| Autor: |
Minnie M. Sarwal, Nicole Arceneaux, Jonathan Barratt, Mark D. Stegall, Christine B. Sethna, Debbie S. Gipson, Shadab Ali, Richard J.H. Smith, Matthew C. Pickering, Lindsey Fuller, Brad H. Rovin, Ashley Frazer-Abel, Carla M. Nester, Rasheed Gbadegesin, Fernando C. Fervenza, Gerald B. Appel, Samir V. Parikh, Daniel C. Cattran, Véronique Frémeaux-Bacchi, Cathie Spino, Sanjay Ram, Pierre Ronco, Laura Bailey-Wickins, Paolo Cravedi, Jonathan J. Hogan, Joshua M. Thurman, Laurence H. Beck, John D. Mahan, Marina Vivarelli, Isa Ashoor, Michelle N. Rheault, Elif Erkan, David L. Feldman, Richard J. Quigg, Richard A. Lafayette, Peter S. Heeger, Andrew S. Bomback, Moglie le Quintrec-Donnette, Michelle A. Hladunewich, Christoph Licht, Krzysztof Kiryluk, Howard Trachtman |
| Rok vydání: |
2022 |
| Předmět: |
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| Zdroj: |
American Journal of Kidney Diseases. 79:570-581 |
| ISSN: |
0272-6386 |
| DOI: |
10.1053/j.ajkd.2021.07.025 |
| Popis: |
Blocking the complement system as a therapeutic strategy has been proposed for numerous glomerular diseases but presents a myriad of questions and challenges, not the least of which is demonstrating efficacy and safety. In light of these potential issues and because there are an increasing number of anti-complement therapy trials either planned or underway, the National Kidney Foundation (NKF) facilitated an all-virtual format scientific workshop entitled, "Improving Clinical Trials for Anti-complement Therapies in Complement-mediated Glomerulopathies." Attended by patient representatives and experts in glomerular diseases, complement physiology, and clinical trial design, the aim of this workshop was to develop standards applicable for designing and conducting clinical trials for anti-complement therapies across a wide spectrum of complement-mediated glomerulopathies. Discussions focused on study design, subject risk assessment and mitigation, laboratory measurements and biomarkers to support these studies, and identification of optimal outcome measures to detect benefit, specifically for trials in complement-mediated diseases. This report summarizes the discussions from this workshop and outlines consensus recommendations. |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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