Controlled Trial Evaluating Avacopan in C3 Glomerulopathy

Conditions

• C3 Glomerulopathy (C3G)

Eligibility Criteria

Sex

ALL

Age

12 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Avacopan — DRUG
  Orally administered
• Avacopan Matching Placebo — DRUG
  avacopan matching placebo

Study Details

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

Key Dates

Start date

Sep 29, 2017

Status verified

Mar 2025

Primary completion

Mar 3, 2021

Completion

Oct 27, 2021

Study Design

Enrollment

57 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Avacopan
  Avacopan (formerly CCX168) 10 mg capsules x 3 administered twice daily during the blinded 26 week blinded treatment period
• Placebo Comparator: Avacopan Matching Placebo
  Matching placebo capsules x 3 administered twice daily during the 26 week blinded treatment period period

Primary Outcome Measure

Change From Baseline to Week 26 in the C3G Histologic Index for Disease Activity - Subjects With Elevated C5b-9 [ Time Frame: Week 26 ]

Locations (10)

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