rising creatinine of whom 3 resumed dialysis. Considering all patients, 10-year death-censored graft survival post-immunosuppression weaning reached 85% in TOL patients and 100% in MIS patients. With 218 913 kidney recipients surveyed, cumulative incidences of operational tolerance and almost tolerance were estimated at 3 and 1.5 per 10 000 kidney recipients, respectively. CONCLUSIONS: In kidney transplantation, operational tolerance and almost tolerance are infrequent findings associated with excellent long-term death-censored graft survival.

Published
2016

73. Kidney Versus Combined Kidney and Liver Transplantation in Young People With Autosomal Recessive Polycystic Kidney Disease: Data From the European Society for Pediatric Nephrology/European Renal Association−European Dialysis and Transplant (ESPN/ERA-EDTA) Registry

Author

Mekahli, Djalila, primary, van Stralen, Karlijn J., additional, Bonthuis, Marjolein, additional, Jager, Kitty J., additional, Balat, Ayşe, additional, Benetti, Elisa, additional, Godefroid, Nathalie, additional, Edvardsson, Vidar O., additional, Heaf, James G., additional, Jankauskiene, Augustina, additional, Kerecuk, Larissa, additional, Marinova, Svetlana, additional, Puteo, Flora, additional, Seeman, Tomas, additional, Zurowska, Aleksandra, additional, Pirenne, Jacques, additional, Schaefer, Franz, additional, Groothoff, Jaap W., additional, Levtchenko, E., additional, Haffner, D., additional, Bjerre, A., additional, Massy, Z., additional, Shtiza, D., additional, Kramar, R., additional, Oberbauer, R., additional, Baiko, S., additional, Sukalo, A., additional, van Hoeck, K., additional, Collart, F., additional, des Grottes, J.M., additional, Pokrajac, D., additional, Roussinov, D., additional, Batinić, D., additional, Lemac, M., additional, Slavicek, J., additional, Seeman, T., additional, Vondrak, K., additional, Heaf, J.G., additional, Toots, U., additional, Finne, P., additional, Grönhagen-Riska, C., additional, Couchoud, C., additional, Lasalle, M, additional, Sahpazova, E, additional, Abazi, N, additional, Ristoka Bojkovska, N, additional, von Gersdorff, G, additional, Scholz, C, additional, Tönshoff, B, additional, Krupka, K, additional, Höcker, B, additional, Pape, L, additional, Afentakis, N, additional, Kapogiannis, A, additional, Printza, N, additional, Reusz, G, additional, Berecki, Cs, additional, Szabó, A, additional, Szabó, T, additional, Györke, Z.S., additional, Kis, E., additional, Palsson, R., additional, Edvardsson, V., additional, Gianoglio, B., additional, Maringhini, S., additional, Pecoraro, C., additional, Picca, S., additional, Testa, S., additional, Vidal, E., additional, Verrina, E., additional, Jankauskiene, A., additional, Pundziene, B., additional, Said-Conti, V., additional, Gatcan, S., additional, Berbeca, O., additional, Zaikova, N., additional, Pavićević, S., additional, Leivestad, T., additional, Zurowska, A., additional, Zagozdzon, I., additional, Mota, C., additional, Almeida, M., additional, Afonso, C., additional, Mircescu, G., additional, Garneata, L., additional, Molchanova, E.A., additional, Tomilina, N.A., additional, Bikbov, B.T., additional, Kostic, M., additional, Peco-Antic, A., additional, Spasojevic-Dimitrijeva, B., additional, Milosevski-Lomic, G., additional, Paripovic, D., additional, Puric, S., additional, Kruscic, D., additional, Podracka, L., additional, Kolvek, G., additional, Buturovic-Ponikvar, J., additional, Novljan, G., additional, Battelino, N., additional, Alonso Melgar, A., additional, Schön, S., additional, Prütz, K.G., additional, Backmän, L., additional, Stendahl, M., additional, Evans, M., additional, Rippe, B., additional, Kuenhi, C.E., additional, Maurer, E., additional, Laube, G.F., additional, Tschumi, S., additional, Parvex, P., additional, Hoitsma, A., additional, Hemke, A., additional, Topaloglu, R., additional, Duzova, A., additional, Ivanov, D., additional, Pruthi, R., additional, Braddon, F., additional, Mannings, S., additional, Cassula, A., additional, and Sinha, M.D., additional

