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1. Insights on Nefecon®, a Targeted-Release Formulation of Budesonide and Its Selective Immunomodulatory Effects in Patients with IgA Nephropathy

Author

Barratt J, Kristensen J, Pedersen C, and Jerling M

Subjects
drug delivery, biomarkers, pharmacokinetics, galt, Therapeutics. Pharmacology, RM1-950
Abstract

Jonathan Barratt,1 Jens Kristensen,2 Christian Pedersen,2 Markus Jerling3 1College of Life Sciences, University of Leicester, Leicester, UK; 2Calliditas Therapeutics AB, Stockholm, Sweden; 3Markus Jerling Consulting AB, Stockholm, SwedenCorrespondence: Jonathan Barratt, College of Medicine, Biological Sciences and Psychology, University of Leicester, Leicester, UK, Tel +44 0116 258 8043, Email jb81@leicester.ac.ukAbstract: Immunoglobulin A nephropathy (IgAN) is a chronic, immune-mediated kidney disease characterized by the deposition of galactose-deficient immunoglobulin A1 (Gd-IgA1) in the kidneys. Excess Gd-IgA1 production in patients with IgAN is located within the mucosa-associated lymphoid tissue, particularly within the lamina propria in the distal ileum. Nefecon® is a targeted-release formulation of the corticosteroid budesonide, which became the first treatment approved by the US Food and Drug Administration (FDA; brand name, TARPEYO®) and European Medicines Agency (EMA; KINPEYGO®) for patients with primary IgAN at risk of rapid disease progression, after demonstrating clinically significant reduction of proteinuria in an interim analysis of the Phase III NefIgArd trial. After showing a significant reduction in estimated glomerular filtration rate decline in the full 2-year analysis of the trial, Nefecon was granted full approval by the FDA to reduce the loss of kidney function. Nefecon was specifically designed to deliver budesonide to the distal ileum, selectively targeting excess Gd-IgA1 production in the gut-associated lymphoid tissue. In this review, we describe the properties of Nefecon and the evidence to date that confirms its localized treatment effect. We also present unpublished evidence from Phase I trials investigating the pharmacokinetics and cortisol suppression effects of Nefecon in healthy participants. These studies demonstrated that Nefecon has a distinct pharmacokinetic profile from other budesonide products, allowing for targeted, localized action in the distal ileum. When considered alongside existing clinical trial data showing the effect of Nefecon on gut-associated biomarkers, available evidence indicates that Nefecon has a selective immunomodulatory mechanism of action and a direct disease-modifying effect in patients with IgAN, while having low systemic exposure and adverse effects.Keywords: drug delivery, biomarkers, pharmacokinetics, GALT

Published
2024

2. Evidence from the large VALIGA cohort validates the subclassification of focal segmental glomerulosclerosis in IgA nephropathy

Author

Coppo, R., Feehaly, J., Troyanov, S., Cattran, D.C., Cook, H.T., Roberts, I., Radcliffe, John, Russo, M.L., Tesar, V., Maixnerova, D., Lundberg, S., Gesualdo, L., Emma, F., Fuiano, L., Beltrame, G., Rollino, C., Amore, A., Camilla, R., Peruzzi, L., Praga, M., Feriozzi, S., Polci, R., Segoloni, G., Colla, L., Pani, A., Piras, D., Angioi, A., Cancarini, G., Ravera, S., Durlik, M., Moggia, E., Ballarin, J., Di Giulio, S., Pugliese, F., Serriello, I., Caliskan, Y., Sever, M., Kilicaslan, I., Locatelli, F., Del Vecchio, L., Wetzels, J.F.M., Peters, H., Berg, U., Carvalho, F., da Costa Ferreira, A.C., Maggio, M., Wiecek, A., Ots-Rosenberg, M., Magistroni, R., Topaloglu, R., Bilginer, Y., D’Amico, M., Papagianni, K., Stangou, M., Giacchino, F., Goumenos, D., Papasotirious, M., Kalliakmani, P., Gerolymos, M., Galesic, K., Toric, L., Geddes, C., Siamopoulos, K., Balafa, O., Galliani, M., Stratta, P., Quaglia, M., Bergia, R., Cravero, R., Salvadori, M., Cirami, L., Fellstrom, B., Kloster Smerud, H., Ferrario, F., Stellato, T., Egido, J., Martin, C., Floege, J., Eitner, F., Lupo, A., Bernich, P., Menè, P., Morosetti, M., van Kooten, C., Rabelink, T., Reinders, M.E.J., Boria Grinyo, J.M., Cusinato, S., Benozzi, L., Savoldi, S., Licata, C., Mizerska-Wasiak, M., Roszkowska-Blaim, M., Hryszko, T., Klinger, M., Kamińska, D., Krajewska, M., Martina, G., Messuerotti, A., Dal Canton, A., Esposito, C., Migotto, C., Triolo, G., Mariano, F., Pozzi, C., Boero, R., Cambier, A., Bellur, S., Mazzucco, G., Giannakakis, C., Honsova, E., Sundelin, B., Di Palma, A.M., Diomedi-Casadei, F., Gutiérrez, E., Asunis, A.M., Barratt, J., Tardanico, R., Perkowska-Ptasinska, A., Arce Terroba, J., Fortunato, M., Pantzaki, A., Ozluk, Y., Steenbergen, E., Soderberg, M., Riispere, Z., Furci, L., Orhan, D., Kipgen, D., Casartelli, D., Galesic Ljubanovic, D., Gakiopoulou, H., Bertoni, E., Cannata Ortiz, P., Karkoszka, H., Groene, H.J., Stoppacciaro, A., Bajema, I., Bruijn, J., Fulladosa Oliveras, X., Maldyk, J., Ioachim, E., Royal, V., Bellur, Shubha S., Troyanov, Stéphan, Vorobyeva, Olga, Coppo, Rosanna, and Roberts, Ian S.D.

