Trial · NCT03369236
A Proof-of-Concept Study of Danicopan for 6 Months of Treatment in Participants With C3 Glomerulopathy (C3G)
NCT03369236, Phase 2, Completed, Alexion Pharmaceuticals, Inc.; results first posted 2021-11-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Proof-of-Concept Study of Danicopan for 6 Months of Treatment in Participants With C3 Glomerulopathy (C3G). Trials, record NCT03369236. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03369236
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Proof-of-Concept Study of Danicopan for 6 Months of Treatment in Participants With C3 Glomerulopathy (C3G)
- NCT number
- NCT03369236
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 13 participants, actual
- Lead sponsor
- Alexion Pharmaceuticals, Inc.
- Conditions
- C3 Glomerulopathy, C3 Glomerulonephritis, Dense Deposit Disease
- Interventions
- Danicopan, Placebo
- First posted
- 2017-12-11
- Last updated
- 2022-10-14
- Other registries' IDs
- eudract:2017-000663-33
- Results first posted
- 2021-11-04
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline In Composite Biopsy Score At Week 28 | Baseline, Week 28 | The composite biopsy score was based on a score incorporating changes in the activity index, glomerular C3c staining, and glomerular macrophage infiltration at the end of 6 months of treatment. The composite renal biopsy index scoring system ranged from 0 to 21, with higher scores indicating worse outcomes. |
| Primary | Participants With Reduction In Proteinuria At Week 28 | Week 28 | Proteinuria reduction was defined as ≥ 30% decrease from baseline based on 24-hour urine protein (mg/day). |
| Secondary | Change From Baseline In Proteinuria At Week 28 | Baseline, Week 28 | Proteinuria was assessed based on 24-hour urine collections at baseline and Week 28. |
| Secondary | Percent Change From Baseline In Proteinuria At Week 28 | Baseline, Week 28 | Proteinuria was assessed based on 24-hour urine collections at baseline and Week 28. |
| Secondary | Slope Of Estimated Glomerular Filtration Rate (eGFR) From Baseline To 6 Months | 6 months | Slope of eGFR was estimated using a simple linear regression for each participant, including all data values from baseline until the end of the 6-month blinded treatment period, with eGFR as the dependent variable and time as the independent variable. |
| Secondary | Slope Of Estimated Glomerular Filtration Rate (eGFR) After Open-label Danicopan Treatment | 12 months | Slope of eGFR was estimated using a simple linear regression for each participant, including all data values during the open-label extension period with eGFR as the dependent variable and time as the independent variable. |
| Secondary | Change From Baseline In eGFR At Week 28 | Baseline, Week 28 | Change from baseline in eGFR at Week 28 is presented. |
| Secondary | Participants With Significant Improvement In eGFR Relative To Baseline At Week 28 | Baseline, Week 28 | Significant improvement relative to baseline was defined as a ≥ 20% increase from baseline in eGFR. |
| Secondary | Participants With Significant Improvement In eGFR Relative To Baseline At Week 52 | Baseline, Week 52 | Significant improvement relative to baseline was defined as a ≥ 20% increase from baseline in eGFR. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline In Composite Biopsy Score At Week 28 | Baseline, Week 28 | All participants who received at least 1 dose of study drug and had analyzable data at the specified timepoints. | score on a scale | MEAN |
| PRIMARY | Participants With Reduction In Proteinuria At Week 28 | Week 28 | All participants who received at least 1 dose of study drug and had analyzable data at the specified timepoints. | participants | NUMBER |
| SECONDARY | Change From Baseline In Proteinuria At Week 28 | Baseline, Week 28 | All participants who received at least 1 dose of study drug and had analyzable data at the specified timepoints. | mg/day | MEAN |
| SECONDARY | Percent Change From Baseline In Proteinuria At Week 28 | Baseline, Week 28 | All participants who received at least 1 dose of study drug and had analyzable data at the specified timepoints. | percent change | MEAN |
| SECONDARY | Slope Of Estimated Glomerular Filtration Rate (eGFR) From Baseline To 6 Months | 6 months | All participants who received at least 1 dose of study drug and had analyzable data at the specified timepoints. | mL/min/1.73 m^2 per month | MEAN |
| SECONDARY | Slope Of Estimated Glomerular Filtration Rate (eGFR) After Open-label Danicopan Treatment | 12 months | All participants who received at least 1 dose of study drug and had analyzable data at the specified timepoints. | mL/min/1.73 m^2 per month | MEAN |
| SECONDARY | Change From Baseline In eGFR At Week 28 | Baseline, Week 28 | All participants who received at least 1 dose of study drug and had analyzable data at the specified timepoints. | mL/min/1.73 m^2 | MEAN |
| SECONDARY | Participants With Significant Improvement In eGFR Relative To Baseline At Week 28 | Baseline, Week 28 | All participants who received at least 1 dose of study drug and had analyzable data at the specified timepoints. | participants | NUMBER |
| SECONDARY | Participants With Significant Improvement In eGFR Relative To Baseline At Week 52 | Baseline, Week 52 | All participants who received at least 1 dose of study drug and had analyzable data at the specified timepoints. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group31
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline In Composite Biopsy Score At Week 28 | Danicopan (Double-blind Treatment Period) | Baseline | 11.7 | Standard Deviation 4.23 | score on a scale |
| Change From Baseline In Composite Biopsy Score At Week 28 | Placebo (Double-blind Treatment Period) | Baseline | 9.3 | Standard Deviation 3.50 | score on a scale |
