Trial · NCT03301467
Controlled Trial Evaluating Avacopan in C3 Glomerulopathy
NCT03301467, Phase 2, Completed, Amgen; results first posted 2022-10-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Controlled Trial Evaluating Avacopan in C3 Glomerulopathy. Trials, record NCT03301467. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03301467
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Controlled Trial Evaluating Avacopan in C3 Glomerulopathy
- NCT number
- NCT03301467
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 57 participants, actual
- Lead sponsor
- Amgen
- Conditions
- C3 Glomerulopathy (C3G)
- Interventions
- Avacopan, Avacopan Matching Placebo
- First posted
- 2017-10-04
- Last updated
- 2025-03-13
- Results first posted
- 2022-10-14
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline to Week 26 in the C3G Histologic Index for Disease Activity - Subjects With Elevated C5b-9 | 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 |
| Primary | Percent Change From Baseline to Week 26 in the C3G Histologic Index for Disease Activity - Combined C5b-9 Strata | 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. |
| Secondary | 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 | 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 |
| Secondary | 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 | 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 |
| Secondary | Change From Baseline to Week 26 in the C3G Histologic Index for Disease Chronicity - Subjects With Elevated C5b-9 | 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 |
| Secondary | Change From Baseline to Week 26 in the C3G Histologic Index for Disease Chronicity - Combined C5b-9 Strata | 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 |
| Secondary | Renal Function as Assessed by Percent Change From Baseline Over 26 Weeks in eGFR - Subjects With Elevated C5b-9 | 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. |
| Secondary | Renal Function as Assessed by Percent Change From Baseline Over 26 Weeks in eGFR - Combined C5b-9 Strata | 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. |
| Secondary | Renal Function as Assessed by Change From Baseline Over 26 Weeks in eGFR - Subjects With Elevated C5b-9 | 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. |
| Secondary | Renal Function as Assessed by Change From Baseline Over 26 Weeks in eGFR - Combined C5b-9 Strata | 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. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline to Week 26 in the C3G Histologic Index for Disease Activity - Subjects With Elevated C5b-9 | Week 26 | Subjects with Elevated C5b-9 (\> 244 ng/mL) in the Intent-to-Treat (ITT) Population. The number of subjects with data at baseline and the specified visit is reported.~ITT Population: The ITT Population included all randomized subjects who received at least one dose of study medication; subjects with a histologic activity score of 0 at baseline or who were ongoing and had not completed the Week 26 visit were not included in the ITT population. | score on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Percent Change From Baseline to Week 26 in the C3G Histologic Index for Disease Activity - Combined C5b-9 Strata | Week 26 | Combined C5b-9 Strata (elevated \[\> 244 ng/mL\] and non-elevated C5b-9) in the Intent-to-Treat (ITT) Population~ITT Population: The ITT Population included all randomized subjects who received at least one dose of study medication; subjects with a histologic activity score of 0 at baseline or who were ongoing and had not completed the Week 26 visit were not included in the ITT population. | Percentage change | MEAN |
| SECONDARY | 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 | Week 26 | Subjects with Elevated C5b-9 (\> 244 ng/mL) in the Intent-to-Treat (ITT) Population. The number of subjects with C3G Histological Index of Disease Activity Percent Change at Week 26 is reported.~ITT Population: The ITT Population included all randomized subjects who received at least one dose of study medication; subjects with a histologic activity score of 0 at baseline or who were ongoing and had not completed the Week 26 visit were not included in the ITT population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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 | Week 26 | Combined C5b-9 Strata (elevated \[\> 244 ng/mL\] and non-elevated C5b-9) in the Intent-to-Treat (ITT) Population. The number of subjects with C3G Histological Index of Disease Activity Percent Change at Week 26 is reported.~The ITT Population included all randomized subjects who received at least one dose of study medication; subjects with a histologic activity score of 0 at baseline or who were ongoing and had not completed the Week 26 visit were not included in the ITT population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline to Week 26 in the C3G Histologic Index for Disease Chronicity - Subjects With Elevated C5b-9 | Week 26 | Subjects with Elevated C5b-9 (\> 244 ng/mL) in the Intent-to-Treat (ITT) Population. The number of subjects with data at baseline and the specified visit is reported.~ITT Population: The ITT Population included all randomized subjects who received at least one dose of study medication; subjects with a histologic activity score of 0 at baseline or who were ongoing and had not completed the Week 26 visit were not included in the ITT population. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Week 26 in the C3G Histologic Index for Disease Chronicity - Combined C5b-9 Strata | Week 26 | Combined C5b-9 Strata (elevated \[\> 244 ng/mL\] and non-elevated C5b-9) in the Intent-to-Treat (ITT) Population. The number of subjects with data at baseline and the specified visit is reported.~ITT Population: The ITT Population included all randomized subjects who received at least one dose of study medication; subjects with a histologic activity score of 0 at baseline or who were ongoing and had not completed the Week 26 visit were not included in the ITT population. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Renal Function as Assessed by Percent Change From Baseline Over 26 Weeks in eGFR - Subjects With Elevated C5b-9 | Week 26 | Subjects with Elevated C5b-9 (\> 244 ng/mL) in the Intent-to-Treat (ITT) Population. The number of subjects with data at baseline and the specified visit is reported.~ITT Population: The ITT Population included all randomized subjects who received at least one dose of study medication; subjects with a histologic activity score of 0 at baseline or who were ongoing and had not completed the Week 26 visit were not included in the ITT population. | Percentage change | LEAST_SQUARES_MEAN |
