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1. Physical Activity versus Sclerostin and Interleukin 6 Concentration in Patients Receiving Renal Replacement Therapy by Hemodialysis

Author

Turoń-Skrzypińska A, Dutkiewicz G, Marchelek-Myśliwiec M, Rył A, Dziedziejko V, Safranow K, Ciechanowski K, and Rotter I

Subjects
physical activity, hemodialysis, sclerostin, interleukin 6, Public aspects of medicine, RA1-1270
Abstract

Agnieszka Turoń-Skrzypińska,1,* Grażyna Dutkiewicz,2,* Małgorzata Marchelek-Myśliwiec,2 Aleksandra Rył,1 Violetta Dziedziejko,3 Krzysztof Safranow,3 Kazimierz Ciechanowski,2 Iwona Rotter1 1Department of Medical Rehabilitation and Clinical Rehabilitation, Pomeranian Medical University, Szczecin 71-210, Poland; 2Department of Nephrology, Transplantology and Internal Medicine, Pomeranian Medical University, Szczecin 70-111, Poland; 3Department of Biochemistry and Medical Chemistry, Pomeranian Medical University, Szczecin 70-111, Poland*These authors contributed equally to this workCorrespondence: Agnieszka Turoń-Skrzypińska Email agi.skrzypinska@gmail.comIntroduction: Chronic kidney disease and renal replacement therapy are associated with reduced motor activity, which may result in the presence of mineral bone disorders and an increase in inflammation markers. The aim of the study was to assess the relationship between the performance of daily physical activity, expressed in the number of steps performed by patients undergoing hemodialysis and the concentration of selected biochemical parameters (SCL, IL-6).Patients and Methods: The study group (B) involved 33 patients aged 59.8 ± 9.8 years from the dialysis station at the Department of Nephrology, Transplantology and Internal Medicine PUM. In group B, interventions considering an increase in physical activity expressed in the number of steps were introduced. Group C consisted of 30 people aged 54.9 (9.37), with GFR over 60 mL/min/1.73m. Physical activity was measured with pedometers. Anthropometric and biochemical parameters were assessed at baseline, after the third and sixth month of the study. Descriptive statistics, intergroup comparisons using Mann–Whitney U test and Spearman correlation analysis were performed. The level of significance was set at p≤ 0.005.Results: A relationship between IL-6 concentration and the number of steps in group B after three months of intervention was demonstrated. In group C, the concentration of SCL and IL-6 decreased with the increase in the number of steps taken. Only in group C the waist circumference decreased with the increase of the number of steps performed.Conclusion: Patients receiving renal replacement therapy by hemodialysis showed significantly lower physical activity compared to people without kidney disease. Performing bigger number of steps can lower interleukin 6 levels in hemodialysis patients.Keywords: physical activity, hemodialysis, sclerostin, interleukin 6

Published
2020

2. The influence of intrauterine exposure to immunosuppressive treatment on changes in the immune system in juvenile Wistar rats

Author

Kabat-Koperska J, Kolasa-Wołosiuk A, Wojciuk B, Wojciechowska-Koszko I, Roszkowska P, Krasnodębska-Szponder B, Paczkowska E, Safranow K, Gołembiewska E, Machaliński B, and Ciechanowski K

Subjects
immune system, immunosuppressive drugs, kidney transplantation, pregnancy, Wistar rats, Therapeutics. Pharmacology, RM1-950
Abstract

Joanna Kabat-Koperska,1 Agnieszka Kolasa-Wołosiuk,2 Bartosz Wojciuk,3 Iwona Wojciechowska-Koszko,3 Paulina Roszkowska,3 Barbara Krasnodębska-Szponder,3 Edyta Paczkowska,4 Krzysztof Safranow,5 Edyta Gołembiewska,1 Bogusław Machaliński,4 Kazimierz Ciechanowski1 1Department of Nephrology, Transplantology and Internal Medicine, 2Department of Histology and Embryology, 3Department of Microbiology and Immunological Diagnostics, 4Department of General Pathology, 5Department of Biochemistry and Medical Chemistry, Pomeranian Medical University, Szczecin, Poland Background: In our study, we assessed the impact of immunosuppressive drug combinations on changes in the immune system of juvenile Wistar rats exposed to these drugs during pregnancy. We primarily concentrated on changes in two organs of the immune system – the thymus and the spleen. Methods: The study was conducted on 40 (32+8) female Wistar rats administered full and half dose of drugs, respectively, subjected to regimens commonly used in therapy of human kidney transplant recipients ([1] cyclosporine A, mycophenolate mofetil, and prednisone; [2] tacrolimus, mycophenolate mofetil, and prednisone; [3] cyclosporine A, everolimus, and prednisone). The animals received drugs by oral gavage 2 weeks before pregnancy and during 3 weeks of pregnancy. Results: There were no statistically significant differences in the weight of the thymus and spleen, but changes were found in the results of blood hematology, cytometry from the spleen, and a histologic examination of the examined immune organs of juvenile Wistar rats. In the cytokine assay, changes in the level of interleukine 17 (IL-17) after increasing amounts of concanavaline A were dose-dependent; the increase of IL-17 was blocked after administration of higher doses of immunosuppressive drugs. However, after a reduction of doses, its increase resumed. Conclusion: Qualitative, quantitative, and morphological changes in the immune system of infant rats born to pharmacologically immunosuppressed females were observed. Thymus structure, spleen composition, and splenocyte IL-17 production were mostly affected in a drug regimen–dependent manner. Keywords: immune system, immunosuppressive drugs, kidney transplantation, pregnancy, Wistar rats

Published
2016

3. Effects of immunosuppressive treatment on protein expression in rat kidney

Author

Kędzierska K, Sporniak-Tutak K, Sindrewicz K, Bober J, Domański L, Parafiniuk M, Urasińska E, Ciechanowicz A, Domański M, Smektała T, Masiuk M, Skrzypczak W, Ożgo M, Kabat-Koperska J, and Ciechanowski K,

