12 and older, any sex, with C3 Glomerulopathy (C3G). Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change From Baseline to Week 26 in the C3G Histologic Index for Disease Activity - Subjects With Elevated C5b-9Primary· Week 26
Change from baseline to Week 26 in the biopsy-based C3G Histologic Index for disease activity - Subjects with Elevated C5b-9 (\> 244 ng/mL) in the Intent-to-Treat Population.
C3G Histological Index for Disease Activity Scores can range from 0 to 21. A decrease indicates improvement.
C3G=C3 glomerulopathy
Group
Value
95% CI
Placebo Group
-0.9
-2.2 – 0.4
Avacopan Group
-1.0
-2.3 – 0.4
Percent Change From Baseline to Week 26 in the C3G Histologic Index for Disease Activity - Combined C5b-9 StrataPrimary· Week 26
Percent change from baseline to Week 26 in the biopsy-based C3G Histologic Index for disease activity - Combined C5b-9 Strata (elevated \[\> 244 ng/mL\] and non-elevated C5b-9) in the Intent-to-Treat Population.
C3G Histological Index for Disease Activity Scores can range from 0 to 21. A decrease indicates improvement.
C3G=C3 glomerulopathy
\* Multiple Imputation: Missing Week 26 values are imputed using the regression method to create 100 complete datasets.
Group
Value
95% CI
Placebo Group
26.20
± 47.302
Avacopan Group
-5.77
± 5.904
Proportion of Subjects Who Have a Histologic Response Defined as a Decrease (Improvement) in the Biopsy-based C3G Histologic Index for Activity of at Least 35% From Baseline to 26 Weeks - Subjects With Elevated C5b-9Secondary· Week 26
Proportion of subjects who have a histologic response defined as a decrease (improvement) in the biopsy-based C3G Histologic Index for activity of at least 35% from baseline to 26 weeks - Subjects with Elevated C5b-9 (\> 244 ng/mL) in the Intent-to-Treat Population.
C3G Histological Index for Disease Activity Scores can range from 0 to 21. A decrease indicates improvement.
C3G=C3 glomerulopathy
Group
Value
95% CI
Placebo Group
4
Avacopan Group
2
Placebo Group
16
Avacopan Group
16
Proportion of Subjects Who Have a Histologic Response Defined as a Decrease (Improvement) in the Biopsy-based C3G Histologic Index for Activity of at Least 35% From Baseline to 26 Weeks - Combined C5b-9 StrataSecondary· Week 26
Proportion of subjects who have a histologic response defined as a decrease (improvement) in the biopsy-based C3G Histologic Index for activity of at least 35% from baseline to 26 weeks - Combined C5b-9 Strata (elevated \[\> 244 ng/mL\] and non-elevated C5b-9) in the Intent-to-Treat Population.
C3G Histological Index for Disease Activity Scores can range from 0 to 21. A decrease indicates improvement.
C3G=C3 glomerulopathy
Responder
Group
Value
95% CI
Placebo Group
7
Avacopan Group
4
Non-Responder
Group
Value
95% CI
Placebo Group
18
Avacopan Group
21
Change From Baseline to Week 26 in the C3G Histologic Index for Disease Chronicity - Subjects With Elevated C5b-9Secondary· Week 26
Change from baseline to Week 26 in the biopsy-based C3G Histologic Index for disease chronicity over the placebo-controlled treatment period - Subjects with Elevated C5b-9 (\> 244 ng/mL) in the Intent-to-Treat Population.
C3G Histological Index for Disease Chronicity Scores can range from 0 to 10. A decrease indicates improvement.
C3G=C3 glomerulopathy
Group
Value
95% CI
Placebo Group
1.5
0.9 – 2.2
Avacopan Group
1.1
0.3 – 1.8
Change From Baseline to Week 26 in the C3G Histologic Index for Disease Chronicity - Combined C5b-9 StrataSecondary· Week 26
Change from baseline to Week 26 in the biopsy-based C3G Histologic Index for disease chronicity over the placebo-controlled treatment period - Combined C5b-9 Strata (elevated \[\> 244 ng/mL\] and non-elevated C5b-9) in the Intent-to-Treat Population.
C3G Histological Index for Disease Chronicity Scores can range from 0 to 10. A decrease indicates improvement.