Published
2016
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74. Introducing the Wiley Transplant Peer Review Network

Author

Kirk, A.D., primary, Malchesky, P.S., additional, Shapiro, R., additional, Webber, S.A., additional, Hirsch, H.H., additional, Marty, F.M., additional, Oberbauer, R., additional, Wekerle, T., additional, Bühler, L.H., additional, Labbate, A., additional, Perry, K., additional, and Wielgus, J., additional

Published
2016
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79. Design and implementation of the international genetics and translational research in transplantation network

Author

Keating, BJ, Van Setten, J, Jacobson, PA, Holmes, MV, Verma, SS, Chandrupatla, HR, Nair, N, Gao, H, Li, YR, Chang, BL, Wong, C, Phillips, R, Cole, BS, Mukhtar, E, Zhang, W, Cao, H, Mohebnasab, M, Hou, C, Lee, T, Steel, L, Shaked, O, Garifallou, J, Miller, MB, Karczewski, KJ, Akdere, A, Gonzalez, A, Lloyd, KM, McGinn, D, Michaud, Z, Colasacco, A, Lek, M, Fu, Y, Pawashe, M, Guettouche, T, Himes, A, Perez, L, Guan, W, Wu, B, Schladt, D, Menon, M, Zhang, Z, Tragante, V, De Jonge, N, Otten, HG, De Weger, RA, Van De Graaf, EA, Baan, CC, Manintveld, OC, De Vlaminck, I, Piening, BD, Strehl, C, Shaw, M, Snieder, H, Klintmalm, GB, O'Leary, JG, Amaral, S, Goldfarb, S, Rand, E, Rossano, JW, Kohli, U, Heeger, P, Stahl, E, Christie, JD, Fuentes, MH, Levine, JE, Aplenc, R, Schadt, EE, Stranger, BE, Kluin, J, Potena, L, Zuckermann, A, Khush, K, Alzahrani, AJ, Al-Muhanna, FA, Al-Ali, AK, Al-Ali, R, Al-Rubaish, AM, Al-Mueilo, S, Byrne, EM, Miller, D, Alexander, SI, Onengut-Gumuscu, S, Rich, SS, Suthanthiran, M, Tedesco, H, Saw, CL, Ragoussis, J, Kfoury, AG, Horne, B, Carlquist, J, Gerstein, MB, Reindl-Schwaighofer, R, Oberbauer, R, Wijmenga, C, Palmer, S, Pereira, AC, Segovia, J, Alonso-Pulpon, LA, Comez-Bueno, M, Vilches, C, Keating, BJ, Van Setten, J, Jacobson, PA, Holmes, MV, Verma, SS, Chandrupatla, HR, Nair, N, Gao, H, Li, YR, Chang, BL, Wong, C, Phillips, R, Cole, BS, Mukhtar, E, Zhang, W, Cao, H, Mohebnasab, M, Hou, C, Lee, T, Steel, L, Shaked, O, Garifallou, J, Miller, MB, Karczewski, KJ, Akdere, A, Gonzalez, A, Lloyd, KM, McGinn, D, Michaud, Z, Colasacco, A, Lek, M, Fu, Y, Pawashe, M, Guettouche, T, Himes, A, Perez, L, Guan, W, Wu, B, Schladt, D, Menon, M, Zhang, Z, Tragante, V, De Jonge, N, Otten, HG, De Weger, RA, Van De Graaf, EA, Baan, CC, Manintveld, OC, De Vlaminck, I, Piening, BD, Strehl, C, Shaw, M, Snieder, H, Klintmalm, GB, O'Leary, JG, Amaral, S, Goldfarb, S, Rand, E, Rossano, JW, Kohli, U, Heeger, P, Stahl, E, Christie, JD, Fuentes, MH, Levine, JE, Aplenc, R, Schadt, EE, Stranger, BE, Kluin, J, Potena, L, Zuckermann, A, Khush, K, Alzahrani, AJ, Al-Muhanna, FA, Al-Ali, AK, Al-Ali, R, Al-Rubaish, AM, Al-Mueilo, S, Byrne, EM, Miller, D, Alexander, SI, Onengut-Gumuscu, S, Rich, SS, Suthanthiran, M, Tedesco, H, Saw, CL, Ragoussis, J, Kfoury, AG, Horne, B, Carlquist, J, Gerstein, MB, Reindl-Schwaighofer, R, Oberbauer, R, Wijmenga, C, Palmer, S, Pereira, AC, Segovia, J, Alonso-Pulpon, LA, Comez-Bueno, M, and Vilches, C

