Trial · NCT03459443
A Proof of Concept Study for a 12 Month Treatment in Patients With C3G or IC-MPGN Treated With ACH-0144471
NCT03459443, Phase 2, Terminated, Alexion Pharmaceuticals, Inc.; results first posted 2022-08-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Proof of Concept Study for a 12 Month Treatment in Patients With C3G or IC-MPGN Treated With ACH-0144471. Trials, record NCT03459443. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03459443
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Proof of Concept Study for a 12 Month Treatment in Patients With C3G or IC-MPGN Treated With ACH-0144471
- NCT number
- NCT03459443
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 22 participants, actual
- Lead sponsor
- Alexion Pharmaceuticals, Inc.
- Conditions
- C3 Glomerulonephritis, C3 Glomerulopathy, Immune Complex Membranoproliferative Glomerulonephritis, IC-MPGN, Dense Deposit Disease
- Interventions
- Danicopan
- First posted
- 2018-03-09
- Last updated
- 2023-08-21
- Other registries' IDs
- eudract:2017-002674-39
- Results first posted
- 2022-08-11
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 End Of Initial 12-Month Treatment Period | Baseline, end of initial 12-Month Treatment Period | 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 the initial 12 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 End Of Initial 12-Month Treatment Period | Baseline, end of initial 12-Month Treatment Period | Proteinuria reduction was defined as ≥30% decrease from baseline based on 24-hour urine protein (mg/day). |
| Secondary | Change From Baseline In Proteinuria At End Of Initial 12-Month Treatment Period | Baseline, end of initial 12-Month Treatment Period | Proteinuria was assessed based on 24-hour urine collections at baseline and end of the initial 12-month Treatment Period. |
| Secondary | Percent Change From Baseline In Proteinuria At End Of Initial 12-Month Treatment Period | Baseline, end of initial 12-Month Treatment Period | Proteinuria was assessed based on 24-hour urine collections at baseline and end of initial 12-month Treatment Period. |
| Secondary | Slope Of Estimated Glomerular Filtration Rate (eGFR) From Baseline To End Of Initial 12-Month Treatment Period | End of initial 12-Month Treatment Period | Slope of eGFR was estimated using a simple linear regression for each participant, including all data values from baseline until the end of the Initial 12-Month Treatment Period, with eGFR as the dependent variable and time as the independent variable. |
| Secondary | Change From Baseline In eGFR At End Of Initial 12-Month Treatment Period | Baseline, end of initial 12-Month Treatment Period | Change from baseline in eGFR at end of initial 12-Month Treatment Period is presented. |
| Secondary | Participants With Significant Improvement In eGFR Relative To Baseline At End Of Initial 12-Month Treatment Period | Baseline, end of initial 12-Month Treatment Period | Significant improvement relative to baseline was defined as a ≥ 25% increase from baseline in eGFR. |
| Secondary | Change From Baseline in eGFR Over 12 Months of Treatment For Participants Meeting eGFR Inclusion Criteria | End of initial 12-Month Treatment Period | Participants were eligible for enrollment if inclusion criteria were met including having an eGFR \>=30 milliliters (mL)/minute (min)/1.73 square meter (m\^2) at the time of screening or at any time over the preceding 4 weeks. This Outcome Measure was registered in case there were participants who were enrolled and ended up not meeting the Eligibility Criteria and was intended to report data for change from baseline in eGFR for only the participants who met the eligibility criteria (that is, participants who did not meet the eligibility criteria would have been excluded from analysis for this Outcome Measure). Since all enrolled participants met the Eligibility Criteria, none of the participants were excluded from this analysis. Therefore, this data is the same data that is presented in Outcome Measure #6 "Change From Baseline In eGFR At End Of Initial 12-Month Treatment Period". Change from baseline in eGFR at end of initial 12-Month Treatment Period is presented. |
| Secondary | Change From Baseline In Measured GFR At The End Of The Initial 12-Month Treatment Period | End of initial 12-Month Treatment Period | Data for this Outcome Measure was to be collected where available. None of the sites collected data for this Outcome Measure. |
