Trial · NCT04572854
Study Assessing the Safety and Efficacy of Pegcetacoplan in Post-Transplant Recurrence of C3G or IC-MPGN
NCT04572854, Phase 2, Completed, Apellis Pharmaceuticals, Inc.; results first posted 2025-02-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study Assessing the Safety and Efficacy of Pegcetacoplan in Post-Transplant Recurrence of C3G or IC-MPGN. Trials, record NCT04572854. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04572854
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study Assessing the Safety and Efficacy of Pegcetacoplan in Post-Transplant Recurrence of C3G or IC-MPGN
- NCT number
- NCT04572854
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 13 participants, actual
- Lead sponsor
- Apellis Pharmaceuticals, Inc.
- Conditions
C3G, IC-MPGN, Renal Transplant, Complement 3 Glomerulopathy, Complement 3 Glomerulopathy (C3G), Dense Deposit Disease (DDD), Membranoproliferative Glomerulonephritis, Membranoproliferative Glomerulonephritis (MPGN), Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN), C3 Glomerulopathy, C3 Glomerulonephritis, Complement 3 Glomerulonephritis
- Interventions
- Pegcetacoplan
- First posted
- 2020-10-01
- Last updated
- 2026-04-21
- Results first posted
- 2025-02-07
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Subjects With Reduction in C3c Staining on Renal Biopsy at Week 12 | Baseline (Day 1) and Week 12 | C3c staining intensity is semi quantitatively graded on a scale of 0 to 3, in which negative, 1+, 2+ and 3+ staining corresponds to scores of 0 to 3, with 0 being absent and 3 being the highest intensity seen on immunofluorescence. Higher scores indicate worse outcome. Reduction in C3c staining was defined as decrease of at least 2 orders of magnitude of intensity from baseline. Baseline was defined as the most recent non-missing measurement prior to first administration of study drug for Group 1 subjects or randomization for Group 2 subjects. |
| Secondary | Percentage of Subjects With Reduction in C3c Staining on Renal Biopsy at Week 52 | Baseline (Day 1) and Week 52 | C3c staining intensity is semi quantitatively graded on a scale of 0 to 3, in which negative, 1+, 2+ and 3+ staining corresponds to scores of 0 to 3, with 0 being absent and 3 being the highest intensity seen on immunofluorescence. Higher scores indicate worse outcome. Reduction in C3c staining was defined as decrease of at least 2 orders of magnitude of intensity from baseline. Baseline was defined as the most recent non-missing measurement prior to first administration of study drug for Group 1 subjects or randomization for Group 2 subjects. |
| Secondary | Number of Subjects With Shift of C3c Staining From Baseline to Weeks 12 and 52 | Baseline (Day 1), Week 12 and Week 52 | C3c staining intensity is semi quantitatively graded on a scale of 0 to 3, in which negative, 1+, 2+ and 3+ staining corresponds to scores of 0 to 3, with 0 being absent and 3 being the highest intensity seen on immunofluorescence. Higher scores indicate worse outcome. Baseline was defined as the most recent non-missing measurement prior to first administration of study drug for Group 1 subjects or randomization for Group 2 subjects. Number of subjects who demonstrated a shift of C3c staining from baseline to Week 12 and baseline to Week 52 are presented. |
| Secondary | Percentage of Subjects With Stabilization or Improvement in Estimated Glomerular Filtration Rate (eGFR) at Week 52 | Baseline (Day 1) and Week 52 | eGFR was calculated by using Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) creatinine equation. Stabilization or improvement in eGFR was defined as no more than a 25% decrease relative to baseline. Baseline was defined as the most recent non-missing measurement prior to first administration of study drug for Group 1 subjects or randomization for Group 2 subjects. |
| Secondary | Percentage of Subjects With Stabilization or Improvement of Serum Creatinine Concentration at Week 52 | Baseline (Day 1) and Week 52 | Stabilization or improvement in serum creatinine was defined as no increase or an increase of no more than 25% from baseline. Baseline was defined as the most recent non-missing measurement prior to first administration of study drug for Group 1 subjects or randomization for Group 2 subjects. |
