Evidence map›Paper›PMID 39392695›Full record

Trial reportJournal of the American Society of Nephrology : JASN2025

Safety and Efficacy of Avacopan in Patients with Complement 3 Glomerulopathy: Randomized, Double-Blind Clinical Trial.

Andrew S Bomback, Leal C Herlitz, Priyanka Punit Kedia, Jeffrey Petersen, Huibin Yue, Richard A Lafayette, ACCOLADE Study Group

Abstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of the American Society of Nephrology : JASN, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

25 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Time to move to a cluster-based management of C3G/IC-MPGN.Pediatric nephrology (Berlin, Germany) · 2026
    Article
  3. Review
  4. Article
  5. Review
  6. Article
  7. Article
  8. Article
  9. Review
  10. Article
  11. Review
  12. Review
  13. A Narrative Review of C3 Glomerulopathy: From Pathogenesis to Targeted Therapy.Canadian journal of kidney health and disease · 2026
    Review
  14. Review
  15. Review
  16. Review
  17. Review
  18. Review
  19. Complement System Inhibitors in Nephrology: An Update-Narrative Review.International journal of molecular sciences · 2025
    Review
  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Andrew S BombackDivision of Nephrology, Department of Medicine, Columbia University Irving Medical Center, New York, New York.ORCID 0000-0001-5449-1667
Leal C HerlitzDepartment of Anatomic Pathology, Cleveland Clinic, Cleveland, Ohio.ORCID 0000-0003-2665-8559
Priyanka Punit KediaAmgen, Thousand Oaks, California.
Jeffrey PetersenAmgen, Thousand Oaks, California.ORCID 0009-0004-0222-5294
Huibin YueAmgen, Thousand Oaks, California.
Richard A LafayetteStanford University Medical Center, Stanford, California.ORCID 0000-0003-3906-7934
ACCOLADE Study Group

Funding

ChemoCentryx (Wholly-owned subsidiary of Amgen), FDA's Office of Orphan Products Development R01FD006342FDA HHS R01 FD006342
6 · The paper itself

Abstract

Background: Complement 3 (C3) glomerulopathy is a rare autoimmune disorder characterized by activation of the alternative complement pathway with isolated or dominant complement 3 deposition in glomeruli. Patients with C3 glomerulopathy may develop progressive deterioration in kidney function and kidney failure. Methods: We studied the safety and efficacy of avacopan 30 mg twice daily in patients with C3 glomerulopathy (N=57) with elevated (>244 ng/ml) and normal (≤244 ng/ml) levels of membrane attack complex or terminal complement complex (C5b-9) in a randomized, double-blind, placebo-controlled, phase 2 trial, with kidney biopsies performed prerandomization and at 26 and 52 weeks. The primary outcome was the percent change from baseline to week 26 in C3 Glomerulopathy Histological Index for disease activity. Results: The study was conducted in patients with C3 glomerulopathy, including C3 GN and dense deposit disease. The median study duration was 60.0 weeks (interquartile range, 59.9–61.0). There were no significant differences in the primary outcome between the avacopan and the placebo group—least squares mean treatment difference (95% confidence interval)= −0.0 (−1.9 to 1.8). The secondary measures of efficacy including C3 Glomerulopathy Histological Index for disease chronicity, urine protein:creatinine ratio, and eGFR were not different between treatment groups. The overall incidence and type of adverse events for both treatment groups were comparable. No deaths were reported during the study, and no new safety signals were detected. Conclusions: The primary end point for the study was not met; other clinical effects of avacopan to improve certain key kidney function parameters and slow disease progression were variable and require further evaluation.

Indexed as

Complement C3GlomerulonephritisGlomerulonephritis, MembranoproliferativeAdultAgedComplement Membrane Attack ComplexDouble-Blind MethodFemaleHumansMaleMiddle AgedTreatment OutcomeComplement C3Complement Membrane Attack Complex

Identifiers

PMID39392695
PMCPMC11888959

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.