Published
2024
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4. Application of the International IgA Nephropathy Prediction Tool one or two years post-biopsy

Author

Russo, M.L., Troyanov, S., Cook, H.T., Roberts, I., Tesar, V., Maixnerova, D., Lundberg, S., Gesualdo, L., Emma, F., Fuiano, L., Beltrame, G., Rollino, C., Amore, A., Camilla, R., Peruzzi, L., Praga, M., Feriozzi, S., Polci, R., Segoloni, G., Colla, L., Pani, A., Piras, D., Angioi, A., Cancarini, G., Ravera, S., Durlik, M., Moggia, E., Ballarin, J., Di Giulio, S., Pugliese, F., Serriello, I., Caliskan, Y., Sever, M., Kilicaslan, I., Locatelli, F., Del Vecchio, L., Wetzels, J.F.M., Peters, H., Berg, U., Carvalho, F., da Costa Ferreira, A.C., Maggio, M., Wiecek, A., Ots-Rosenberg, M., Magistroni, R., Topaloglu, R., Bilginer, Y., D’Amico, M., Stangou, M., Giacchino, F., Goumenos, D., Papachristou, E., Galesic, K., Geddes, C., Siamopoulos, K., Balafa, O., Galliani, M., Stratta, P., Quaglia, M., Bergia, R., Cravero, R., Salvadori, M., Cirami, L., Fellstrom, B., Smerud, H. Kloster, Ferrario, F., Stellato, T., Egido, J., Martin, C., Floege, J., Eitner, F., Lupo, A., Bernich, P., Menè, P., Morosetti, M., van Kooten, C., Rabelink, T., Reinders, M.E.J., Boria Grinyo, J.M., Cusinato, S., Benozzi, L., Savoldi, S., Licata, C., Mizerska-Wasiak, M., Martina, G., Messuerotti, A., Dal Canton, A., Esposito, C., Migotto, C., Triolo, G., Mariano, F., Pozzi, C., Boero, R., Bellur, S., Mazzucco, G., Giannakakis, C., Honsova, E., Sundelin, B., Di Palma, A.M., Gutiérrez, E., Asunis, A.M., Barratt, J., Tardanico, R., Perkowska-Ptasinska, A., Terroba, J. Arce, Fortunato, M., Pantzaki, A., Ozluk, Y., Steenbergen, E., Soderberg, M., Riispere, Z., Furci, L., Orhan, D., Kipgen, D., Casartelli, D., Ljubanovic, D. Galesic, Gakiopoulou, H., Bertoni, E., Cannata Ortiz, P., Karkoszka, H., Groene, H.J., Stoppacciaro, A., Bajema, I., Bruijn, J., Fulladosa Oliveras, X., Maldyk, J., Ioachim, E., Bavbek, N., Cook, T., Alpers, C., Berthoux, F., Bonsib, S., D’Agati, V., D’Amico, G., Emancipator, S., Emmal, F., Fervenza, F., Florquin, S., Fogo, A., Groene, H., Haas, M., Hill, P., Hogg, R., Hsu, S., Hunley, T., Hladunewich, M., Jennette, C., Joh, K., Julian, B., Kawamura, T., Lai, F., Leung, C., Li, L., Li, P., Liu, Z., Massat, A., Mackinnon, B., Mezzano, S., Schena, F., Tomino, Y., Walker, P., Wang, H., Weening, J., Yoshikawa, N., Zeng, C.-H., Shi, S., Nogi, C., Suzuki, H., Koike, K., Hirano, K., Yokoo, T., Hanai, M., Fukami, K., Takahashi, K., Yuzawa, Y., Niwa, M., Yasuda, Y., Maruyama, S., Ichikawa, D., Suzuki, T., Shirai, S., Fukuda, A., Fujimoto, S., Trimarchi, H., Barbour, Sean J., Coppo, Rosanna, Zhang, Hong, Liu, Zhi-Hong, Suzuki, Yusuke, Matsuzaki, Keiichi, Er, Lee, Reich, Heather N., Barratt, Jonathan, and Cattran, Daniel C.

Published
2022
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6. 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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7. Evidence from the large VALIGA cohort validates the subclassification of focal segmental glomerulosclerosis in IgA nephropathy.

Author

Bellur, Shubha S., primary, Troyanov, Stéphan, additional, Vorobyeva, Olga, additional, Coppo, Rosanna, additional, Roberts, Ian SD., additional, Cattran, D., additional, Cook, H.T., additional, Feehally, J., additional, Peruzzi, L., additional, Tesar, V., additional, Lunberg, S., additional, Gesualdo, L., additional, Emma, F., additional, Praga, M., additional, Feriozzi, S., additional, Pani, A., additional, Cancarini, G., additional, Durlik, M., additional, Moggia, E., additional, Giannakakis, C., additional, Honsova, E., additional, Sundelin, B.B., additional, Di Palma, A.M., additional, Ferrario, F., additional, Gutierrez, E., additional, Asunis, A.M., additional, Barratt, J., additional, Tardanico, R., additional, and Perkowska-Ptasinska, A., additional

Published
2024
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8. Development and testing of an artificial intelligence tool for predicting end-stage kidney disease in patients with immunoglobulin A nephropathy

Author

Tesar, V., Maixnerova, D., Lundberg, S., Gesualdo, L., Emma, F., Fuiano, L., Beltrame, G., Rollino, C., Coppo, R., Amore, A., Camilla, R., Peruzzi, L., Praga, M., Feriozzi, S., Polci, R., Segoloni, G., Colla, L., Pani, A., Angioi, A., Piras, L., Feehally, J., Cancarini, G., Ravera, S., Durlik, M., Moggia, E., Ballarin, J., Di Giulio, S., Pugliese, F., Serriello, I., Caliskan, Y., Sever, M., Kilicaslan, I., Locatelli, F., Del Vecchio, L., Wetzels, J.F.M., Peters, H., Berg, U., Carvalho, F., da Costa Ferreira, A.C., Maggio, M., Wiecek, A., Ots-Rosenberg, M., Magistroni, R., Topaloglu, R., Bilginer, Y., D’Amico, M., Stangou, M., Giacchino, F., Goumenos, D., Papasotiriou, M., Galesic, K., Toric, L., Geddes, C., Siamopoulos, K., Balafa, O., Galliani, M., Stratta, P., Quaglia, M., Bergia, R., Cravero, R., Salvadori, M., Cirami, L., Fellstrom, B., Smerud, H. Kloster, Ferrario, F., Stellato, T., Egido, J., Martin, C., Floege, J., Eitner, F., Rauen, T., Lupo, A., Bernich, P., Menè, P., Morosetti, M., van Kooten, C., Rabelink, T., Reinders, M.E.J., Grinyo, J.M. Boria, Cusinato, S., Benozzi, L., Savoldi, S., Licata, C., Mizerska-Wasiak, M., Roszkowska-Blaim, M., Martina, G., Messuerotti, A., Canton, A. Dal, Esposito, C., Migotto, C., Triolo, G., Mariano, F., Pozzi, C., Boero, R., Mazzucco, Giannakakis, C., Honsova, E., Sundelin, B., Di Palma, A.M., Gutiérrez, E., Asunis, A.M., Barratt, J., Tardanico, R., Perkowska-Ptasinska, A., Terroba, J. Arce, Fortunato, M., Pantzaki, A., Ozluk, Y., Steenbergen, E., Soderberg, M., Riispere, Z., Furci, L., Orhan, D., Kipgen, D., Casartelli, D., GalesicLjubanovic, D., Gakiopoulou, H., Bertoni, E., Ortiz, P. Cannata, Karkoszka, H., Groene, H.J., Stoppacciaro, A., Bajema, I., Bruijn, J., FulladosaOliveras, X., Maldyk, J., Ioachim, E., Abbrescia, Daniela, Kouri, Nikoleta, Stangou, Maria, Papagianni, Aikaterini, Scolari, Francesco, Delbarba, Elisa, Bonomini, Mario, Piscitani, Luca, Stallone, Giovanni, Infante, Barbara, Godeas, Giulia, Madio, Desiree, Biancone, Luigi, Campagna, Marco, Zaza, Gianluigi, Squarzoni, Isabella, Cangemi, Concetta, Schena, Francesco Paolo, Anelli, Vito Walter, Trotta, Joseph, Di Noia, Tommaso, Manno, Carlo, Tripepi, Giovanni, D’Arrigo, Graziella, Chesnaye, Nicholas C., Russo, Maria Luisa, Zoccali, Carmine, Tesar, Vladimir, and Coppo, Rosanna