Subjects
Therapeutics. Pharmacology, RM1-950
Abstract

Karolina Kędzierska,1 Katarzyna Sporniak-Tutak,2 Krzysztof Sindrewicz,2 Joanna Bober,3 Leszek Domański,1 Mirosław Parafiniuk,4 Elżbieta Urasińska,5 Andrzej Ciechanowicz,6 Maciej Domański,1 Tomasz Smektała,2 Marek Masiuk,5 Wiesław Skrzypczak,6 Małgorzata Ożgo,6 Joanna Kabat-Koperska,1 Kazimierz Ciechanowski1 1Department of Nephrology, Transplantology, and Internal Medicine, 2Department of Dental Surgery, 3Department of Medical Chemistry, 4Department of Forensic Medicine, 5Department of Pathomorphology, Pomeranian Medical University, 6Department of Physiology, Cytobiology, and Proteomics, West Pomeranian University of Technology, Szczecin, Poland Abstract: The structural proteins of renal tubular epithelial cells may become a target for the toxic metabolites of immunosuppressants. These metabolites can modify the properties of the proteins, thereby affecting cell function, which is a possible explanation for the mechanism of immunosuppressive agents' toxicity. In our study, we evaluated the effect of two immunosuppressive strategies on protein expression in the kidneys of Wistar rats. Fragments of the rat kidneys were homogenized after cooling in liquid nitrogen and then dissolved in lysis buffer. The protein concentration in the samples was determined using a protein assay kit, and the proteins were separated by two-dimensional electrophoresis. The obtained gels were then stained with Coomassie Brilliant Blue, and their images were analyzed to evaluate differences in protein expression. Identification of selected proteins was then performed using mass spectrometry. We found that the immunosuppressive drugs used in popular regimens induce a series of changes in protein expression in target organs. The expression of proteins involved in drug, glucose, amino acid, and lipid metabolism was pronounced. However, to a lesser extent, we also observed changes in nuclear, structural, and transport proteins' synthesis. Very slight differences were observed between the group receiving cyclosporine, mycophenolate mofetil, and glucocorticoids (CMG) and the control group. In contrast, compared to the control group, animals receiving tacrolimus, mycophenolate mofetil, and glucocorticoids (TMG) exhibited higher expression of proteins responsible for renal drug metabolism and lower expression levels of cytoplasmic actin and the major urinary protein. In the TMG group, we observed higher expression of proteins responsible for drug metabolism and a decrease in the expression of respiratory chain enzymes (thioredoxin-2) and markers of distal renal tubular damage (heart fatty acid-binding protein) compared to expression in the CMG group. The consequences of the reported changes in protein expression require further study. Keywords: Proteomics, drug effects, immunosuppression, rats

Published
2014

4. A pre-specified analysis of the Dapagliflozin and Prevention of Adverse Outcomes in Chronic Kidney Disease (DAPA-CKD) randomized controlled trial on the incidence of abrupt declines in kidney function