Abstract

Background. Genetic association studies of transplantation outcomes have been hampered by small samples and highly complex multifactorial phenotypes, hindering investigations of the genetic architecture of a range of comorbidities which significantly impact graft and recipient life expectancy. We describe here the rationale and design of the International Genetics & Translational Research in Transplantation Network. The network comprises 22 studies to date, including 16 494 transplant recipients and 11 669 donors, of whom more than 5000 are of non-European ancestry, all of whom have existing genomewide genotype data sets. Methods. We describe the rich genetic and phenotypic information available in this consortium comprising heart, kidney, liver, and lung transplant cohorts. Results. We demonstrate significant power in International Genetics & Translational Research in Transplantation Network to detect main effect association signals across regions such as the MHC region as well as genomewide for transplant outcomes that span all solid organs, such as graft survival, acute rejection, new onset of diabetes after transplantation, and for delayed graft function in kidney only. Conclusions. This consortium is designed and statistically powered to deliver pioneering insights into the genetic architecture of transplant-related outcomes across a range of different solid-organ transplant studies. The study design allows a spectrum of analyses to be performed including recipient-only analyses, donor-recipient HLA mismatches with focus on loss-of-function variants and nonsynonymous single nucleotide polymorphisms.

Published
2015

82. MicroRNAs in kidney transplantation

Author

Wilflingseder, J., primary, Reindl-Schwaighofer, R., additional, Sunzenauer, J., additional, Kainz, A., additional, Heinzel, A., additional, Mayer, B., additional, and Oberbauer, R., additional

Published
2014
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85. TRANSPLANTATION 2

Author

Orandi, B. J., primary, Kraus, E. S., additional, Bagnasco, S. M., additional, Van Arendonk, K. J., additional, Garonzik-Wang, J. M., additional, Wickliffe, C., additional, Montgomery, R. A., additional, Segev, D. L., additional, Trivedi, H. L., additional, Vanikar, A. V., additional, Dave, S. D., additional, Patel, H. V., additional, Kute, V. B., additional, Gumber, M. R., additional, Rawal, M. N., additional, Modi, P. R., additional, Rizvi, S. J., additional, Sicard, A., additional, Ducreux, S., additional, Rabeyrin, M., additional, McGregor, B., additional, Badet, L., additional, Scoazec, J.-Y., additional, Fremeau-Bacchi, V., additional, Morelon, E., additional, Dubois, V., additional, Thaunat, O., additional, Kiki ,  eljko, additional, Kainz, A., additional, Kozakowski, N., additional, Oberbauer, R., additional, Regele, H., additional, Bartel, G., additional, Boehmig, G. A., additional, Mallamaci, F., additional, Tripepi, R., additional, Leonardis, D., additional, Mafrica, A., additional, Versace, M. C., additional, Provenzano, F., additional, Tripepi, G., additional, and Zoccali, C., additional

Published
2014
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86. AKI - human studies