| Change From Baseline In Composite Biopsy Score At Week 28 | Danicopan (Double-blind Treatment Period) | Week 28 | 9.2 | Standard Deviation 4.87 | score on a scale |
| Change From Baseline In Composite Biopsy Score At Week 28 | Placebo (Double-blind Treatment Period) | Week 28 | 10.7 | Standard Deviation 3.39 | score on a scale |
| Change From Baseline In Composite Biopsy Score At Week 28 | Danicopan (Double-blind Treatment Period) | Change from Baseline | -2.0 | Standard Deviation 1.87 | score on a scale |
| Change From Baseline In Composite Biopsy Score At Week 28 | Placebo (Double-blind Treatment Period) | Change from Baseline | 1.3 | Standard Deviation 2.88 | score on a scale |
| Participants With Reduction In Proteinuria At Week 28 | Danicopan (Double-blind Treatment Period) | 0 | participants | ||
| Participants With Reduction In Proteinuria At Week 28 | Placebo (Double-blind Treatment Period) | 1 | participants | ||
| Change From Baseline In Proteinuria At Week 28 | Danicopan (Double-blind Treatment Period) | Baseline | 6137.67 | Standard Deviation 2904.359 | mg/day |
| Change From Baseline In Proteinuria At Week 28 | Placebo (Double-blind Treatment Period) | Baseline | 4274.47 | Standard Deviation 2992.819 | mg/day |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double-blind Treatment Period | STARTED | Danicopan (Double-blind Treatment Period), Followed by Danicopan (Open-label Extension Period) | 6 | |
| Double-blind Treatment Period | STARTED | Placebo (Double-blind Treatment Period), Followed by Danicopan (Open-label Extension Period) | 7 | |
| Double-blind Treatment Period | Received at Least 1 Dose of Study Drug | Danicopan (Double-blind Treatment Period), Followed by Danicopan (Open-label Extension Period) | 6 | |
| Double-blind Treatment Period | Received at Least 1 Dose of Study Drug | Placebo (Double-blind Treatment Period), Followed by Danicopan (Open-label Extension Period) | 7 | |
| Double-blind Treatment Period | COMPLETED | Danicopan (Double-blind Treatment Period), Followed by Danicopan (Open-label Extension Period) | 6 | |
| Double-blind Treatment Period | COMPLETED | Placebo (Double-blind Treatment Period), Followed by Danicopan (Open-label Extension Period) | 6 | |
| Double-blind Treatment Period | NOT COMPLETED | Danicopan (Double-blind Treatment Period), Followed by Danicopan (Open-label Extension Period) | 0 | |
| Double-blind Treatment Period | NOT COMPLETED | Placebo (Double-blind Treatment Period), Followed by Danicopan (Open-label Extension Period) | 1 | |
| Open-label Extension Period | STARTED | Danicopan (Double-blind Treatment Period), Followed by Danicopan (Open-label Extension Period) | 6 | |
| Open-label Extension Period | STARTED | Placebo (Double-blind Treatment Period), Followed by Danicopan (Open-label Extension Period) | 6 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events171
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 | Haematoma | Vascular disorders | Danicopan (Double-blind Treatment Period) | 0 | 6 | |
| other | Haematoma | Vascular disorders | Placebo (Double-blind Treatment Period) | 1 | 7 | |
| other | Haematoma | Vascular disorders | Danicopan (Open-label Extension Period) | 0 | 12 | |
| other | Orthostatic hypotension | Vascular disorders | Danicopan (Double-blind Treatment Period) | 1 | 6 | |
| other | Orthostatic hypotension | Vascular disorders | Placebo (Double-blind Treatment Period) | 0 | 7 | |
| other | Orthostatic hypotension | Vascular disorders | Danicopan (Open-label Extension Period) | 0 | 12 | |
| other | Pallor | Vascular disorders | Danicopan (Double-blind Treatment Period) | 0 | 6 | |
| other | Pallor | Vascular disorders | Placebo (Double-blind Treatment Period) | 1 | 7 | |
| other | Pallor | Vascular disorders | Danicopan (Open-label Extension Period) | 0 | 12 | |
| other | Pregnancy of partner | Social circumstances | Danicopan (Double-blind Treatment Period) | 1 | 6 |
1 to 10 of 171Source ClinicalTrials.gov
See all 171 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Danicopan (Double-blind Treatment Period) | 0 | 6 |
| Total, all-cause mortality | Placebo (Double-blind Treatment Period) | 0 | 7 |
| Total, all-cause mortality | Danicopan (Open-label Extension Period) | 0 | 12 |
| Total, other adverse events | Danicopan (Double-blind Treatment Period) | 5 | 6 |
| Total, other adverse events | Placebo (Double-blind Treatment Period) | 5 | 7 |
| Total, other adverse events | Danicopan (Open-label Extension Period) | 8 | 12 |
| Total, serious adverse events | Danicopan (Double-blind Treatment Period) | 0 | 6 |
| Total, serious adverse events | Placebo (Double-blind Treatment Period) | 0 | 7 |
| Total, serious adverse events | Danicopan (Open-label Extension Period) | 1 | 12 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36423588 | DERIVED |
Source PubMed
Grants0
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.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Danicopan (Double-blind Treatment Period) vs Placebo (Double-blind Treatment Period): Participants With Significant Improvement In eGFR Relative To Baseline At Week 28 | Trial comparisons |
Danicopan (Double-blind Treatment Period), Followed by Danicopan (Open-label Extension Period) vs Placebo (Double-blind Treatment Period), Followed by Danicopan (Open-label Extension Period): Participants With Significant Improvement In eGFR Relative To Baseline At Week 52 | Trial comparisons |
| Danicopan (Double-blind Treatment Period) vs Placebo (Double-blind Treatment Period): Participants With Reduction In Proteinuria At Week 28 | 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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03369236
GET https://conductscience.org/api/trials/v1/NCT03369236/results?page=2