Author

Heerspink, Hiddo J.L., Wheeler, David C., Chertow, Glenn, Correa-Rotter, Ricardo, Greene, Tom, Hou, Fan Fan, McMurray, John, Rossing, Peter, Toto, Robert, Stefansson, Bergur, Langkilde, Anna Maria, Maffei, L.E., Raffaele, P., Solis, S.E., Arias, C.A., Aizenberg, D., Luquez, C., Zaidman, C., Cluigt, N., Mayer, M., Alvarisqueta, A., Wassermann, A., Maldonado, R., Bittar, J., Maurich, M., Gaite, L.E., Garcia, N., Sivak, L., Ramallo, P.O., Santos, J.C., Garcia Duran, R., Oddino, J.A., Maranon, A., Maia, L.N., Avila, D.D., Barros, E.J.G., Vidotti, M.H., Panarotto, D., Noronha, I.D.L., Turatti, L.A.A., Deboni, L., Canziani, M.E., Riella, M.C., Bacci, M.R., Paschoalin, R.P., Franco, R.J., Goldani, J.C., St-Amour, E., Steele, A.W., Goldenberg, R., Pandeya, S., Bajaj, H., Cherney, D., Kaiser, S.M., Conway, J.R., Chow, S.S., Bailey, G., Lafrance, J., Winterstein, J., Cournoyer, S., Gaudet, D., Madore, F., Houlden, R.L., Dowell, A., Langlois, M., Muirhead, N., Khandwala, H., Levin, A., Hou, F., Xue, Y., Zuo, L., Hao, C., Ni, Z., Xing, C., Chen, N., Dong, Y., Zhou, R., Xiao, X., Zou, Y., Wang, C., Liu, B., Chen, Q., Lin, M., Luo, Q., Zhang, D., Wang, J., Chen, M., Wang, X., Zhong, A., Dong, J., Zhu, C., Yan, T., Luo, P., Ren, Y., Pai, P., Li, D., Zhang, R., Zhang, J., Xu, M., Zhuang, Y., Kong, Y., Yao, X., Peng, X., Persson, F.I., Hansen, T.K., Borg, R., Pedersen Bjergaard, U., Hansen, D., Hornum, M., Haller, H., Klausmann, G., Tschope, D., Kruger, T., Gross, P., Hugo, C., Obermuller, N., Rose, L., Mertens, P., Zeller-Stefan, H., Fritsche, A., Renders, L., Muller, J., Budde, K., Schroppel, B., Wittmann, I., Voros, P., Dudas, M., Tabak, G.A., Kirschner, R., Letoha, A., Balku, I., Hermanyi, Z., Zakar, G., Mezei, I., Nagy, G.G., Lippai, J., Nemeth, A., Khullar, D., Gowdaiah, P.K., Fernando Mervin, E., Rao, V.A., Dewan, D., Goplani, K., Maddi, V.S.K., Vyawahare, M.S., Pulichikkat, R.K., Pandey, R., Sonkar, S.K., Gupta, V.K., Agarwal, S., Asirvatham, A.J., Ignatius, A., Chaubey, S., Melemadathil, S., Alva, H., Kadam, Y., Shimizu, H., Sueyoshi, A., Takeoka, H., Abe, Y., Imai, T., Onishi, Y., Fujita, Y., Tokita, Y., Oura, M., Makita, Y., Idogaki, A., Koyama, R., Kikuchi, H., Kashihara, N., Hayashi, T., Ando, Y., Tanaka, T., Shimizu, M., Hidaka, S., Gohda, T., Tamura, K., Abe, M., Kamijo, Y., Imasawa, T., Takahashi, Y., Nakayama, M., Tomita, M., Hirano, F., Fukushima, Y., Kiyosue, A., Kurioka, S., Imai, E., Kitagawa, K., Waki, M., Wada, J., Uehara, K., Iwatani, H., Ota, K., Shibazaki, S., Katayama, K., Narita, I., Iinuma, M., Matsueda, S., Sasaki, S., Yokochi, A., Tsukamoto, T., Yoshimura, T., Kang, S., Lee, S., Lim, C.S., Chin, H., Joo, K.W., Han, S.Y., Chang, T.I., Park, S., Park, H., Park, C.W., Han, B.G., Cha, D.R., Yoon, S.A., Kim, W., Kim, S.W., Ryu, D., Correa Rotter, R., Irizar Santana, S.S., Hernandez Llamas, G., Valdez Ortiz, R., Secchi Nicolas, N.C., Gonzalez Galvez, G., Lazcano Soto, J.R., Bochicchio Riccardelli, T., Bayram Llamas, E.A., Ramos Ibarra, D.R., Melo, M.G.S., Gonzalez Gonzalez, J.G., Sanchez Mijangos, J.H., Madero Robalo, M., Garcia Castillo, A., Manrique, H.A., Farfan, J.C., Vargas, R., Valdivia, A., Dextre, A., Escudero, E., Calderon Ticona, J.R., Gonzales, L., Villena, J., Leon, L., Molina, G., Saavedra, A., Garrido, E., Arbanil, H., Vargas Marquez, S., Rodriguez, J., Isidto, R., Villaflor, A.J., Gumba, M.A., Tirador, L., Comia, R.S., Sy, R.A., Guanzon, M.L.V.V., Aquitania, G., De Asis, N.C., Silva, A.A., Romero, C.M., Lim, M.E., Danguilan, R.A., Nowicki, M., Rudzki, H., Landa, K., Kucharczyk-Bauman, I., Gogola-Migdal, B., Golski, M., Olech-Cudzik, A., Stompor, T., Szczepanik, T., Miklaszewicz, B., Sciborski, R., Kuzniewski, M., Ciechanowski, K., Wronska, D., Klatko, W., Mazur, S., Popenda, G., Myslicki, M., Bolieva, L.Z., Berns, S., Galyavich, A., Abissova, T., Karpova, I., Platonov, D., Koziolova, N., Kvitkova, L., Nilk, R., Medina, T., Rebrov, A., Rossovskaya, M., Sinitsina, I., Vishneva, E., Zagidullin, N., Novikova, T., Krasnopeeva, N., Magnitskaya, O., Antropenko, N., Batiushin, M., Escudero Quesada, V., Barrios Barrea, C., Espinel Garauz, E., Cruzado Garrit, J.M., Morales Portillo, C., Gorriz Teruel, J.L., Cigarran Guldris, S., Praga Terente, M., Robles Perez-Monteoliva, N.R., Tinahones Madueno, F.J., Soto Gonzalez, A., Diaz Rodriguez, C., Furuland, H., Saeed, A., Dreja, K., Spaak, J., Bruchfeld, A., Kolesnyk, M., Levchenko, O., Pyvovarova, N., Stus, V., Doretskyy, V., Korobova, N., Horoshko, O., Katerenchuk, I., Mostovoy, Y.M., Orynchak, M., Legun, O., Dudar, I., Bilchenko, O., Andreychyn, S., Levchenko, A., Zub, L., Tereshchenko, N., Topchii, I., Ostapenko, T., Bezuglova, S., Kopytsya, M., Turenko, O., Mark, P., Barratt, J., Bhandari, S., Fraser, D., Kalra, P., Kon, S.P., Mccafferty, K., Mikhail, A., Alvarado, O.P., Anderson, R., Andrawis, N.S., Arif, A., Benjamin, S.A., Bueso, G., Busch, R.S., Carr, K.W., Crawford, P., Daboul, N., De La Calle, G.M., Delgado, B., Earl, J., El-Shahawy, M.A., Graf, R.J., Greenwood, G., Guevara, A., Wendland, E.M., Mayfield, R.K., Montero, M., Morin, D.J., Narayan, P., Numrungroad, V., Reddy, A.C., Reddy, R., Samson, M.B., Trejo, R., Butcher, M.B., Wise, J.K., Zemel, L.R., Raikhel, M., Weinstein, D., Hernandez, P., Wynne, A., Khan, B.V., Sterba, G.A., Jamal, A., Ross, D., Rovner, S.F., Tan, A., Ovalle, F., Patel, R.J., Talano, J., Patel, D.R., Burgner, A., Aslam, N., Elliott, M., Goral, S., Jovanovich, A., Manley, J.A., Umanath, K., Waguespack, D., Weiner, D., Yu, M., Schneider, L., Jalal, D., Le, T., Nguyen, N., Nguyen, H., Nguyen, D., Nguyen, V., Do, T., Chu, P., Ta, D., Tran, N., Pham, B., Pfeffer, Marc A., Pocock, Stuart, Swedberg, Karl, Rouleau, Jean L., Chaturvedi, Nishi, Ivanovich, Peter, Levey, Andrew S., Christ-Schmidt, Heidi, Held, Claes, Christersson, Christina, Mann, Johannes, Varenhorst, Christoph, Cherney, David, Postmus, Douwe, Stefánsson, Bergur V., Chertow, Glenn M., Dwyer, Jamie P., Kosiborod, Mikhail, McMurray, John J.V., Sjöström, C. David, and Toto, Robert D.