Author

Kutlay, S., primary, Kurultak, I., additional, Nergizoglu, G., additional, Erturk, S., additional, Karatan, O., additional, Azevedo, P., additional, Pinto, C. T., additional, Pereira, C. M., additional, Marinho, A., additional, Vanmassenhove, J., additional, Hoste, E., additional, Glorieux, G., additional, Dhondt, A., additional, Vanholder, R., additional, Van Biesen, W., additional, Rei, S., additional, Aleksandrova, I., additional, Kiselev, V., additional, Ilynskiy, M., additional, Berdnikov, G., additional, Marchenkova, L., additional, Daher, E. F., additional, Vieira, A. P. F., additional, Souza, J. B., additional, Falcao, F. S., additional, Costa, C. R., additional, Fernandes, A. A. C. S., additional, Mota, R. M. S., additional, Lima, R. S. A., additional, Silva Junior, G. B., additional, Ulusal Okyay, G., additional, Erten, Y., additional, Er, R., additional, Aybar, M., additional, Inal, S., additional, Tekbudak, M., additional, Aygencel, G., additional, Onec, K., additional, Bali, M., additional, Sindel, S., additional, Soto, K., additional, Fidalgo, P., additional, Papoila, A. L., additional, Lentini, P., additional, Zanoli, L., additional, Granata, A., additional, Contestabile, A., additional, Basso, A., additional, Berlingo, G., additional, de Cal, M., additional, Pellanda, V., additional, Dell'Aquila, R., additional, Fortrie, G., additional, Stads, S., additional, van Bommel, J., additional, Zietse, R., additional, Betjes, M. G., additional, Berrada, A., additional, Arias, C., additional, Riera, M., additional, Orfila, M. A., additional, Rodriguez, E., additional, Barrios, C., additional, Peruzzi, L., additional, Chiale, F., additional, Camilla, R., additional, Martano, C., additional, Cresi, F., additional, Bertino, E., additional, Coppo, R., additional, Klimenko, A., additional, Villevalde, S., additional, Efremovtseva, M., additional, Kobalava, Z., additional, Pipili, C., additional, Ioannidou, S., additional, Kokkoris, S., additional, Poulaki, S., additional, Tripodaki, E.-S., additional, Parisi, M., additional, Papastylianou, A., additional, Nanas, S., additional, Wang, Y.-n., additional, Cheng, H., additional, Chen, Y.-p., additional, Wen, Z., additional, Li, X., additional, Shen, P., additional, Zou, Y., additional, Lu, Y., additional, Ma, X., additional, Chen, Y., additional, Ren, H., additional, Chen, X., additional, Chen, N., additional, Yue, T., additional, Elmamoun, S., additional, Wodeyar, H., additional, Goldsmith, C., additional, Abraham, A., additional, Wootton, A., additional, Ahmed, S., additional, Hill, C., additional, Curtis, S., additional, Miller, A., additional, Hine, T., additional, Stevens, K. K., additional, Patel, R. K., additional, Mark, P. B., additional, Delles, C., additional, Jardine, A. G., additional, Wilflingseder, J., additional, Heinzel, A., additional, Mayer, P., additional, Perco, P., additional, Kainz, A., additional, Mayer, B., additional, Oberbauer, R., additional, Huang, T.-M., additional, Wu, V.-C., additional, Park, D. J., additional, Bae, E. J., additional, Kang, Y.-J., additional, Cho, H. S., additional, Chang, S.-h., additional, Stramana, R., additional, Cognolato, D., additional, Baiocchi, M., additional, Chiella, B. M., additional, Pilla, C., additional, Balbinotto, A., additional, Antunes, V. H., additional, Heglert, A., additional, Collares, F. M., additional, Thome, F. S., additional, Gjyzari, A., additional, Thereska, N., additional, Xhango, O., additional, Xue, J., additional, Chen, M. C., additional, Wang, L., additional, Chen, Y. J., additional, Sun, X. Z., additional, An, W. S., additional, Kim, E. S., additional, Son, Y. K., additional, Kim, S. E., additional, Kim, K. H., additional, Oh, Y. J., additional, Tsai, H.-B., additional, Ko, W.-J., additional, Chao, C.-T., additional, Aarnoudse, A.-J. L., additional, Peride, I., additional, Radulescu, D., additional, Niculae, A., additional, Ciocalteu, A., additional, Checherita, A.-I., additional, Kao, C.-C., additional, Wang, C.-Y., additional, Lai, C.-F., additional, Chen, H.-H., additional, Wu, K.-D., additional, Klaus, F., additional, Goldani, J. C., additional, Cantisani, G., additional, Zanotelli, M. L., additional, Carvalho, L., additional, Klaus, D., additional, Garcia, V. D., additional, Keitel, E., additional, Hussaini, S. M., additional, Rao, P. N., additional, Kul, A., additional, Ye, N., additional, Zhang, Y., additional, Baines, R., additional, Westacott, R., additional, Trew, J., additional, Kirtley, J., additional, Selby, N., additional, Carr, S., additional, Xu, G., additional, Steffgen, J., additional, Blaschke, S., additional, Brun-Schulte-Wissing, N., additional, Pagel, P., additional, Huber, F., additional, Mapes, J., additional, Jaehnige, A., additional, Pestel, S., additional, Deray, G., additional, Rouviere, O., additional, Bacigalupo, L., additional, Maes, B., additional, Hannedouche, T., additional, Vrtovsnik, F., additional, Rigothier, C., additional, Billiouw, J.