Published
2021
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9. Accuracy of glomerular filtration rate estimation using creatinine and cystatin C for identifying and monitoring moderate chronic kidney disease: the eGFR-C study

Author

Lamb, EJ, Barratt, J, Brettell, EA, Cockwell, P, Dalton, RN, Deeks, JJ, Eaglestone, G, Pellatt-Higgins, T, Kalra, PA, Khunti, K, Loud, FC, Ottridge, RS, Potter, A, Rowe, C, Scandrett, K, Sitch, AJ, Stevens, PE, Sharpe, CC, Shinkins, B, Smith, A, Sutton, AJ, Taal, MW, Lamb, EJ, Barratt, J, Brettell, EA, Cockwell, P, Dalton, RN, Deeks, JJ, Eaglestone, G, Pellatt-Higgins, T, Kalra, PA, Khunti, K, Loud, FC, Ottridge, RS, Potter, A, Rowe, C, Scandrett, K, Sitch, AJ, Stevens, PE, Sharpe, CC, Shinkins, B, Smith, A, Sutton, AJ, and Taal, MW

Abstract

BACKGROUND: Estimation of glomerular filtration rate using equations based on creatinine is widely used to manage chronic kidney disease. In the UK, the Chronic Kidney Disease Epidemiology Collaboration creatinine equation is recommended. Other published equations using cystatin C, an alternative marker of kidney function, have not gained widespread clinical acceptance. Given higher cost of cystatin C, its clinical utility should be validated before widespread introduction into the NHS. OBJECTIVES: Primary objectives were to: (1) compare accuracy of glomerular filtration rate equations at baseline and longitudinally in people with stage 3 chronic kidney disease, and test whether accuracy is affected by ethnicity, diabetes, albuminuria and other characteristics; (2) establish the reference change value for significant glomerular filtration rate changes; (3) model disease progression; and (4) explore comparative cost-effectiveness of kidney disease monitoring strategies. DESIGN: A longitudinal, prospective study was designed to: (1) assess accuracy of glomerular filtration rate equations at baseline (n = 1167) and their ability to detect change over 3 years (n = 875); (2) model disease progression predictors in 278 individuals who received additional measurements; (3) quantify glomerular filtration rate variability components (n = 20); and (4) develop a measurement model analysis to compare different monitoring strategy costs (n = 875). SETTING: Primary, secondary and tertiary care. PARTICIPANTS: Adults (≥ 18 years) with stage 3 chronic kidney disease. INTERVENTIONS: Estimated glomerular filtration rate using the Chronic Kidney Disease Epidemiology Collaboration and Modification of Diet in Renal Disease equations. MAIN OUTCOME MEASURES: Measured glomerular filtration rate was the reference against which estimating equations were compared with accuracy being expressed as P30 (percentage of values within 30% of reference) and progression (variously defined) studied as s

Published
2024

12. Improving treatment decisions using personalized risk assessment from the International IgA Nephropathy Prediction Tool

Author

Russo, M.L., Troyanov, S., Cook, H.T., Roberts, I., Tesar, V., Maixnerova, D., Lundberg, S., Gesualdo, L., Emma, F., Fuiano, L., Beltrame, G., Rollino, C., Amore, A., Camilla, R., Peruzzi, L., Praga, M., Feriozzi, S., Polci, R., Segoloni, G., Colla, L., Pani, A., Piras, D., Angioi, A., Cancarini, G., Ravera, S., Durlik, M., Moggia, E., Ballarin, J., Di Giulio, S., Pugliese, F., Serriello, I., Caliskan, Y., Sever, M., Kilicaslan, I., Locatelli, F., Del Vecchio, L., Wetzels, J.F.M., Peters, H., Berg, U., Carvalho, F., da Costa Ferreira, A.C., Maggio, M., Wiecek, A., Ots-Rosenberg, M., Magistroni, R., Topaloglu, R., Bilginer, Y., D’Amico, M., Stangou, M., Giacchino, F., Goumenos, D., Kalliakmani, P., Gerolymos, M., Galesic, K., Geddes, C., Siamopoulos, K., Balafa, O., Galliani, M., Stratta, P., Quaglia, M., Bergia, R., Cravero, R., Salvadori, M., Cirami, L., Fellstrom, B., Kloster Smerud, H., Ferrario, F., Stellato, T., Egido, J., Martin, C., Floege, J., Eitner, F., Lupo, A., Bernich, P., Menè, P., Morosetti, M., van Kooten, C., Rabelink, T., Reinders, M.E.J., Boria Grinyo, J.M., Cusinato, S., Benozzi, L., Savoldi, S., Licata, C., Mizerska-Wasiak, M., Martina, G., Messuerotti, A., Dal Canton, A., Esposito, C., Migotto, C., Triolo, G., Mariano, F., Pozzi, C., Boero, R., Bellur, S., Mazzucco, G., Giannakakis, C., Honsova, E., Sundelin, B., Di Palma, A.M., Gutiérrez, E., Asunis, A.M., Barratt, J., Tardanico, R., Perkowska-Ptasinska, A., Arce Terroba, J., Fortunato, M., Pantzaki, A., Ozluk, Y., Steenbergen, E., Soderberg, M., Riispere, Z., Furci, L., Orhan, D., Kipgen, D., Casartelli, D., Galesic Ljubanovic, D., Gakiopoulou, H., Bertoni, E., Cannata Ortiz, P., Karkoszka, H., Groene, H.J., Stoppacciaro, A., Bajema, I., Bruijn, J., Fulladosa Oliveras, X., Maldyk, J., Ioachim, E., Bavbek, N., Cook, T., Alpers, C., Berthoux, F., Bonsib, S., D’Agati, V., D’Amico, G., Emancipator, S., Emmal, F., Fervenza, F., Florquin, S., Fogo, A., Groene, H., Haas, M., Hill, P., Hogg, R., Hsu, S., Hunley, T., Hladunewich, M., Jennette, C., Joh, K., Julian, B., Kawamura, T., Lai, F., Leung, C., Li, L., Li, P., Liu, Z., Massat, A., Mackinnon, B., Mezzano, S., Schena, F., Tomino, Y., Walker, P., Wang, H., Weening, J., Yoshikawa N, N., Zeng, C.-H., Shi, S., Nogi, C., Suzuki, H., Koike, K., Hirano, K., Yokoo, T., Hanai, M., Fukami, K., Takahashi, K., Yuzawa, Y., Niwa, M., Yasuda, Y., Maruyama, S., Ichikawa, D., Suzuki, T., Shirai, S., Fukuda, A., Fujimoto, S., Trimarchi, H., Barbour, Sean J., Canney, Mark, Coppo, Rosanna, Zhang, Hong, Liu, Zhi-Hong, Suzuki, Yusuke, Matsuzaki, Keiichi, Katafuchi, Ritsuko, Induruwage, Dilshani, Er, Lee, Reich, Heather N., Feehally, John, Barratt, Jonathan, and Cattran, Daniel C.