C3G=C3 glomerulopathy
Group
Value
95% CI
Placebo Group
1.6
1.1 – 2.2
Avacopan Group
0.8
0.2 – 1.4
Renal Function as Assessed by Percent Change From Baseline Over 26 Weeks in eGFR - Subjects With Elevated C5b-9Secondary· Week 26
The percent change from baseline over 26 weeks in estimated Glomerular Filtration Rate (eGFR) - Subjects with Elevated C5b-9 (\> 244 ng/mL) in the Intent-to-Treat Population.
Group
Value
95% CI
Placebo Group
-4.73
-12.29 – 2.83
Avacopan Group
6.11
-1.86 – 14.08
Renal Function as Assessed by Percent Change From Baseline Over 26 Weeks in eGFR - Combined C5b-9 StrataSecondary· Week 26
The percent change from baseline over 26 weeks in estimated Glomerular Filtration Rate (eGFR) - Combined C5b-9 Strata (elevated \[\> 244 ng/mL\] and non-elevated C5b-9) in the Intent-to-Treat Population.
Group
Value
95% CI
Placebo Group
-5.88
-12.32 – 0.56
Avacopan Group
4.79
-1.66 – 11.23
Renal Function as Assessed by Change From Baseline Over 26 Weeks in eGFR - Subjects With Elevated C5b-9Secondary· Week 26
The change from baseline over 26 weeks in estimated Glomerular Filtration Rate (eGFR) - Subjects with Elevated C5b-9 (\> 244 ng/mL) in the Intent-to-Treat Population.
Group
Value
95% CI
Placebo Group
-3.57
-8.43 – 1.29
Avacopan Group
0.44
-4.69 – 5.56
Renal Function as Assessed by Change From Baseline Over 26 Weeks in eGFR - Combined C5b-9 StrataSecondary· Week 26
The change from baseline over 26 weeks in estimated Glomerular Filtration Rate (eGFR) - Combined C5b-9 Strata (elevated \[\> 244 ng/mL\] and non-elevated C5b-9) in the Intent-to-Treat Population.
Group
Value
95% CI
Placebo Group
-3.35
-7.56 – 0.85
Avacopan Group
0.47
-3.75 – 4.68
Percent Change From Baseline Over 26 Weeks in UPCR in Patients With Abnormal UPCR at Baseline - Subjects With Elevated C5b-9Secondary· Week 26
Percent change from baseline Over 26 Weeks in UPCR in patients with Abnormal UPCR at Baseline (\>= 0.15 g/g) - Subjects with Elevated C5b-9 (\> 244 ng/mL) in the Intent-to-Treat Population.
LSM=Least Squares Mean; UPCR = Urine Protein : Creatinine Ratio
Group
Value
95% CI
Placebo Group
-14
-34 – 12
Avacopan Group
-16
-36 – 12
Percent Change From Baseline Over 26 Weeks in UPCR in Patients With Abnormal UPCR at Baseline - Combined C5b-9 StrataSecondary· Week 26
Percent change from baseline Over 26 Weeks in UPCR in patients with Abnormal UPCR at Baseline (\>= 0.15 g/g) - Combined C5b-9 Strata (elevated \[\> 244 ng/mL\] and non-elevated C5b-9) in the Intent-to-Treat Population.
LSM=Least Squares Mean; UPCR = Urine Protein : Creatinine Ratio
Group
Value
95% CI
Placebo Group
-14
-33 – 10
Avacopan Group
-26
-42 – -6
Adverse events — posted to ClinicalTrials.gov
Time frame: From day 1 throughout the study period (day 182/week 26).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07373262 — Avacopan Added to Standard-of-care Therapy in ANCA-associated Vasculitis With Severe Kidney Involvement
· Phase 3
· not yet recruiting
NCT06676579 — Avacopan in Crescentic Immunoglobulin A Nephropathy (IgAN)
· Phase 2
· recruiting
NCT06321601 — Study to Evaluate Avacopan in Combination With a Rituximab or Cyclophosphamide-containing Regimen, in Children From 6 Ye
· Phase 3
· recruiting
NCT06468826 — A Study of Avacopan in Participants With Normal Renal Function and Participants With End-Stage Renal Disease (ESRD)
· Phase 1
· completed
NCT06072482 — A Study to Evaluate Avacopan in Participants With ANCA-associated Vasculitis
· Phase 4
· recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Amgen
Last refreshed: 13 March 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03301467.