Controlled Trial Evaluating Avacopan in C3 Glomerulopathy

Phase 2 Completed 57 enrolled Amgen Medpace, Inc. · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The aim of this trial is to evaluate the effect of avacopan treatment on renal disease activity in patients with complement component 3 glomerulopathy (C3G). Funding Source - FDA OOPD

Timeline

Start: 2017-09-29
Primary completion: 2021-03-03
Completion: 2021-10-27

Outcome

Missed primary endpoint

paper There were no significant differences in the primary outcome between the avacopan and the placebo group PMID 39392695 ↗

paper The primary end point for the study was not met PMID 39392695 ↗

Publications

Bomback AS, Herlitz LC, Kedia PP, Petersen J, Yue H, Lafayette RA; ACCOLADE Study Group. Safety and Efficacy of Avacopan in Patients with Complement 3 Glomerulopathy: Randomized, Double-Blind Clinical Trial. J Am Soc Nephrol. 2025 Mar 1;36(3):487-499. doi: 10.1681/ASN.0000000526. Epub 2024 Oct 11.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Avacopan	Small molecule	30 mg	Oral