Published
2020
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15. The magnetic state of Yb in Kondo-lattice YbNi2B2C

Author

Boothroyd, A. T., Barratt, J. P., Bonville, P., Canfield, P. C., Murani, A., Wildes, A. R., and Bewley, R. I.

Subjects
Condensed Matter - Strongly Correlated Electrons
Abstract

We report neutron scattering experiments performed to investigate the dynamic magnetic properties of the Kondo-lattice compound YbNi2B2C. The spectrum of magnetic excitations is found to be broad, extending up to at least 150 meV, and contains inelastic peaks centred near 18 meV and 43 meV. At low energies we observe quasielastic scattering with a width Gamma = 2.1 meV. The results suggest a Yb3+ ground state with predominantly localized 4f electrons subject to (i) a crystalline electric field (CEF) potential, and (ii) a Kondo interaction, which at low temperatures is about an order of magnitude smaller than the CEF interaction. From an analysis of the dynamic magnetic response we conclude that the crystalline electric field acting on the Yb ions has a similar anisotropy to that in other RNi2B2C compounds, but is uniformly enhanced by almost a factor of 2. The static and dynamic magnetic properties of YbNi2B2C are found to be reconciled quite well by means of an approximation scheme to the Anderson impurity model, and this procedure also indicates that the effective Kondo interaction varies with temperature due to the crystal field splitting. We discuss the nature of the correlated-electron ground state of YbNi2B2C based on these and other experimental results, and suggest that this compound might be close to a quantum critical point on the non-magnetic side., Comment: Revised version to be published in Phys Rev B

Published
2002
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22. WCN23-0412 EFFECT OF IPTACOPAN ON PROTEINURIA AND COMPLEMENT BIOMARKERS OVER TIME IN IgA NEPHROPATHY

Author

Barratt, J., primary, Rovin, B.H., additional, Zhang, H., additional, Rizk, D.V., additional, Kashihara, N., additional, Maes, B.D., additional, Trimarchi, H., additional, Sprangers, B., additional, Meier, M., additional, Kollins, D., additional, Junge, G., additional, Milojevic, J., additional, Papachristofi, O., additional, and Perkovic, V., additional

Published
2023
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25. WCN23-1175 UPDATED INTERIM RESULTS OF A PHASE 1/2 STUDY OF BION-1301 IN PATIENTS WITH IGA NEPHROPATHY

Author

Barratt, J., primary, Kim, S.G., additional, Agha, I., additional, Kooienga, L., additional, Madan, A., additional, Ruiz-Ramon, P., additional, Thomas, H., additional, Workeneh, B., additional, Narayanan, R., additional, Sorensen, B., additional, Schwartz, B.M., additional, King, A.J., additional, Jones-Burton, C., additional, and Lee, E.Y., additional

Published
2023
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27. Simultaneous targeted amplicon deep sequencing and library preparation for a time and cost-effective universal parasite diagnostic sequencing approach.

Author

Gondard, M, Lane, M, Barratt, J, Talundzic, E, Qvarnstrom, Y, Gondard, M, Lane, M, Barratt, J, Talundzic, E, and Qvarnstrom, Y

Abstract

We recently described a targeted amplicon deep sequencing (TADS) strategy that utilizes a nested PCR targeting the 18S rDNA gene of blood-borne parasites. The assay facilitates selective digestion of host DNA by targeting enzyme restriction sites present in vertebrates but absent in parasites. This enriching of parasite-derived amplicon drastically reduces the proportion of host-derived reads during sequencing and results in the sensitive detection of several clinically important blood parasites including Plasmodium spp., Babesia spp., kinetoplastids, and filarial nematodes. Despite these promising results, high costs and the laborious nature of metagenomics sequencing are prohibitive to the routine use of this assay in most laboratories. We describe and evaluate a new metagenomic approach that utilizes a set of primers modified from our original assay that incorporates Illumina barcodes and adapters during the PCR steps. This modification makes amplicons immediately compatible with sequencing on the Illumina MiSeq platform, removing the need for a separate library preparation, which is expensive and time-consuming. We compared this modified assay to our previous nested TADS assay in terms of preparation speed, limit of detection (LOD), and cost. Our modifications reduced assay turnaround times from 7 to 5 days. The cost decreased from approximately $40 per sample to $11 per sample. The modified assay displayed comparable performance in the detection and differentiation of human-infecting Plasmodium spp., Babesia spp., kinetoplastids, and filarial nematodes in clinical samples. The LOD of this modified approach was determined for malaria parasites and remained similar to that previously reported for our earlier assay (0.58 Plasmodium falciparum parasites/µL of blood). These modifications markedly reduced costs and turnaround times, making the assay more amenable to routine diagnostic applications.

Published
2023

28. Glomerular diseases in pregnancy: pragmatic recommendations for clinical management.

Author

Fakhouri, F., Schwotzer, N., Cabiddu, G., Barratt, J., Legardeur, H., Garovic, V., Orozco-Guillen, A., Wetzels, J., Daugas, E., Moroni, G., Noris, M., Audard, V., Praga, M., Llurba, E., Wuerzner, G., Attini, R., Desseauve, D., Zakharova, E., Luders, C., Wiles, K., Leone, F., Jesudason, S., Costedoat-Chalumeau, N., Kattah, A., Soto-Abraham, V., Karras, A., Prakash, J., Lightstone, L., Ronco, P., Ponticelli, C., Appel, G., Remuzzi, G., Tsatsaris, V., Piccoli, G.B., Fakhouri, F., Schwotzer, N., Cabiddu, G., Barratt, J., Legardeur, H., Garovic, V., Orozco-Guillen, A., Wetzels, J., Daugas, E., Moroni, G., Noris, M., Audard, V., Praga, M., Llurba, E., Wuerzner, G., Attini, R., Desseauve, D., Zakharova, E., Luders, C., Wiles, K., Leone, F., Jesudason, S., Costedoat-Chalumeau, N., Kattah, A., Soto-Abraham, V., Karras, A., Prakash, J., Lightstone, L., Ronco, P., Ponticelli, C., Appel, G., Remuzzi, G., Tsatsaris, V., and Piccoli, G.B.