Published
2022
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36. Bone Metabolism Parameters in Hemodialysis Patients With Chronic Kidney Disease and in Patients After Kidney Transplantation

Author

Marchelek-Myśliwiec, M., primary, Dziedziejko, V., additional, Nowosiad-Magda, M., additional, Wiśniewska, M., additional, Safranow, K., additional, Pawlik, A., additional, Domański, L., additional, Dołęgowska, K., additional, Dołęgowska, B., additional, Stępniewska, J., additional, and Ciechanowski, K., additional

Published
2019
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37. Tolvaptan in Patients with Autosomal Dominant Polycystic Kidney Disease

Author

Torres VE, Chapman AB, Devuyst O, Gansevoort RT, Grantham JJ, Higashihara E, Perrone RD, Krasa HB, Ouyang J, Czerwiec FS, Tempo team, Gross P, Schulze B, Bichet D, Chauveau D, Peeters P, Voiculescu M, Manunta P, Tuazon J, Watnick T, Goral S, Horie S, Nutahara K, Torres V, Chapman A, Gansevoort R, Perrone R, Czerwiec F, Goldstein S, Cowley B, Fukagawa M, Torra R, Wei LJ, Cook T, Toto R, Agarwal R, August P, Bakris G, Beddhu S, Corwin H, Ruilope L, Rosa-Diez G, De La Fuente J, Martin R, Massari P, Novoa P, Rial M, Wasserman A, Faull R, Fraser I, Johnson D, Pedagagos E, Lian M, Pollock C, Cooper B, Rangan G, Russ G, McDonald S, Thomas M, Khoo D, Walker R, Pirson Y, Laecke V, Van der Niepen P, Sennesael J, Barre P, Alam A, Soroka S, Dieperink H, Strandgaard S, Petersen L, Berthoux F, Canaud B, Gontiers-Picard A, Huart A, Combe C, Delmas Y, Dussol B, Laville M, Guebre-Egziabher F, Mignon F, Michel C, Rieu P, Noel N, Ryckelynck J, Lobbedez T, Dellanna F, Kleophas W, Feldkamp T, Witzke O, Nurnberger J, Zeltner R, Walz G, Zeier M, Sommerer C, Bianchi S, Capasso G, Miranda N, Magistroni R, Bracale M, Remuzzi G, Rota S, Villa G, Tilocca P, Asahi K, Kato T, Endo M, Umezono T, Fujigaki Y, Kato A, Fukatsu A, Hasegawa H, Tayama Y, Hasegawa M, Hosoya T, Hanaoka K, Iehara N, Iino Y, Tsuruoka S, Imai E, Isaka Y, Ishimura E, Ito S, Sato H, Kamata K, Sakamoto H, Kamura K, Kusano E, Muto S, Kuwahara M, Matsubara A, Yorioka N, Mochizuki T, Narita I, Naya Y, Nihei N, Yukio N, Nishio S, Nitta K, Tsuchiya K, Okamura M, Sasaki S, Rai T, Seta K, Sugawara A, Shibazaki S, Sugiyama S, Tabei K, Takaichi K, Tomita K, Kitamura K, Tsukamoto Y, Tsuruya K, Nakano T, Ubara Y, Watanabe T, Yamamoto T, Yoshida K, Ishii D, Yuzawa Y, Meijer E, Vervloet M, Ciechanowski K, Wisniewska M, Gutowska-Jablonska M, Marcinkowska-Królewicz M, Klatko W, Wiśniewski T, Klinger M, Krajewska M, Ksiazek A, Orłowska G, Malecki R, Gontarek-Kacprzak J, Nowicki M, Makówka A, Rutkowski B, Wołyniec W, Rydzewski A, Sulowicz W, Jasik P, Covic A, Volovat C, Mircescu G, Petrescu L, Bobeica R, Barbarash O, Chesnokova L, Borovoy S, Demina L, Shostka G, Idovu M, Tkalich L, Geynits O, Tomilina N, Foggensteiner L, Holt S, Kingswood J, Lambie S, Peel R, MacDougall I, Tucker B, MacPhee I, Maxwell A, Brown H, Mikhail A, Bastin L, Turner N, Neary J, Wheeler D, Maxwell P, Wilkie M, Ong A, Zehnder D, Aldridge N, Adler S, Klein M, Battle D, Bennett W, Berger B, Dell K, Blumenfeld J, Donahue S, Bolin P, Browder R, Perry A, Oskoui F, Culpepper M, Dahl N, Edelstein C, Clegg L, Fischer D, Kaplan M, Kaveh K, Pankhaniya R, Koren M, Mansur K, Lafayette R, Lamar W, Lee J, Mahnensmith R, Nachman P, Mottl A, Miskulin D, Petersen J, Radhakrishnan J, Roppolo M, Basireddy M, Rosner M, Bolton W, Schulman G, Steed L, Steinman T, Hogan M, Venuto R, Turban S, Winklhofer F., Cardiovascular Centre (CVC), Groningen Kidney Center (GKC), Torres, Ve, Chapman, Ab, Devuyst, O, Gansevoort, Rt, Grantham, Jj, Higashihara, E, Perrone, Rd, Krasa, Hb, Ouyang, J, Czerwiec, F, Tempo, Team, Gross, P, Schulze, B, Bichet, D, Chauveau, D, Peeters, P, Voiculescu, M, Manunta, P, Tuazon, J, Watnick, T, Goral, S, Horie, S, Nutahara, K, Torres, V, Chapman, A, Gansevoort, R, Perrone, R, Goldstein, S, Cowley, B, Fukagawa, M, Torra, R, Wei, Lj, Cook, T, Toto, R, Agarwal, R, August, P, Bakris, G, Beddhu, S, Corwin, H, Ruilope, L, Rosa-Diez, G, De La Fuente, J, Martin, R, Massari, P, Novoa, P, Rial, M, Wasserman, A, Faull, R, Fraser, I, Johnson, D, Pedagagos, E, Lian, M, Pollock, C, Cooper, B, Rangan, G, Russ, G, Mcdonald, S, Thomas, M, Khoo, D, Walker, R, Pirson, Y, Laecke, V, Van der Niepen, P, Sennesael, J, Barre, P, Alam, A, Soroka, S, Dieperink, H, Strandgaard, S, Petersen, L, Berthoux, F, Canaud, B, Gontiers-Picard, A, Huart, A, Combe, C, Delmas, Y, Dussol, B, Laville, M, Guebre-Egziabher, F, Mignon, F, Michel, C, Rieu, P, Noel, N, Ryckelynck, J, Lobbedez, T, Dellanna, F, Kleophas, W, Feldkamp, T, Witzke, O, Nurnberger, J, Zeltner, R, Walz, G, Zeier, M, Sommerer, C, Bianchi, S, Capasso, G, Miranda, N, Magistroni, R, Bracale, M, Remuzzi, G, Rota, S, Villa, G, Tilocca, P, Asahi, K, Kato, T, Endo, M, Umezono, T, Fujigaki, Y, Kato, A, Fukatsu, A, Hasegawa, H, Tayama, Y, Hasegawa, M, Hosoya, T, Hanaoka, K, Iehara, N, Iino, Y, Tsuruoka, S, Imai, E, Isaka, Y, Ishimura, E, Ito, S, Sato, H, Kamata, K, Sakamoto, H, Kamura, K, Kusano, E, Muto, S, Kuwahara, M, Matsubara, A, Yorioka, N, Mochizuki, T, Narita, I, Naya, Y, Nihei, N, Yukio, N, Nishio, S, Nitta, K, Tsuchiya, K, Okamura, M, Sasaki, S, Rai, T, Seta, K, Sugawara, A, Shibazaki, S, Sugiyama, S, Tabei, K, Takaichi, K, Tomita, K, Kitamura, K, Tsukamoto, Y, Tsuruya, K, Nakano, T, Ubara, Y, Watanabe, T, Yamamoto, T, Yoshida, K, Ishii, D, Yuzawa, Y, Meijer, E, Vervloet, M, Ciechanowski, K, Wisniewska, M, Gutowska-Jablonska, M, Marcinkowska-Królewicz, M, Klatko, W, Wiśniewski, T, Klinger, M, Krajewska, M, Ksiazek, A, Orłowska, G, Malecki, R, Gontarek-Kacprzak, J, Nowicki, M, Makówka, A, Rutkowski, B, Wołyniec, W, Rydzewski, A, Sulowicz, W, Jasik, P, Covic, A, Volovat, C, Mircescu, G, Petrescu, L, Bobeica, R, Barbarash, O, Chesnokova, L, Borovoy, S, Demina, L, Shostka, G, Idovu, M, Tkalich, L, Geynits, O, Tomilina, N, Foggensteiner, L, Holt, S, Kingswood, J, Lambie, S, Peel, R, Macdougall, I, Tucker, B, Macphee, I, Maxwell, A, Brown, H, Mikhail, A, Bastin, L, Turner, N, Neary, J, Wheeler, D, Maxwell, P, Wilkie, M, Ong, A, Zehnder, D, Aldridge, N, Adler, S, Klein, M, Battle, D, Bennett, W, Berger, B, Dell, K, Blumenfeld, J, Donahue, S, Bolin, P, Browder, R, Perry, A, Oskoui, F, Culpepper, M, Dahl, N, Edelstein, C, Clegg, L, Fischer, D, Kaplan, M, Kaveh, K, Pankhaniya, R, Koren, M, Mansur, K, Lafayette, R, Lamar, W, Lee, J, Mahnensmith, R, Nachman, P, Mottl, A, Miskulin, D, Petersen, J, Radhakrishnan, J, Roppolo, M, Basireddy, M, Rosner, M, Bolton, W, Schulman, G, Steed, L, Steinman, T, Hogan, M, Venuto, R, Turban, S, Winklhofer, F., University of Zurich, Torres, Vicente E, Feldkamp, Thorsten (Beitragende*r), and Witzke, Oliver (Beitragende*r)

