Journal article
Improving Clinical Trials for Anticomplement Therapies in Complement-Mediated Glomerulopathies: Report of a Scientific Workshop Sponsored by the National Kidney Foundation
American journal of kidney diseases, Vol.79(4), pp.570-581
04/2022
DOI: 10.1053/j.ajkd.2021.07.025
PMID: 34571062
Abstract
Blocking the complement system as a therapeutic strategy has been proposed for numerous glomerular diseases but presents myriad 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 anticomplement therapy trials either planned or under way, the National Kidney Foundation facilitated an all-virtual 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 anticomplement therapies across a wide spectrum of complement-mediated glomerulopathies. Discussions focused on study design, participant 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.
Details
- Title: Subtitle
- Improving Clinical Trials for Anticomplement Therapies in Complement-Mediated Glomerulopathies: Report of a Scientific Workshop Sponsored by the National Kidney Foundation
- Creators
- Andrew S Bomback - Columbia UniversityGerald B Appel - Columbia UniversityDebbie S Gipson - University of Michigan–Ann ArborMichelle A Hladunewich - Sunnybrook Health Science CentreRichard Lafayette - Stanford UniversityCarla M Nester - University of IowaSamir V Parikh - The Ohio State UniversityRichard J.H Smith - University of IowaHoward Trachtman - New York UniversityPeter S Heeger - Icahn School of Medicine at Mount SinaiSanjay Ram - University of Massachusetts Chan Medical SchoolBrad H Rovin - The Ohio State UniversityShadab Ali - National Kidney FoundationNicole Arceneaux - National Kidney FoundationIsa Ashoor - Louisiana State UniversityLaura Bailey-Wickins - National Kidney FoundationJonathan Barratt - University of LeicesterLaurence Beck - Boston UniversityDaniel C Cattran - University of TorontoPaolo Cravedi - Icahn School of Medicine at Mount SinaiElif Erkan - Cincinnati Children's Hospital Medical CenterFernando Fervenza - Mayo ClinicAshley A Frazer-Abel - University of Colorado DenverVeronique Fremeaux-Bacchi - Université Paris CitéLindsey Fuller - National Kidney FoundationRasheed Gbadegesin - Duke UniversityJonathan J Hogan - University of PennsylvaniaKrzysztof Kiryluk - Columbia UniversityMoglie le Quintrec-Donnette - Université de MontpellierChristoph Licht - University of TorontoJohn D Mahan - The Ohio State UniversityMatthew C Pickering - Imperial College LondonRichard Quigg - University at Buffalo, State University of New YorkMichelle Rheault - University of MinnesotaPierre Ronco - Sorbonne UniversitéMinnie M Sarwal - University of California, San FranciscoChristine Sethna - Hofstra UniversityCathie Spino - University of Michigan–Ann ArborMark Stegall - Mayo ClinicMarina Vivarelli - Boston Children's HospitalDavid L Feldman - National Kidney FoundationJoshua M Thurman - University of Colorado Denver
- Resource Type
- Journal article
- Publication Details
- American journal of kidney diseases, Vol.79(4), pp.570-581
- Publisher
- Elsevier Inc
- DOI
- 10.1053/j.ajkd.2021.07.025
- PMID
- 34571062
- ISSN
- 0272-6386
- eISSN
- 1523-6838
- Language
- English
- Date published
- 04/2022
- Academic Unit
- Roy J. Carver Department of Biomedical Engineering; Molecular Physiology and Biophysics; Anatomy and Cell Biology; Nephrology, Dialysis and Transplantation; Stead Family Department of Pediatrics; Iowa Neuroscience Institute; Otolaryngology; Internal Medicine
- Record Identifier
- 9984256837802771
Metrics
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