-M., additional, Campioni, P., additional, Marti-Bonmati, L., additional, Gao, Y.-m., additional, Li, D., additional, Woo, S., additional, Lee, J., additional, Noh, H., additional, Kwon, S. H., additional, Han, D. C., additional, Hetherington, L., additional, Valluri, A., additional, McQuarrie, E., additional, Fleming, S., additional, Geddes, C., additional, Bell, S., additional, MacKinnon, B., additional, Patton, A., additional, Sneddon, J., additional, Donnan, P., additional, Vadiveloo, T., additional, Marwick, C., additional, Bennie, M., additional, Davey, P., additional, Yasuda, H., additional, Tsuji, N., additional, Tsuji, T., additional, Iwakura, T., additional, Ohashi, N., additional, Kato, A., additional, Fujigaki, Y., additional, Sasaki, S., additional, Kawarazaki, H., additional, Shibagaki, Y., additional, Kimura, K., additional, Lingaraju, U., additional, Rajanna, S., additional, Radhakrishnan, H., additional, Parekh, A., additional, Sreedhar, C. G., additional, Sarvi, R., additional, Rainone, F., additional, Merlino, L., additional, Ritchie, J. P., additional, Kalra, P. A., additional, Jacinto, C. N., additional, Abreu, K. L. S., additional, Neves, M., additional, Baptista, J. P., additional, Rodrigues, L., additional, Pinho, J., additional, Teixeira, L., additional, Pimentel, J., additional, Gonzalez Sanchidrian, S., additional, Rangel Hidalgo, G., additional, Cebrian Andrada, C., additional, Deira Lorenzo, J., additional, Marin Alvarez, J., additional, Garcia-Bernalt Funes, V., additional, Gallego Dominguez, S., additional, Labrador Gomez, P., additional, Castellano Cervino, I., additional, Novillo Santana, R., additional, Gomez-Martino Arroyo, J., additional, Kim, Y., additional, Choi, B. S., additional, Kim, Y. o., additional, Yoon, S. A., additional, Lin, M.-C., additional, Wang, W.-J., additional, Melo, M. J., additional, Lopes, J. A., additional, Raimundo, M., additional, Fragoso, A., additional, Antunes, F., additional, Martin-Moreno, P. L., additional, Varo, N., additional, Restituto, P., additional, Sayon-Orea, C., additional, Garcia-Fernandez, N., additional, Leite Filho, N. C. V., additional, Souza, L. E. O., additional, Cavalcante, R. M., additional, Morais, B. M., additional, Leite, T. T., additional, Silva, S. L., additional, Kubrusly, M., additional, Jung, Y. S., additional, Kim, Y. N., additional, Shin, H. S., additional, Rim, H., additional, Bentall, A., additional, Al-Baaj, F., additional, Williamson, S., additional, Cheshire, S., additional, Jelakovic, M., additional, Ivkovic, V., additional, Laganovic, M., additional, Karanovic, S., additional, Pecin, I., additional, Premuzic, V., additional, Vukovic Lela, I., additional, Vrdoljak, A., additional, Fucek, M., additional, Cvitkovic, A., additional, Juric, D., additional, Bozina, N., additional, Bitunjac, M., additional, Leko, N., additional, Abramovic Baric, M., additional, Matijevic, V., additional, Jelakovic, B., additional, Ullah, A., additional, Exarchou, K., additional, Archer, T., additional, Anijeet, H., additional, Brown, R., additional, Cheng, Y.-p., additional, Rocha, J. C. G., additional, Gushiken da Silva, T., additional, de Castro, P. F., additional, Kioroglo, P. S., additional, Branco Martins, J. P., additional, Tzanno-Martins, C., additional, Biesenbach, P., additional, Luf, F., additional, Fleischmann, E., additional, Grunberger, T., additional, Druml, W., additional, Gaipov, A., additional, Turkmen, K., additional, Toker, A., additional, Solak, Y., additional, Cicekler, H., additional, Ucar, R., additional, Kilicaslan, A., additional, Gormus, N., additional, Tonbul, H. Z., additional, Yeksan, M., additional, Turk, S., additional, Monteburini, T., additional, Cenerelli, S., additional, Santarelli, S., additional, Boggi, R., additional, Tazza, L., additional, Bossola, M., additional, Ferraresi, M., additional, Merlo, I., additional, Giovinazzo, G., additional, Quercia, A. D., additional, Gai, M., additional, Leonardi, G., additional, Anania, P., additional, Guarena, C., additional, Cantaluppi, V., additional, Pacitti, A., additional, Biancone, L., additional, Hissa, P. N. G., additional, Daher, E. D. F., additional, Liborio, A. B., additional, Thereza, B. M. F., additional, Mendes, C. C. P., additional, and Sousa, A. R. O., additional

