NCT03301467

Controlled Trial Evaluating Avacopan in C3 Glomerulopathy

A Randomized, Double Blind, Placebo Controlled Phase 2 Study to Evaluate the Safety and Efficacy of Avacopan (CCX168) in Patients With C3 Glomerulopathy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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

Detailed description

C3 glomerulopathy (C3G) is characterized by evidence of alternative complement activation based on C3 deposition in the glomeruli. There are two forms of the disease: dense deposit disease (DDD) and C3 glomerulonephritis (C3GN). There is no approved treatment for patients with C3G. This is a randomized, double blind, placebo controlled Phase 2 study to evaluate the safety and efficacy of avacopan (CCX168) in patients with C3G. Patients receive avacopan 30mg or matching placebo orally twice-daily. The placebo-controlled treatment period is 26 weeks (182 days). This will be followed by 26 weeks during which time all patients will receive avacopan (results for this second period will be reported in due course in a follow-up publication). Thereafter, all patients will be followed for eight weeks (56 days) without study drug treatment. The primary objective is to evaluate the efficacy of avacopan compared to placebo based on histologic changes in kidney biopsies taken at baseline and after 26 weeks of treatment. The primary endpoint will be based on the percent change from baseline in the C3G Histologic Index for disease activity. Study acquired by Amgen and all disclosures were done by previous sponsor ChemoCentryx.

Conditions

• C3 Glomerulopathy (C3G)

Interventions

Type	Name	Description
DRUG	Avacopan	Orally administered
DRUG	Avacopan Matching Placebo	avacopan matching placebo

Timeline

• Start date: 2017-09-29
• Primary completion: 2021-03-03
• Completion: 2021-10-27
• First posted: 2017-10-04
• Last updated: 2025-03-13
• Results posted: 2022-10-14

Locations

45 sites across 11 countries: United States, Belgium, Canada, Denmark, France, Germany, Ireland, Italy, Netherlands, Spain, United Kingdom

Regulatory

• FDA-regulated drug study