Subjects
Male, Tolvaptan, Medizin, 2700 General Medicine, SIROLIMUS, Kidney, V2 RECEPTOR ANTAGONIST, 10052 Institute of Physiology, Aquaretic, VASOPRESSIN V-2-RECEPTOR ANTAGONIST, Polycystic Kidney, 10035 Clinic for Nephrology, Medicine (all), General Medicine, Organ Size, Middle Aged, Adolescent, Adult, Benzazepines, Double-Blind Method, Female, Glomerular Filtration Rate, Humans, Polycystic Kidney, Autosomal Dominant, Sodium, Young Adult, Antidiuretic Hormone Receptor Antagonists, LONG-ACTING SOMATOSTATIN, Autosomal Dominant, 10076 Center for Integrative Human Physiology, OPC-41061, medicine.symptom, medicine.drug, medicine.medical_specialty, RENAL-FUNCTION, CYST GROWTH, Autosomal dominant polycystic kidney disease, Urology, Renal function, Kidney Volume, 610 Medicine & health, Placebo, Article, VOLUME PROGRESSION, Cystic kidney disease, Internal medicine, medicine, HYPONATREMIA, business.industry, urogenital system, ORAL TOLVAPTAN, medicine.disease, Endocrinology, Albuminuria, 570 Life sciences, biology, business
Abstract

BACKGROUND: The course of autosomal dominant polycystic kidney disease (ADPKD) is often associated with pain, hypertension, and kidney failure. Preclinical studies indicated that vasopressin V 2 -receptor antagonists inhibit cyst growth and slow the decline of kidney function. METHODS: In this phase 3, multicenter, double-blind, placebo-controlled, 3-year trial, we randomly assigned 1445 patients, 18 to 50 years of age, who had ADPKD with a total kidney volume of 750 ml or more and an estimated creatinine clearance of 60 ml per minute or more, in a 2:1 ratio to receive tolvaptan, a V 2 -receptor antagonist, at the highest of three twice-daily dose regimens that the patient found tolerable, or placebo. The primary outcome was the annual rate of change in the total kidney volume. Sequential secondary end points included a composite of time to clinical progression (defined as worsening kidney function, kidney pain, hypertension, and albuminuria) and rate of kidney-function decline. RESULTS: Over a 3-year period, the increase in total kidney volume in the tolvaptan group was 2.8% per year (95% confidence interval [CI], 2.5 to 3.1), versus 5.5% per year in the placebo group (95% CI, 5.1 to 6.0; P

Published
2012

38. Erythropoietic response to oral iron in patients with nondialysis-dependent chronic kidney disease in the FIND-CKD trial