Abstract

01 februari 2023, Item does not contain fulltext, Our understanding of the various aspects of pregnancy in women with kidney diseases has significantly improved in the last decades. Nevertheless, little is known about specific kidney diseases. Glomerular diseases are not only a frequent cause of chronic kidney disease in young women, but combine many challenges in pregnancy: immunologic diseases, hypertension, proteinuria, and kidney tissue damage. An international working group undertook the review of available current literature and elicited expert opinions on glomerular diseases in pregnancy with the aim to provide pragmatic information for nephrologists according to the present state-of-the-art knowledge. This work also highlights areas of clinical uncertainty and emphasizes the need for further collaborative studies to improve maternal and fetal health.

Published
2023

29. The Patient Voice in Neovascular Age-Related Macular Degeneration: Findings from a Qualitative Study

Author

Talks, SJ, Daien, V, Mitchell, P, Aslam, T, Barratt, J, Biberger, A, Lamoureux, EL, Hirst, C, Sylvanowicz, M, Finger, RP, Talks, SJ, Daien, V, Mitchell, P, Aslam, T, Barratt, J, Biberger, A, Lamoureux, EL, Hirst, C, Sylvanowicz, M, and Finger, RP

Abstract

INTRODUCTION: Visual impairment resulting from diseases such as neovascular age-related macular degeneration (nAMD) may cause behavioural, environmental, psychological, and logistical challenges that could act as barriers to effective uptake and sustainability of treatment with anti-vascular endothelial growth factor agents (anti-VEGFs). Understanding emotions and experiences of patients with nAMD may help inform the determinants of adherence, and could contribute to improvements in ophthalmic outcomes and quality of life. METHODS: Seventeen patients with nAMD receiving anti-VEGF injections were enrolled from three clinics: one each in France (n = 5), Germany (n = 6), and the UK (n = 6). Patients' health information and treatment characteristics were collected. Individual phone interviews were conducted by experienced health care interviewers. Transcripts were analysed thematically. RESULTS: Patients (53% female) had a mean age of 77 years. Bilateral anti-VEGF injections were received by 24% (n = 4); and most (76%, n = 13) were adherent to their treatment. Patient emotions at diagnosis ranged from happiness at learning about the treatment for nAMD to being terrified of receiving an injection in the eye. Most patients mentioned feeling anxious and fearful before their first injection despite receiving reassurance. After the first injection, these feelings and apprehension abated for many, but not all. With the goal of maintaining the best possible vision, few (24%, n = 4) patients reported more than one missed appointment, and most had never considered stopping treatment. No patient reported additional assistance beyond family support; however, many had difficulties with recreational and domestic activities and had developed coping strategies. CONCLUSION: This study provides insights on patients' emotions related to their experience of nAMD and its management, highlighting the varying experiences between individuals. It shows the importance of the patient's voice whe

Published
2023

30. Retrospective evaluation of an integrated molecular-epidemiological approach to cyclosporiasis outbreak investigations - United States, 2021.

Author

Ahart, L, Jacobson, D, Rice, M, Richins, T, Peterson, A, Zheng, Y, Barratt, J, Cama, V, Qvarnstrom, Y, Montgomery, S, Straily, A, Ahart, L, Jacobson, D, Rice, M, Richins, T, Peterson, A, Zheng, Y, Barratt, J, Cama, V, Qvarnstrom, Y, Montgomery, S, and Straily, A

Abstract

Cyclosporiasis results from an infection of the small intestine by Cyclospora parasites after ingestion of contaminated food or water, often leading to gastrointestinal distress. Recent developments in temporally linking genetically related Cyclospora isolates demonstrated effectiveness in supporting epidemiological investigations. We used 'temporal-genetic clusters' (TGCs) to investigate reported cyclosporiasis cases in the United States during the 2021 peak-period (1 May - 31 August 2021). Our approach split 655 genotyped isolates into 55 genetic clusters and 31 TGCs. We linked two large multi-state epidemiological clusters (Epidemiologic Cluster 1 [n = 136 cases, 54 genotyped] and Epidemiologic Cluster 2 [n = 42 cases, 15 genotyped]) to consumption of lettuce varieties; however, product traceback did not identify a specific product for either cluster due to the lack of detailed product information. To evaluate the utility of TGCs, we performed a retrospective case study comparing investigation outcomes of outbreaks first detected using epidemiological methods with those of the same outbreaks had TGCs been used to first detect them. Our study results indicate that adjustments to routine epidemiological approaches could link additional cases to epidemiological clusters of cyclosporiasis. Overall, we show that CDC's integrated genotyping and epidemiological investigations provide valuable insights into cyclosporiasis outbreaks in the United States.

Published
2023

32. Bilan martial des patients traités par roxadustat pour anémie liée à leur maladie rénale chronique : analyse post hoc chez les patients non dialysés ou incidents en dialyse inclus dans quatre études de phase 3

Author

Barratt, J., primary, Dellanna, F., additional, Portoles, J., additional, Choukroun, G., additional, De Nicola, L., additional, Reusch, M., additional, Young, J., additional, Jiletcovici, A., additional, and Dimković, N., additional

Published
2022
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33. Tolérance du roxadustat par rapport aux agents stimulant l’érythropoïèse dans le traitement de l’anémie chez les patients atteints de maladie rénale chronique non dialysés ou incidents en dialyse : analyse groupée de quatre études de phase 3

Author

Barratt, J., primary, Dellanna, F., additional, Portoles, J., additional, Choukroun, G., additional, de Nicola, L., additional, Reusch, M., additional, Young, J., additional, and Dimković, N., additional

Published
2022
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35. Effects of Sacubitril/Valsartan Versus Irbesartan in Patients With Chronic Kidney Disease: A Randomized Double-Blind Trial