| Secondary | Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 52 | Baseline (Day 1) and Week 52 | Blood samples were collected at specified timepoints for analysis of eGFR which was calculated by using CKD-EPI creatinine equation. Baseline was defined as the most recent non-missing measurement prior to first administration of study drug for Group 1 subjects or randomization for Group 2 subjects. |
| Secondary | Percentage Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 52 | Baseline (Day 1) and Week 52 | Blood samples were collected at specified timepoints for analysis of eGFR which was calculated by using CKD-EPI creatinine equation. Baseline was defined as the most recent non-missing measurement prior to first administration of study drug for Group 1 subjects or randomization for Group 2 subjects. |
| Secondary | Change From Baseline in Serum Creatinine Concentration at Week 52 | Baseline (Day 1) and Week 52 | Blood samples were collected at specified timepoints for analysis of serum creatinine concentration. Baseline was defined as the most recent non-missing measurement prior to first administration of study drug for Group 1 subjects or randomization for Group 2 subjects. |
| Secondary | Percentage Change From Baseline in Serum Creatinine Concentration at Week 52 | Baseline (Day 1) and Week 52 | Blood samples were collected at specified timepoints for analysis of serum creatinine concentration. Baseline was defined as the most recent non-missing measurement prior to first administration of study drug for Group 1 subjects or randomization for Group 2 subjects. |
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 | Percentage of Subjects With Reduction in C3c Staining on Renal Biopsy at Week 12 | Baseline (Day 1) and Week 12 | The ITT population included all subjects who were randomized. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Subjects With Reduction in C3c Staining on Renal Biopsy at Week 52 | Baseline (Day 1) and Week 52 | The ITT population included all subjects who were randomized. | Percentage of participants | NUMBER |
| SECONDARY | Number of Subjects With Shift of C3c Staining From Baseline to Weeks 12 and 52 | Baseline (Day 1), Week 12 and Week 52 | The ITT population included all subjects who were randomized. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Subjects With Stabilization or Improvement in Estimated Glomerular Filtration Rate (eGFR) at Week 52 | Baseline (Day 1) and Week 52 | The ITT population included all subjects who were randomized. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Subjects With Stabilization or Improvement of Serum Creatinine Concentration at Week 52 | Baseline (Day 1) and Week 52 | The ITT population included all subjects who were randomized. | Percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 52 | Baseline (Day 1) and Week 52 | The ITT population included all subjects who were randomized. Only subjects with data collected at baseline and Week 52 are reported. | milliliter/minute/1.73 square meter | MEAN |
| SECONDARY | Percentage Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 52 | Baseline (Day 1) and Week 52 | The ITT population included all subjects who were randomized. Only subjects with data collected at baseline and Week 52 are reported. | percentage change | MEAN |
| SECONDARY | Change From Baseline in Serum Creatinine Concentration at Week 52 | Baseline (Day 1) and Week 52 | The ITT population included all subjects who were randomized. Only subjects with data collected at baseline and Week 52 are reported. | milligram per deciliter | MEAN |
| SECONDARY | Percentage Change From Baseline in Serum Creatinine Concentration at Week 52 | Baseline (Day 1) and Week 52 | The ITT population included all subjects who were randomized. Only subjects with data collected at baseline and Week 52 are reported. | percentage change | MEAN |
Source ClinicalTrials.gov
Results by group32
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Subjects With Reduction in C3c Staining on Renal Biopsy at Week 12 | Part A: Controlled Portion: Group 1 | 50.0 | 95% Confidence Interval 18.7 to 81.3 | Percentage of participants | |
| Percentage of Subjects With Reduction in C3c Staining on Renal Biopsy at Week 12 | Part A: Controlled Portion: Group 2 | 33.3 | 95% Confidence Interval 0.8 to 90.6 | Percentage of participants | |
| Percentage of Subjects With Reduction in C3c Staining on Renal Biopsy at Week 52 | Part A: Non-controlled Portion: Group 1 | 50.0 | 95% Confidence Interval 18.7 to 81.3 | Percentage of participants | |