Author

Macdougall, I. C., Bock, A. H., Carrera, F., Eckardt, K. -U., Gaillard, C., Van Wyck, D., Meier, Y., Larroque, S., Perrin, A., Roger, S. D., Gilles, Auguste, Faull, R., Toussaint, N. D., Mcmahon, L., Suranyi, M., Mudge, D., Hutchison, B., Irish, A., Kerr, P., Kulkarni, H., Elder, G., Jardine, M., Lhotta, K., Mayer, G., Vanholder, R., Maes, B. D., Evenepoel, P., Debelle, F., Jadoul, M., Dratwa, M., Macel, I., Dunaj, M., Kvapil, M., Bucek, P., Rehorova, J., Hruby, A., Honova, V., Malanova, L., Lucak, M., Lecian, D., Jirovec, M., Vlasak, J., Rychlik, I., Surel, S., Kamper, A. -L., Ostergaard, O., Steffensen, G. K., Chenine, L., Choukroun, G., Zaoui, P., Wanner, C., Backs, W., Kraatz, U., Dellanna, F., Busch, K., Marsen, T., Seeger, W., Woitas, R., Obermueller, N., Haak, T., Lueders, S., Pistrosch, F., Mueller, E., Mertens, P. R., Sutermer, W., Grebe, S. -O., Hafezi-Rachti, S., Roeser, S., Tsakiris, D., Memmos, D., Vlachakos, D., Vargemezis, V., Stefanidis, I., Syrganis, C., Alivanis, P., Papadakis, I., Papagalanis, N., Andrikos, A., Goumenos, D., Siamopoulos, K., Gouva, C., Papadakis, G., Boletis, I., Tsimnadi-Spanoudaki, M., Stamatiades, D., Stamatelou, K., Moutafis, S., Locatelli, Federica, Santoro, A., Quarello, F., Remuzzi, G., Coppola, S., Mortellaro, R. F., Icardi, A., Colussi, G., Grotta, F. D., Lombardi, L., Gallieni, M., Villa, G., Grandaliano, Giuseppe, Huisman, S., Barendregt, J., Gregoor, P. J. H., Oien, C., Rutkowski, B., Malecki, R., Nowicki, M., Rutkowski, P., Marczewski, K., Mysliwiec, M., Sydor, A., Rysz, J., Rydzewski, A., Klinger, M., Wnuk, R., Kozminski, P., Nocon, A., Ciechanowski, K., Correia, P., Neves, F., Barata, J., Mircescu, G., Voiculescu, M., Gluhovschi, G., Mota, E., De Francisco, A. L. M., Torre, A., Herreros, A., Luno, J., Gruss, E., Martins, J., Valles, M., Pascual, J., Barany, P., Ambuehl, P. M., Erturk, S., Arici, M., Paydas, S., Soypacaci, Z., Camsari, T., Ustundag, S., Thomas, M. E., D'Souza, R. J., Taylor, J. E., Pritchard, N. R., Jeffery, R., Riley, S. G., Bhatnagar, D., Bhandari, S., Reaich, D., Stevens, P. E., El Kossi, M., Roe, S., Camilleri, B., Ahmed, A., Khwaja, A., Thompson, B., Banerjee, D., Nicholas, J., Hutchison, A., Borrows, R., and Groningen Kidney Center (GKC)

Subjects
0301 basic medicine, Male, 030232 urology & nephrology, Administration, Oral, Gastroenterology, oral, 0302 clinical medicine, DIALYSIS, nondialysis, Settore MED/14 - NEFROLOGIA, Erythropoiesis, SUCROSE, Aged, 80 and over, education.field_of_study, biology, Anemia, General Medicine, Iron deficiency, RANDOMIZED CONTROLLED-TRIAL, Middle Aged, Nephrology, Female, INTRAVENOUS FERRIC CARBOXYMALTOSE, Research Article, Adult, medicine.medical_specialty, Iron, Population, supplement, 03 medical and health sciences, Multicenter trial, Internal medicine, medicine, DEFICIENCY ANEMIA, Humans, Renal Insufficiency, Chronic, education, Aged, Transferrin saturation, business.industry, ferritin, hemoglobin, medicine.disease, Ferritin, 030104 developmental biology, biology.protein, Hemoglobin, business, Kidney disease
Abstract

Aims: To evaluate erythropoietic response rates to oral iron over time in iron-deficient anemic patients with nondialysis-dependent chronic kidney disease (ND-CKD). Materials and methods: FIND-CKD was a 1-year, randomized, multicenter trial of iron therapy in patients with ND-CKD, anemia, and iron deficiency, without erythropoiesis-stimulating agent (ESA) therapy. Patients with active infection or C-reactive protein > 20 mg/L were excluded. In this post-hoc analysis, response was defined as >= 1 g/dL increase in hemoglobin (Hb) from baseline, before initiation of alternative anemia therapy (i.e., ESA, transfusion, or intravenous iron). Results: 308 patients received oral iron (200 mg elemental iron/day). Mean (SD) Hb at baseline was 10.4 (0.7) g/dL. At week 4, Hb data were available from 292 patients without alternative anemia therapy: 63/292 (21.6%) showed a response. Among the 229 nonresponders at week 4, 48.8% showed a cumulative response on >= 1 occasion by week 52 (11.1%, 19.9%, 25.9%, and 28.7% had a response at weeks 8, 12, 24, and 52, respectively), and 27.9% had received alternative iron therapy by week 52. Baseline levels of Hb, ferritin, and transferrin saturation were lower in responders than in nonresponders. Neither concomitant medication nor adherence (as assessed by medication count) was substantially different between early responders and nonresponders. Conclusion: Four weeks after starting oral iron therapy, only 21.6% of anemic patients with ND-CKD and iron deficiency showed an Hb increase of at least 1 g/dL. Among early nonresponders