Author

Haynes, Richard, Judge, Parminder K., Staplin, Natalie, Herrington, William G., Storey, Benjamin C., Bethel, Angelyn, Bowman, Louise, Brunskill, Nigel, Cockwell, Paul, Hill, Michael, Kalra, Philip A., McMurray, John J.V., Taal, Maarten, Wheeler, David C., Landray, Martin J., Baigent, Colin, Haynes, R., Judge, P.K., Staplin, N., Herrington, W.G., Storey, B.C., Bethel, A., Bowman, L., Brunskill, N., Cockwell, P., Hill, M., Kalra, P.A., McMurray, J.J., Taal, M., Wheeler, D.C., Landray, M.J., Baigent, C., Baigent, C., Haynes, R., Landray, M.J., Dayanandan, R., Baxter, A., Staplin, N., Bethel, A., Bowman, L., Brunskill, N., Cockwell, P., Herrington, W.G., Hill, M., Judge, P.K., Kalra, P.A., Knott, C., McMurray, J.J.V., Murphy, K., Taal, M., Wheeler, D.C., Wheatley, K., Emberson, J., Tomson, C., Roderick, P., Clark, L., Annand, J., Marks, A., Rose, H., Taal, M., Brear, T., Havill, L., McKinnell, J., Melbourne, S., Shardlow, A., Smith, J., Stone, C., Rowe, P., Connor, A., Wooding, J., Taylor, J., Bough, L., Purse, K., Wignall, S., Winter-Goodwin, B., Brunskill, N., Bailey, B., Barratt, J., Bielecka, E., McCartney, M., Hutchison, A., Asari, A., Waring, D., Sajith, R., Walton, H., Mikhail, A., Hilldrup, I., Latif, F., Shrivastava, R., Nicholas, J., Byrne, T., Sandhu, K.S., Tan, B.K., Ward, J., Whistance-Smith, D., Khwaja, A., Jackson, Y., Kawar, B., Middle, J., Sorrell, J., Byrne, C., Brand, S., McHaffie, E., Haynes, R., Crosbie, S., Judge, P.K., Lafferty, K., Ruse, S., Sharples, E., Storey, B.C., Sampson, A., Kirk, A., Lewis, R., Vinall, L., Watkins, L., Williams, F., Cockwell, P., Anderson, N., Dutton, M., Ferro, C., Fifer, L., Smith, S., Stringer, S., Bhandary, N., Alchi, B., Foxton, J., Jones, L., D’Souza, R., Harrison, D., Heddon, S., Wheeler, D.C., Caplin, B., Damian, E., Sobande, T., Davies, S., Edwards, C., Matthews, C., Plaza, M., Reddy, S., Kalra, P.A., Chiu, D., Haydock, L., Kershaw, M., Wilson, C., Vassallo, D., Methven, S., Bowles, J., Collins, E., Dawson, S., Power, A., Kardasz, S., Laven, C., Wroe, C., Eardley, K., Donaldson, D., Tonks, L., Ayub, W., Evans, G., Hewins, S., Fraser, D., Bagshawe, J., Foxwell, D., Williams, A., Border, D., Birch, S., Griffiths, L., Jones, C., McCullough, K., Molyneux, R., and Richardson, D.

Published
2018
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36. Application of the International IgA Nephropathy Prediction Tool one or two years post-biopsy

Author

Barbour, Sean J., primary, Coppo, Rosanna, additional, Zhang, Hong, additional, Liu, Zhi-Hong, additional, Suzuki, Yusuke, additional, Matsuzaki, Keiichi, additional, Er, Lee, additional, Reich, Heather N., additional, Barratt, Jonathan, additional, Cattran, Daniel C., additional, Russo, M.L., additional, Troyanov, S., additional, Cook, H.T., additional, Roberts, I., additional, Tesar, V., additional, Maixnerova, D., additional, Lundberg, S., additional, Gesualdo, L., additional, Emma, F., additional, Fuiano, L., additional, Beltrame, G., additional, Rollino, C., additional, Amore, A., additional, Camilla, R., additional, Peruzzi, L., additional, Praga, M., additional, Feriozzi, S., additional, Polci, R., additional, Segoloni, G., additional, Colla, L., additional, Pani, A., additional, Piras, D., additional, Angioi, A., additional, Cancarini, G., additional, Ravera, S., additional, Durlik, M., additional, Moggia, E., additional, Ballarin, J., additional, Di Giulio, S., additional, Pugliese, F., additional, Serriello, I., additional, Caliskan, Y., additional, Sever, M., additional, Kilicaslan, I., additional, Locatelli, F., additional, Del Vecchio, L., additional, Wetzels, J.F.M., additional, Peters, H., additional, Berg, U., additional, Carvalho, F., additional, da Costa Ferreira, A.C., additional, Maggio, M., additional, Wiecek, A., additional, Ots-Rosenberg, M., additional, Magistroni, R., additional, Topaloglu, R., additional, Bilginer, Y., additional, D’Amico, M., additional, Stangou, M., additional, Giacchino, F., additional, Goumenos, D., additional, Papachristou, E., additional, Galesic, K., additional, Geddes, C., additional, Siamopoulos, K., additional, Balafa, O., additional, Galliani, M., additional, Stratta, P., additional, Quaglia, M., additional, Bergia, R., additional, Cravero, R., additional, Salvadori, M., additional, Cirami, L., additional, Fellstrom, B., additional, Smerud, H. Kloster, additional, Ferrario, F., additional, Stellato, T., additional, Egido, J., additional, Martin, C., additional, Floege, J., additional, Eitner, F., additional, Lupo, A., additional, Bernich, P., additional, Menè, P., additional, Morosetti, M., additional, van Kooten, C., additional, Rabelink, T., additional, Reinders, M.E.J., additional, Boria Grinyo, J.M., additional, Cusinato, S., additional, Benozzi, L., additional, Savoldi, S., additional, Licata, C., additional, Mizerska-Wasiak, M., additional, Martina, G., additional, Messuerotti, A., additional, Dal Canton, A., additional, Esposito, C., additional, Migotto, C., additional, Triolo, G., additional, Mariano, F., additional, Pozzi, C., additional, Boero, R., additional, Bellur, S., additional, Mazzucco, G., additional, Giannakakis, C., additional, Honsova, E., additional, Sundelin, B., additional, Di Palma, A.M., additional, Gutiérrez, E., additional, Asunis, A.M., additional, Barratt, J., additional, Tardanico, R., additional, Perkowska-Ptasinska, A., additional, Terroba, J. Arce, additional, Fortunato, M., additional, Pantzaki, A., additional, Ozluk, Y., additional, Steenbergen, E., additional, Soderberg, M., additional, Riispere, Z., additional, Furci, L., additional, Orhan, D., additional, Kipgen, D., additional, Casartelli, D., additional, Ljubanovic, D. Galesic, additional, Gakiopoulou, H., additional, Bertoni, E., additional, Cannata Ortiz, P., additional, Karkoszka, H., additional, Groene, H.J., additional, Stoppacciaro, A., additional, Bajema, I., additional, Bruijn, J., additional, Fulladosa Oliveras, X., additional, Maldyk, J., additional, Ioachim, E., additional, Bavbek, N., additional, Cook, T., additional, Alpers, C., additional, Berthoux, F., additional, Bonsib, S., additional, D’Agati, V., additional, D’Amico, G., additional, Emancipator, S., additional, Emmal, F., additional, Fervenza, F., additional, Florquin, S., additional, Fogo, A., additional, Groene, H., additional, Haas, M., additional, Hill, P., additional, Hogg, R., additional, Hsu, S., additional, Hunley, T., additional, Hladunewich, M., additional, Jennette, C., additional, Joh, K., additional, Julian, B., additional, Kawamura, T., additional, Lai, F., additional, Leung, C., additional, Li, L., additional, Li, P., additional, Liu, Z., additional, Massat, A., additional, Mackinnon, B., additional, Mezzano, S., additional, Schena, F., additional, Tomino, Y., additional, Walker, P., additional, Wang, H., additional, Weening, J., additional, Yoshikawa, N., additional, Zeng, C.-H., additional, Shi, S., additional, Nogi, C., additional, Suzuki, H., additional, Koike, K., additional, Hirano, K., additional, Yokoo, T., additional, Hanai, M., additional, Fukami, K., additional, Takahashi, K., additional, Yuzawa, Y., additional, Niwa, M., additional, Yasuda, Y., additional, Maruyama, S., additional, Ichikawa, D., additional, Suzuki, T., additional, Shirai, S., additional, Fukuda, A., additional, Fujimoto, S., additional, and Trimarchi, H., additional