| Percentage of Subjects With Reduction in C3c Staining on Renal Biopsy at Week 52 | Part A: Non-controlled Portion: Group 2 | 66.7 | 95% Confidence Interval 9.4 to 99.2 | Percentage of participants | |
| Number of Subjects With Shift of C3c Staining From Baseline to Weeks 12 and 52 | Part A: Non-controlled Portion: Group 1 | Shift from 3 at baseline to 0 at Week 12 | 3 | Participants | |
| Number of Subjects With Shift of C3c Staining From Baseline to Weeks 12 and 52 | Part A: Non-controlled Portion: Group 2 | Shift from 3 at baseline to 0 at Week 12 | 0 | Participants | |
| Number of Subjects With Shift of C3c Staining From Baseline to Weeks 12 and 52 | Part A: Non-controlled Portion: Group 1 | Shift from 2 at baseline to 0 at Week 12 | 1 | Participants | |
| Number of Subjects With Shift of C3c Staining From Baseline to Weeks 12 and 52 | Part A: Non-controlled Portion: Group 2 | Shift from 2 at baseline to 0 at Week 12 | 0 | Participants | |
| Number of Subjects With Shift of C3c Staining From Baseline to Weeks 12 and 52 | Part A: Non-controlled Portion: Group 1 | Shift from 3 at baseline to 1 at Week 12 | 1 | Participants | |
| Number of Subjects With Shift of C3c Staining From Baseline to Weeks 12 and 52 | Part A: Non-controlled Portion: Group 2 | Shift from 3 at baseline to 1 at Week 12 | 1 | Participants |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part A: Controlled: Weeks 1 to 12 | STARTED | Part A: Controlled Portion: Group 1 | 10 | |
| Part A: Controlled: Weeks 1 to 12 | STARTED | Part A: Controlled Portion: Group 2 | 3 | |
| Part A: Controlled: Weeks 1 to 12 | STARTED | Part A: Non-controlled Portion: Group 1 | 0 | |
| Part A: Controlled: Weeks 1 to 12 | STARTED | Part A: Non-controlled Portion: Group 2 | 0 | |
| Part A: Controlled: Weeks 1 to 12 | COMPLETED | Part A: Controlled Portion: Group 1 | 10 | |
| Part A: Controlled: Weeks 1 to 12 | COMPLETED | Part A: Controlled Portion: Group 2 | 3 | |
| Part A: Controlled: Weeks 1 to 12 | COMPLETED | Part A: Non-controlled Portion: Group 1 | 0 | |
| Part A: Controlled: Weeks 1 to 12 | COMPLETED | Part A: Non-controlled Portion: Group 2 | 0 | |
| Part A: Controlled: Weeks 1 to 12 | NOT COMPLETED | Part A: Controlled Portion: Group 1 | 0 | |
| Part A: Controlled: Weeks 1 to 12 | NOT COMPLETED | Part A: Controlled Portion: Group 2 | 0 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events300
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 | COVID-19 | Infections and infestations | Part A: Controlled Portion: Group 1 | 2 | 10 | 2 |
| other | COVID-19 | Infections and infestations | Part A: Controlled Portion: Group 2 | 1 | 3 | 1 |
| other | COVID-19 | Infections and infestations | Part A: Non-controlled Portion: Group 1 | 1 | 10 | 1 |
| other | COVID-19 | Infections and infestations | Part A: Non-controlled Portion: Group 2 | 0 | 3 | 0 |
| other | Influenza | Infections and infestations | Part A: Controlled Portion: Group 1 | 1 | 10 | 1 |
| other | Influenza | Infections and infestations | Part A: Controlled Portion: Group 2 | 1 | 3 | 1 |
| other | Influenza | Infections and infestations | Part A: Non-controlled Portion: Group 1 | 0 | 10 | 0 |
| other | Influenza | Infections and infestations | Part A: Non-controlled Portion: Group 2 | 0 | 3 | 0 |
| other | Cytomegalovirus infection reactivation | Infections and infestations | Part A: Controlled Portion: Group 1 | 1 | 10 | 1 |
| other | Cytomegalovirus infection reactivation | Infections and infestations | Part A: Controlled Portion: Group 2 | 0 | 3 | 0 |
1 to 10 of 300Source ClinicalTrials.gov
See all 300 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part A: Controlled Portion: Group 1 | 0 | 10 |
| Total, all-cause mortality | Part A: Controlled Portion: Group 2 | 0 | 3 |
| Total, all-cause mortality | Part A: Non-controlled Portion: Group 1 | 0 | 10 |
| Total, all-cause mortality | Part A: Non-controlled Portion: Group 2 | 0 | 3 |
| Total, other adverse events | Part A: Controlled Portion: Group 1 | 7 | 10 |
| Total, other adverse events | Part A: Controlled Portion: Group 2 | 3 | 3 |
| Total, other adverse events | Part A: Non-controlled Portion: Group 1 | 8 | 10 |
| Total, other adverse events | Part A: Non-controlled Portion: Group 2 | 3 | 3 |
| Total, serious adverse events | Part A: Controlled Portion: Group 1 | 5 | 10 |
| Total, serious adverse events | Part A: Controlled Portion: Group 2 | 0 | 3 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT04572854
GET https://conductscience.org/api/trials/v1/NCT04572854/results?page=2