Published
2017

39. Bezlotoxumab for Prevention of Recurrent Clostridium difficile Infection

Author

Wilcox, M. H., Gerding, D. N., Poxton, I. R., Kelly, C., Nathan, R., Birch, T., Cornely, O. A., Rahav, G., Bouza, E., Lee, C., Jenkin, G., Jensen, W., Kim, Y. -S., Yoshida, J., Gabryelski, L., Pedley, A., Eves, K., Tipping, R., Guris, D., Kartsonis, N., Playford G, Dorr M. -B., Mcgechie, D, Iredell, J, Allworth, A, Cheng, A, Choi, Nj, Thalhammer, F, Maieron, A, Wenisch, C, Meyer, B, Jacobs, F, Delmee, M, Peetermans, W, Giot, Jb, Munhoz, Al, Kallas, Eg, Ladeira, Jp, Bernstein, Cn, Grimard, D, Mcgeer, A, Poirier, A, Valiquette, L, Miller, M, Oughton, M, Trottier, S, Dolce, P, Smyth, D, Gambra, P, Palma, S, Rojas, L, Northland, R, Arellano, Mc, Perez, J, Barreto, Mf, Gomez, Jm, Ramirez, I, Correa, A, Onate, J, Rohacova, H, Stastnik, M, Zjevikova, A, Blazek, J, Kumpel, P, Petersen, Am, Gluud, Ll, Staugaard, Hm, Tvede, M, Glerup, H, Madsen, Sm, Helms, M, Naumann, R, Karthaus, M, Reinshagen, M, Raz, R, Giladi, M, Chowers, M, Bishara, J, Quirino, T, Castelli, F, Bassetti, M, Rizzardini, G, Vismara, E, Puoti, M, Viale, P, Menichetti, F, Cauda, R, Bonfanti, P, Franzetti, F, Gori, A, Minoli, L, Noriega, Er, Mills, Gd, Ritchie, S, Burns, A, Pithie, A, dos Santos RM, Aldomiro, F, Fernando, Pb, Rola, J, Reis, E, Van Zyl JH, Aboo, N, Richards, G, Hernandez, Mj, de Medrano VA, Prunonosa, Lm, Gonzalez, Jl, Reinoso, Jc, Martinez, Ar, Cisneros, Jd, Banos, Jr, Sheridan, R, Minton, J, Williams, J, Stanley, P, Guleri, A, Llewelyn, M, Todd, N, Barlow, G, Bacon, Ae, Baird, Im, Baxter, R, Zenilman, Jm, Beshay, M, Betts, Rf, Brettholz, Em, Buitrago, Mi, Carlson, Rw, Cook, Pp, Dupont, Hl, Foley, C, Freilich, B, Giron, Ja, Golan, Y, Green, S, Hall, Mc, Johnson, Dj, Jones, Rk, Graham, Dr, Kazimir, M, Keating, M, Brumble, Lm, Kumar, Pn, Liappis, Ap, Libke, R, Mehra, Pk, Overcash, Sj, Mullane, Km, Nguyen, Mh, Patel, Mc, Powers, Ck, Pullman, J, Keegan, J, Nepal, S, English, G, Ricci, Rl, Risi, Gf, Rodriguez, M, Schmitt, Cm, Sims, Md, Kamepalli, R, Tural, A, Vazquez, Ja, Alangaden, Gj, Weavind, Lm, Young, Ma, Chen, St, Liu, E, Nguyen, Hh, Alfonso, Tb, Muse, Dd, Orenstein, R, Yacyshyn, B, Gebhard, Re, Dinges, W, Bolton, M, Rubin, M, Kuemmerle, Jf, Limaye, Ap, Friedenberg, Ka, Hiemenz, Jw, Quadri, A, Martinez, Jv, Barcan, La, Cordova, E, Mykietiuk, A, Losso, M, Fedorak, Rn, Steiner, T, Gerson, M, Weiss, K, Dlouhy, P, Vitous, A, Benes, J, Husa, P, Knizek, P, Anttila, Vj, Broas, M, Camou, F, Postil, D, Launay, O, Corroyer-Simovic, B, Meynard, Jl, Schneider, S, Molina, Jm, Neau, D, Zalcman, G, Boutoille, D, Ostermann, H, Heinz, W, Reuter, S, Oren, I, Schiff, E, Umemoto, T, Masubuchi, T, Mukawa, K, Yasuda, K, Imokawa, S, Fukuda, K, Ohta, H, Harada, N, Fujii, S, Tamaki, S, Yasui, S, Furukawa, K, Takahashi, M, Uraoka, T, Watanabe, M, Ikehara, Y, Kodaira, M, Komatsu, H, Higashi, K, Taguchi, F, Ura, N, Serizawa, Y, Fukuchi, T, Ashikawa, T, Shabana, M, Okubo, M, Matsumoto, M, Kurihara, A, Miyasaka, E, Shimizu, M, Tominaga, H, Kubota, T, Kashiwazaki, M, Masuda, Y, Terasaki, S, Okafuji, H, Mieno, H, Urabe, T, Okamoto, E, Kajimura, M, Yamagishi, Y, Rydzewska, G, Mach, T, Ciechanowski, K, Podlasin, R, Tomasiewicz, K, Janczewska-Kazek, E, Czarnobilski, K, Halota, W, Gryglewska, B, Plesniak, R, Dabrowiecki, P, Lipowski, D, Simanenkov, V, Shcheglova, L, Uspenskiy, Y, Cheganov, A, Han, Ds, Kim, Js, Hong, Sp, Kim, Ti, Jang, Bi, Byeon, Js, Kim, E, Kim, Mj, Lee, J, Pai, H, Cheong, Hj, Lee, S, Loyarte, Ja, Gonzalez, Jc, Santiago, Eb, Lopez, Jr, Baranda, Jm, Viladomiu, As, Calbo, E, Lannergard, A, Falt, J, Gardlund, B, Andersson, Lm, Fraenkel, Cj, Rombo, L, Widmer, A, Chen, Yc, Sheng, Wh, Wang, Fd, Wang, Nc, Lee, Ch, Chen, Yh, Chuang, Yc, Unal, S, Ozaras, R, Esen, S, Ural, O, Ayaz, C, Sakarya, S, Celebi, A, Mistik, R, Bedimo, R, Bressler, A, Mckinley, Mj, Quirk, D, Talansky, Al, Agronin, Me, Akhrass, Fa, Ali, M, Alrabaa, Sf, Assi, Ma, Calfee, Dp, Carson, P, Mariani, Pg, Guerrero, D, Dubberke, Er, Hardi, R, Hazan-Steinberg, S, Itani, Km, Jauregui-Peredo, El, Kasabji, A, Hameed, M, Murillo, A, Odio, Aj, Shah, P, Braun, Ti, Slim, J, Sloan, L, Srinivasan, S, Tan, Mj, Clough, La, Herr, D, Miller, Lg, Dorfmeister, J, Khan, O, and Melik-Abrahamian, F.