Published
2022
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37. POS-045 Evaluating BCX9930, an Oral Factor D Inhibitor for Treatment of Complement-Mediated Kidney Disease: A Proof-of-Concept Study (RENEW)

Author

Nester, C., primary, Nast, C., additional, Appel, G., additional, Barratt, J., additional, Fervenza, F., additional, Fremeaux-Bacchi, V., additional, Remuzzi, G., additional, Rovin, B., additional, Wong, E., additional, Bourne, E., additional, Marinucci, L., additional, Grayson, D., additional, Patel, R., additional, and Sheridan, W., additional

Published
2022
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38. Magnetic Excitations in YbNi2B2C

Author

Boothroyd, A. T., Barratt, J. P., Lister, S. J. S., Wildes, A. R., Canfield, P. C., Bewley, R. I., Müller, Karl-Hartmut, editor, and Narozhnyi, Vladimir, editor

Published
2001
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39. Bestimmung der Risikofaktoren für die Nicht-Adhärenz und Nicht-Persistenz zu einer Therapie mit antivaskulären endothelialen Wachstumsfaktoren bei nAMD, diabetischer Retinopathie und DME: Eine länderübergreifende Befragung von Patienten und Krankenhausärzten

Author

Ziemssen, F, Wong, D, Wong, T, Barratt, J, Connelly, C, Eldem, B, Finger, R, Loewenstein, A, Sylvanowicz, M, Rodriguez, F, Ziemssen, F, Wong, D, Wong, T, Barratt, J, Connelly, C, Eldem, B, Finger, R, Loewenstein, A, Sylvanowicz, M, and Rodriguez, F

Published
2022

40. Application of the International IgA Nephropathy Prediction Tool one or two years post-biopsy

Author

Barbour, S.J., Coppo, R., Zhang, H, Liu, Zhang, Suzuki, Y., Matsuzaki, K., Er, L., Reich, H.N., Wetzels, J.F.M., Steenbergen, E., Barratt, J., Cattran, D.C., Barbour, S.J., Coppo, R., Zhang, H, Liu, Zhang, Suzuki, Y., Matsuzaki, K., Er, L., Reich, H.N., Wetzels, J.F.M., Steenbergen, E., Barratt, J., and Cattran, D.C.

Abstract

Contains fulltext : 252055.pdf (Publisher’s version ) (Open Access), The International IgA Nephropathy (IgAN) Prediction Tool is the preferred method in the 2021 KDIGO guidelines to predict, at the time of kidney biopsy, the risk of a 50% drop in estimated glomerular filtration rate or kidney failure. However, it is not known if the Prediction Tool can be accurately applied after a period of observation post-biopsy. Using an international multi-ethnic derivation cohort of 2,507 adults with IgAN, we updated the Prediction Tool for use one year after biopsy, and externally validated this in a cohort of 722 adults. The original Prediction Tool applied at one-year without modification had a coefficient of variation (R(2)) of 55% and 54% and four-year concordance (C statistic) of 0.82 but poor calibration with under-prediction of risk (integrated calibration index (ICI) 1.54 and 2.11, with and without race, respectively). Our updated Prediction Tool had a better model fit with higher R(2) (61% and 60%), significant increase in four-year C-statistic (0.87 and 0.86) and better four-year calibration with lower ICI (0.75 and 0.35). On external validation, the updated Prediction Tool had similar R(2) (60% and 58%) and four-year C-statistics (both 0.85) compared to the derivation analysis, with excellent four-year calibration (ICI 0.62 and 0.56). This updated Prediction Tool had similar prediction performance when used two years after biopsy. Thus, the original Prediction Tool should be used only at the time of biopsy whereas our updated Prediction Tool can be used for risk stratification one or two years post-biopsy.

Published
2022

41. Genotyping Cyclospora cayetanensis from multiple outbreak clusters with an emphasis on a cluster linked to bagged salad mix - United States, 2020.

Author

Barratt, J, Ahart, L, Rice, M, Houghton, K, Richins, T, Cama, V, Arrowood, M, Qvarnstrom, Y, Straily, A, Barratt, J, Ahart, L, Rice, M, Houghton, K, Richins, T, Cama, V, Arrowood, M, Qvarnstrom, Y, and Straily, A

Abstract

Cyclosporiasis is a diarrheal illness caused by the food-borne parasite Cyclospora cayetanensis. Annually reported cases have been increasing in the United States prompting development of genotyping tools to aid cluster detection. A recently developed Cyclospora genotyping system based on eight genetic markers was applied to clinical samples collected during the cyclosporiasis peak-period of 2020, facilitating assessment of its epidemiologic utility. While the system performed well and helped inform epidemiological investigations, inclusion of additional markers to improve cluster detection was supported. Consequently, investigations have commenced to identify additional markers to enhance performance.

Published
2022

42. Assessing an Adaptation of the Universal Parasite Diagnostic Assay for Bloodborne Parasites in a US State Public Health Laboratory.

Author

Clemons, B, Barratt, J, Lane, M, Qvarnstrom, Y, Teal, AE, Zayas, G, Madison-Antenucci, S, Clemons, B, Barratt, J, Lane, M, Qvarnstrom, Y, Teal, AE, Zayas, G, and Madison-Antenucci, S

Abstract

For complex clinical cases where a parasitic infection is suspected, it can be difficult for clinicians to recommend an appropriate laboratory test. These tests are usually pathogen-specific and require a certain degree of suspicion for the precise etiology. Recently, Flaherty et al. (2021) described an assay, the universal parasite diagnostic (UPDx) that can potentially provide a diagnosis of any parasite present in a specimen. Using primers that amplify DNA from all eukaryotes, UPDx differentiates several parasitic infections in blood by amplicon-based next-generation sequencing (NGS) of the 18S rDNA locus. As the state's public health reference laboratory, the Parasitology Laboratory at the Wadsworth Center (New York, NY) receives specimens from patients who have potentially encountered a wide variety of parasites. As such, the ability to differentiate several blood parasites using a single assay is of interest. We assessed UPDx for its ability to confirm parasitic infections for 20 specimens that were previously identified by real-time PCR (RT-PCR). This included specimens positive for Babesia microti, Trypanosoma cruzi, Leishmania tropica, various Plasmodium species, and specimens comprising mixed Plasmodium sp. infections. Results obtained using UPDx were largely concordant with the RT-PCR assays. A T. cruzi positive specimen was negative by UPDx and for two mixed Plasmodium sp. infections only one species was detected. The results obtained for other specimens were concordant. We conclude that UPDx shows promise for the detection of blood parasites in diagnostic laboratories. As NGS becomes cheaper, assays like UPDx will become increasingly amenable to use in clinical settings.