| SECONDARY | Renal Function as Assessed by Percent Change From Baseline Over 26 Weeks in eGFR - Combined C5b-9 Strata | Week 26 | Combined C5b-9 Strata (elevated \[\> 244 ng/mL\] and non-elevated C5b-9) in the Intent-to-Treat (ITT) Population. The number of subjects with data at baseline and the specified visit is reported.~ITT Population: The ITT Population included all randomized subjects who received at least one dose of study medication; subjects with a histologic activity score of 0 at baseline or who were ongoing and had not completed the Week 26 visit were not included in the ITT population. | Percentage change | LEAST_SQUARES_MEAN |
| SECONDARY | Renal Function as Assessed by Change From Baseline Over 26 Weeks in eGFR - Subjects With Elevated C5b-9 | Week 26 | Subjects with Elevated C5b-9 (\> 244 ng/mL) in the Intent-to-Treat (ITT) Population. The number of subjects with data at baseline and the specified visit is reported.~ITT Population: The ITT Population included all randomized subjects who received at least one dose of study medication; subjects with a histologic activity score of 0 at baseline or who were ongoing and had not completed the Week 26 visit were not included in the ITT population. | mL/min/1.73m^2 | LEAST_SQUARES_MEAN |
| SECONDARY | Renal Function as Assessed by Change From Baseline Over 26 Weeks in eGFR - Combined C5b-9 Strata | Week 26 | Combined C5b-9 Strata (elevated \[\> 244 ng/mL\] and non-elevated C5b-9) in the Intent-to-Treat (ITT) Population. The number of subjects with data at baseline and the specified visit is reported.~ITT Population: The ITT Population included all randomized subjects who received at least one dose of study medication; subjects with a histologic activity score of 0 at baseline or who were ongoing and had not completed the Week 26 visit were not included in the ITT population. | mL/min/1.73m^2 | LEAST_SQUARES_MEAN |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 outcomesResults by group96
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline to Week 26 in the C3G Histologic Index for Disease Activity - Subjects With Elevated C5b-9 | Placebo Group | -0.9 | 95% Confidence Interval -2.2 to 0.4 | score on a scale | |
| Change From Baseline to Week 26 in the C3G Histologic Index for Disease Activity - Subjects With Elevated C5b-9 | Avacopan Group | -1.0 | 95% Confidence Interval -2.3 to 0.4 | score on a scale | |
| Percent Change From Baseline to Week 26 in the C3G Histologic Index for Disease Activity - Combined C5b-9 Strata | Placebo Group | 26.20 | Standard Error 47.302 | Percentage change | |
| Percent Change From Baseline to Week 26 in the C3G Histologic Index for Disease Activity - Combined C5b-9 Strata | Avacopan Group | -5.77 | Standard Error 5.904 | Percentage change | |
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 | Placebo Group | Responder | 4 | Participants | |
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 | Avacopan Group | Responder | 2 | Participants | |
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 | Placebo Group | Non-Responder | 16 | Participants | |
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 | Avacopan Group | Non-Responder | 16 | Participants | |
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 | Placebo Group | Responder | 7 | Participants | |
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 | Avacopan Group | Responder | 4 | Participants |
1 to 10 of 96Source ClinicalTrials.gov
See all 96 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo Group | 29 | |
| Overall Study | STARTED | Avacopan Group | 28 | |
| Overall Study | COMPLETED | Placebo Group | 25 | |
| Overall Study | COMPLETED | Avacopan Group | 25 | |
| Overall Study | NOT COMPLETED | Placebo Group | 4 | |
| Overall Study | NOT COMPLETED | Avacopan Group | 3 |
Source ClinicalTrials.gov
Adverse events88
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Oedema peripheral | General disorders | Placebo Group | 1 | 29 | 1 |
| other | Oedema peripheral | General disorders | Avacopan Group | 5 | 28 | 6 |
| other | Fatigue | General disorders | Placebo Group | 0 | 29 | 0 |
| other | Fatigue | General disorders | Avacopan Group | 3 | 28 | 3 |
| other | Pyrexia | General disorders | Placebo Group | 2 | 29 | 4 |
| other | Pyrexia | General disorders | Avacopan Group | 0 | 28 | 0 |
| other | Influenza | Infections and infestations | Placebo Group | 1 | 29 | 1 |
| other | Influenza | Infections and infestations | Avacopan Group | 2 | 28 | 2 |
| other | Lower respiratory tract infection | Infections and infestations | Placebo Group | 0 | 29 | 0 |
| other | Lower respiratory tract infection | Infections and infestations | Avacopan Group | 2 | 28 | 2 |
1 to 10 of 88Source ClinicalTrials.gov
See all 88 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo Group | 0 | 29 |
| Total, all-cause mortality | Avacopan Group | 0 | 28 |
| Total, other adverse events | Placebo Group | 24 | 29 |
| Total, other adverse events | Avacopan Group | 25 | 28 |
| Total, serious adverse events | Placebo Group | 3 | 29 |
| Total, serious adverse events | Avacopan Group | 3 | 28 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39392695 | DERIVED |
Source PubMed
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01FD006342 | Phase 2 Study of Avacopan for Treatment of C3G, IND 132321, Orphan Designation 16-5590 | STAEHR, PETER M | CHEMOCENTRYX, INC. | FOOD AND DRUG ADMINISTRATION | 2019 to 2020 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Avacopan Group vs Placebo Group: deaths from any cause | Trial comparisons |
| Avacopan Group vs Placebo Group: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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