Subjects
0301 basic medicine, Male, Adolescent, Adult, Aged, Aged, 80 and over, Anti-Bacterial Agents, Antibodies, Monoclonal, Antibodies, Neutralizing, Clostridium Infections, Double-Blind Method, Drug Therapy, Combination, Female, Humans, Infusions, Intravenous, Intention to Treat Analysis, Kaplan-Meier Estimate, Middle Aged, Secondary Prevention, Young Adult, Clostridium difficile, Clinical Trial, Phase III, Antibiotics, 0302 clinical medicine, Monoclonal, 80 and over, 030212 general & internal medicine, Medicine (all), Neutralizing, education.field_of_study, Research Support, Non-U.S. Gov't, General Medicine, Multicenter Study, Randomized Controlled Trial, Combination, Broadly Neutralizing Antibodies, Intravenous, medicine.medical_specialty, Infusions, medicine.drug_class, 030106 microbiology, Population, Placebo, Antibodies, 03 medical and health sciences, Pharmacotherapy, Drug Therapy, Internal medicine, Journal Article, medicine, education, Intention-to-treat analysis, Clostridioides difficile, business.industry, Interim analysis, Surgery, Bezlotoxumab, business
Abstract

BACKGROUND: Clostridium difficile is the most common cause of infectious diarrhea in hospitalized patients. Recurrences are common after antibiotic therapy. Actoxumab and bezlotoxumab are human monoclonal antibodies against C. difficile toxins A and B, respectively.METHODS: We conducted two double-blind, randomized, placebo-controlled, phase 3 trials, MODIFY I and MODIFY II, involving 2655 adults receiving oral standard-of-care antibiotics for primary or recurrent C. difficile infection. Participants received an infusion of bezlotoxumab (10 mg per kilogram of body weight), actoxumab plus bezlotoxumab (10 mg per kilogram each), or placebo; actoxumab alone (10 mg per kilogram) was given in MODIFY I but discontinued after a planned interim analysis. The primary end point was recurrent infection (new episode after initial clinical cure) within 12 weeks after infusion in the modified intention-to-treat population.RESULTS: In both trials, the rate of recurrent C. difficile infection was significantly lower with bezlotoxumab alone than with placebo (MODIFY I: 17% [67 of 386] vs. 28% [109 of 395]; adjusted difference, -10.1 percentage points; 95% confidence interval [CI], -15.9 to -4.3; PCONCLUSIONS: Among participants receiving antibiotic treatment for primary or recurrent C. difficile infection, bezlotoxumab was associated with a substantially lower rate of recurrent infection than placebo and had a safety profile similar to that of placebo. The addition of actoxumab did not improve efficacy. (Funded by Merck; MODIFY I and MODIFY II ClinicalTrials.gov numbers, NCT01241552 and NCT01513239 .).

Published
2017

42. Novel once-daily extended-release tacrolimus (LCPT) versus twice-daily tacrolimus in de novo kidney transplants: One-year results of phase III, double-blind, randomized trial

Author

Budde, K, Bunnapradist, S, Grinyo, J, Ciechanowski, K, Denny, J, Silva, H, Rostaing, L, Tisone, G, Envarsus study group, and Witzke, Oliver (Beitragende*r)

Subjects
Graft Rejection, Male, Time Factors, immunosuppressant, Medizin, kidney transplantation/nephrology, immunosuppression/immune modulation, Kidney Function Tests, law.invention, Postoperative Complications, Randomized controlled trial, Risk Factors, law, Immunology and Allergy, Pharmacology (medical), Kidney transplantation, Kidney, Graft Survival, clinical trial, Middle Aged, Prognosis, medicine.anatomical_structure, surgical procedures, operative, Female, Extended release, Immunosuppressive Agents, Glomerular Filtration Rate, Adult, medicine.medical_specialty, Urology, clinical research/practice, Drug Administration Schedule, Tacrolimus, calcineurin inhibitor: tacrolimus, Double-Blind Method, medicine, Humans, Adverse effect, Settore MED/14 - Nefrologia, Transplantation, business.industry, medicine.disease, Kidney Transplantation, Surgery, Clinical trial, Kidney Failure, Chronic, Once daily, business, Follow-Up Studies
Abstract

This Phase III randomized trial examined efficacy and safety of a novel once-daily extended-release tacrolimus formulation (LCP-Tacro [LCPT]) versus twice-daily tacrolimus in de novo kidney transplantation. Primary efficacy end point was proportion of patients with treatment failure (death, graft failure, biopsy-proven acute rejection or lost to follow-up) within 12 months. Starting doses were, LCPT: 0.17 mg/kg/day and tacrolimus twice-daily: 0.1 mg/kg/day; 543 patients were randomized, LCPT: n = 268; tacrolimus twice-daily: n = 275. At 12 months treatment failure was LCPT: 18.3% and tacrolimus twice-daily: 19.6%; the upper 95% CI of the treatment difference was +5.27%, below the predefined +10% noninferiority criteria. There were no significant differences in the incidence of individual efficacy events or adverse events. Target tacrolimus trough levels were more rapidly achieved in the LCPT group. Following initial dose, 36.6% of patients in the LCPT group had rapidly attained trough levels within 6-11 ng/mL versus 18.5% of tacrolimus twice-daily patients; majority of tacrolimus twice-daily patients (74.7%) had troughs

Published
2014

45. Prostate-Specific Antigen

Author

Pabisiak, K., primary, Ostrowski, M., additional, Kram, A., additional, Safranow, K., additional, Myślak, M., additional, Sieńko, J., additional, Sulikowski, T., additional, and Ciechanowski, K., additional

Published
2016
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48. Phase 2 randomised trial of oral C5A receptor antagonist CCX168 in ANCA-associated renal vasculitis

Author

UCL - SSS/IREC/NEFR - Pôle de Néphrologie, UCL - (SLuc) Service de néphrologie, Jayne, D. R. W., Bruchfeld, A., Schaier, M., Ciechanowski, K., Harper, L., Jadoul, Michel, Segelmark, M., Selga, D., Szombati, I., Venning, M., Hamilton, P., Hugo, C., Van Daele, P. L. A., Viklicky, O., Potarca, A., Schall, T. J., Bekker, P., 51ST ERA-EDTA CONGRESS, UCL - SSS/IREC/NEFR - Pôle de Néphrologie, UCL - (SLuc) Service de néphrologie, Jayne, D. R. W., Bruchfeld, A., Schaier, M., Ciechanowski, K., Harper, L., Jadoul, Michel, Segelmark, M., Selga, D., Szombati, I., Venning, M., Hamilton, P., Hugo, C., Van Daele, P. L. A., Viklicky, O., Potarca, A., Schall, T. J., Bekker, P., and 51ST ERA-EDTA CONGRESS

Published
2014

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