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 End Of Initial 12-Month Treatment Period | Baseline, end of initial 12-Month Treatment Period | 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 End Of Initial 12-Month Treatment Period | Baseline, end of initial 12-Month Treatment Period | 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 End Of Initial 12-Month Treatment Period | Baseline, end of initial 12-Month Treatment Period | 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 End Of Initial 12-Month Treatment Period | Baseline, end of initial 12-Month Treatment Period | 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 End Of Initial 12-Month Treatment Period | End of initial 12-Month Treatment Period | 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 End Of Initial 12-Month Treatment Period | Baseline, end of initial 12-Month Treatment Period | 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 End Of Initial 12-Month Treatment Period | Baseline, end of initial 12-Month Treatment Period | 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 eGFR Over 12 Months of Treatment For Participants Meeting eGFR Inclusion Criteria | End of initial 12-Month Treatment Period | 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 | Change From Baseline In Measured GFR At The End Of The Initial 12-Month Treatment Period | End of initial 12-Month Treatment Period | Analysis was not performed, as data were not collected for this Outcome Measure. |
Source ClinicalTrials.gov
Results by group19
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 End Of Initial 12-Month Treatment Period | Danicopan | Baseline | 10.6 | Standard Deviation 3.59 | score on a scale |
| Change From Baseline In Composite Biopsy Score At End Of Initial 12-Month Treatment Period | Danicopan | End of 12-Month Initial Treatment Period | 8.0 | Standard Deviation 4.53 | score on a scale |
| Change From Baseline In Composite Biopsy Score At End Of Initial 12-Month Treatment Period | Danicopan | Change from Baseline | -0.9 | Standard Deviation 1.89 | score on a scale |
| Participants With Reduction In Proteinuria At End Of Initial 12-Month Treatment Period | Danicopan | 8 | participants | ||
| Change From Baseline In Proteinuria At End Of Initial 12-Month Treatment Period | Danicopan | Baseline | 4252.28 | Standard Deviation 2684.959 | mg/day |
| Change From Baseline In Proteinuria At End Of Initial 12-Month Treatment Period | Danicopan | End of Initial 12-Month Treatment Period | 3512.63 | Standard Deviation 3335.765 | mg/day |
| Change From Baseline In Proteinuria At End Of Initial 12-Month Treatment Period | Danicopan | Mean Change from Baseline | -671.11 | Standard Deviation 2695.592 | mg/day |
| Percent Change From Baseline In Proteinuria At End Of Initial 12-Month Treatment Period | Danicopan | -17.1 | Standard Deviation 53.17 | percent change | |
| Slope Of Estimated Glomerular Filtration Rate (eGFR) From Baseline To End Of Initial 12-Month Treatment Period | Danicopan | -1.24917 | Standard Deviation 1.811457 | mL/min/1.73 m^2 per month | |
| Change From Baseline In eGFR At End Of Initial 12-Month Treatment Period | Danicopan | Baseline | 90.692 | Standard Deviation 35.4939 | mL/min/1.73 m^2 |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 results by groupParticipant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Danicopan | 22 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Danicopan | 22 | |
| Overall Study | COMPLETED | Danicopan | 0 | |
| Overall Study | NOT COMPLETED | Danicopan | 22 |
Source ClinicalTrials.gov
Adverse events154
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 | Anaemia | Blood and lymphatic system disorders | Danicopan | 5 | 22 | 5 |
| other | Leukopenia | Blood and lymphatic system disorders | Danicopan | 2 | 22 | 2 |
| other | Thrombocytosis | Blood and lymphatic system disorders | Danicopan | 2 | 22 | 2 |
| other | Anaemia macrocytic | Blood and lymphatic system disorders | Danicopan | 1 | 22 | 1 |
| other | Leukocytosis | Blood and lymphatic system disorders | Danicopan | 1 | 22 | 1 |
| other | Neutrophilia | Blood and lymphatic system disorders | Danicopan | 1 | 22 | 1 |
| other | Palpitations | Cardiac disorders | Danicopan | 2 | 22 | 2 |
| other | Left ventricular failure | Cardiac disorders | Danicopan | 1 | 22 | 1 |
| other | Ear pain | Ear and labyrinth disorders | Danicopan | 2 | 22 | 3 |
| other | Vertigo | Ear and labyrinth disorders | Danicopan | 1 | 22 | 1 |
1 to 10 of 154Source ClinicalTrials.gov
See all 154 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Danicopan | 0 | 22 |
| Total, other adverse events | Danicopan | 22 | 22 |
| Total, serious adverse events | Danicopan | 3 | 22 |
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT03459443
GET https://conductscience.org/api/trials/v1/NCT03459443/events?page=2