Published
2013
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90. Peritoneal dialysis

Author

Beck, F.-X., primary, Kuper, C., additional, Neuhofer, W., additional, Rodrigues-Diez, R., additional, Stark Aroeira, L. G., additional, Jimenez, J. A., additional, Rayego-Mateos, S., additional, Bajo Rubio, A., additional, Ortiz, A., additional, Egido, J., additional, Lopez-Cabrera, M., additional, Selgas, R., additional, Ruiz-Ortega, M., additional, Pedro Ventura, A., additional, Olivia, S., additional, Teixeira, L., additional, Joana, V., additional, Francisco, F., additional, Maria Joao, C., additional, Antonio, C., additional, Rodrigues, A. S., additional, Vychytil, A., additional, Kerschbaum, J., additional, Lhotta, K., additional, Prischl, F., additional, Wiesholzer, M., additional, Kopriva-Altfahrt, G., additional, Machold-Fabrizii, V., additional, Schwarz, C., additional, Balcke, P., additional, Oberbauer, R., additional, Kramar, R., additional, Konig, P., additional, Rudnicki, M., additional, Habib, M., additional, Betjes, M., additional, Korte, M., additional, Vidal, E., additional, Edefonti, A., additional, Chimenz, R., additional, Gianoglio, B., additional, Leozappa, G., additional, Maringhini, S., additional, Mencarelli, F., additional, Pecoraro, C., additional, Puteo, F., additional, Testa, S., additional, Cannavo, R., additional, and Verrina, E., additional

Published
2012
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