Published
2022

45. Is there long-term value of pathology scoring in immunoglobulin A nephropathy? A validation study of the Oxford Classification for IgA Nephropathy (VALIGA) update

Author

Coppo, R., D'Arrigo, G., Tripepi, G., Russo, M. L., Roberts, I. S. D., Bellur, S., Cattran, D., Cook, T. H., Feehally, J., Tesar, V., Maixnerova, D., Peruzzi, L., Amore, A., Lundberg, S., Di Palma, A. M., Gesualdo, L., Emma, F., Rollino, C., Praga, M., Biancone, L., Pani, A., Feriozzi, S., Polci, R., Barratt, J., Del Vecchio, L., Locatelli, F., Pierucci, A., Caliskan, Y., Perkowska-Ptasinska, A., Durlik, M., Moggia, E., Ballarin, J. C., Wetzels, J. F. M., Goumenos, D., Papasotiriou, M., Galesic, K., Toric, L., Papagianni, A., Stangou, M., Benozzi, L., Cusinato, S., Berg, U., Topaloglu, R., Maggio, M., Ots-Rosenberg, M., D'Amico, M., Geddes, C., Balafa, O., Quaglia, M., Cravero, R., Cirami, C. L., Fellstrom, B., Floege, J., Egido, J., Mallamaci, F., Zoccali, C., Fuiano, L., Beltrame, G., Camilla, R., Segoloni, G., Colla, L., Angioi, A., Piras, L., Cancarini, G., Ravera, S., Ballarin, J., Di Giulio, S., Pugliese, F., Serriello, I., Sever, M., Kilicaslan, I., Peters, H., Carvalho, F., Da Costa Ferreira, A. C., Wiecek, A., Magistroni, R., Bilginer, Y., Giacchino, F., Papastirou, M., Siamopoulos, K., Galliani, M., Stratta, P., Bergia, R., Salvadori, M., Cirami, L., Kloster Smerud, H., Ferrario, F., Stellato, T., Martin, C., Eitner, F., Rauen, T., Lupo, A., Bernich, P., Mene, P., Morosetti, M., Van Kooten, C., Rabelink, T., Reinders, M. E. J., Boria Grinyo, J. M., Savoldi, S., Licata, C., Mizerska-Wasiak, M., Roszkowska-Blaim, M., Martina, G., Messuerotti, A., Dal Canton, A., Esposito, C., Migotto, C., Triolo, G., Mariano, F., Pozzi, C., Boero, R., Mazzucco, G., Giannakakis, C., Honsova, E., Sundelin, B., Gutierrez, E., Asunis, A. M., Tardanico, R., Arce Terroba, J., Fortunato, M., Pantzaki, A., Ozluk, Y., Steenbergen, E., Soderberg, M., Riispere, Z., Furci, L., Orhan, D., Kipgen, D., Casartelli, D., Galesic Ljubanovic, D., Akiopoulou, H., Bertoni, E., Cannata Ortiz, P., Karkoszka, H., Groene, H. J., Stoppacciaro, A., Bajema, I., Bruijn, J., Fulladosa Oliveras, X., Maldyk, J., Ioachim, E., and Internal Medicine

Subjects
Adult, Male, Pathology, medicine.medical_specialty, Adolescent, 030232 urology & nephrology, Renal function, 030204 cardiovascular system & hematology, Kidney, Nephropathy, Cohort Studies, 03 medical and health sciences, Glomerulonephritis, 0302 clinical medicine, renal biopsy, Interquartile range, IgA nephropathy, progression, risk factors, Child, Disease Progression, Female, Follow-Up Studies, Glomerular Filtration Rate, Glomerulonephritis, IGA, Humans, Prognosis, Medicine, Endocapillary hypercellularity, IGA, Transplantation, medicine.diagnostic_test, business.industry, medicine.disease, medicine.anatomical_structure, Renal pathology, Nephrology, Cohort, Renal biopsy, Renal disorders Radboud Institute for Health Sciences [Radboudumc 11], business
Abstract

Background It is unknown whether renal pathology lesions in immunoglobulin A nephropathy (IgAN) correlate with renal outcomes over decades of follow-up. Methods In 1130 patients of the original Validation Study of the Oxford Classification for IgA Nephropathy (VALIGA) cohort, we studied the relationship between the MEST score (mesangial hypercellularity, M; endocapillary hypercellularity, E; segmental glomerulosclerosis, S; tubular atrophy/interstitial fibrosis, T), crescents (C) and other histological lesions with both a combined renal endpoint [50% estimated glomerular filtration rate (eGFR) loss or kidney failure] and the rate of eGFR decline over a follow-up period extending to 35 years [median 7 years (interquartile range 4.1–10.8)]. Results In this extended analysis, M1, S1 and T1–T2 lesions as well as the whole MEST score were independently related with the combined endpoint (P Conclusion Long-term follow-up analyses of the VALIGA cohort showed that the independent relationship between kidney biopsy findings and the risk of progression towards kidney failure in IgAN remains unchanged across all age groups and decades after the renal biopsy.

Published
2020

46. POS-546 EFFICACY AND SAFETY OF IPTACOPAN IN IgA NEPHROPATHY: RESULTS OF A RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROLLED PHASE 2 STUDY AT 6 MONTHS

Author

Barratt, J., primary, Rovin, B., additional, Zhang, H., additional, Kashihara, N., additional, Maes, B., additional, Rizk, D., additional, Trimarchi, H., additional, Sprangers, B., additional, Meier, M., additional, Kollins, D., additional, Wang, W., additional, Magirr, A., additional, and Perkovic, V., additional

Published
2022
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50. POS-109 INTERIM RESULTS OF PHASE 1 AND 2 TRIALS TO INVESTIGATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND CLINICAL ACTIVITY OF BION-1301 IN PATIENTS WITH IgA NEPHROPATHY

Author

Barratt, J., primary, Hour, B., additional, Kooienga, L., additional, Roy, S., additional, Schwartz, B., additional, Siddiqui, A., additional, Tolentino, J., additional, IYER, S.P., additional, Stromatt, C., additional, Endsley, A., additional, Lo, J., additional, and Glicklich, A., additional

Published
2022
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