Trial · NCT05067127
Phase III Study Assessing the Efficacy and Safety of Pegcetacoplan in Patients With C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis
NCT05067127, Phase 3, Completed, Apellis Pharmaceuticals, Inc.; results first posted 2025-08-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Phase III Study Assessing the Efficacy and Safety of Pegcetacoplan in Patients With C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis. Trials, record NCT05067127. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05067127
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase III Study Assessing the Efficacy and Safety of Pegcetacoplan in Patients With C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis
- NCT number
- NCT05067127
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 124 participants, actual
- Lead sponsor
- Apellis Pharmaceuticals, Inc.
- Conditions
C3G, IC-MPGN, C3 Glomerulopathy, C3 Glomerulonephritis, Complement 3 Glomerulopathy, Complement 3 Glomerulopathy (C3G), Complement 3 Glomerulonephritis, Dense Deposit Disease, DDD, Membranoproliferative Glomerulonephritis, Membranoproliferative Glomerulonephritis (MPGN), Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN)
- Interventions
- Pegcetacoplan, Placebo
- First posted
- 2021-10-05
- Last updated
- 2026-01-29
- Results first posted
- 2025-08-06
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Randomized Controlled Period: Change From Baseline in Log-Transformed Urine Protein-to-Creatinine Ratio (uPCR) at Week 26 | Baseline (Day -70 to Day 1) to Week 26 | Baseline uPCR value was calculated as the average of the uPCR measurements from at least 6 of the 9 first-morning spot urine (FMU) samples collected between the start of screening and Day 1, inclusive. The uPCR values used to calculate baseline included those from the samples collected on Day -2, Day -1, and before dosing on Day 1. In situations where less than 6 samples or more than 9 samples were collected, the average of all collected samples was used for baseline derivation. The difference between treatment groups using a composite contrast of equal-weighted average over Weeks 24, 25, and 26 was estimated. |
| Secondary | Randomized Controlled Period: Percentage of Subjects Who Achieved the Composite Renal Endpoint at Week 26 | Week 26 | Subject who achieved a composite renal endpoint was defined as: (1) a stable or improved estimated glomerular filtration rate (eGFR) compared to baseline (\<=15% reduction in eGFR), and (2) a \>=50% reduction in uPCR compared to baseline. Percentages are rounded off to the hundredth decimal place. |
| Secondary | Randomized Controlled Period: Percentage of Subjects With a Reduction of At Least 50% From Baseline in Urine Protein-to-Creatinine Ratio at Week 26 | Baseline (Day -70 to Day 1) and Week 26 | Baseline uPCR value was calculated as the average of the uPCR measurements from at least 6 of the 9 FMU samples collected between the start of screening and Day 1, inclusive. The uPCR values used to calculate baseline included those from the samples collected on Day -2, Day -1, and before dosing on Day 1. In situations where less than 6 samples or more than 9 samples were collected, the average of all collected samples was used for baseline derivation. Percentages are rounded off to the hundredth decimal place. |
| Secondary | Randomized Controlled Period: Change From Baseline in the C3 Glomerulopathy (C3G) Histologic Index Activity Score at Week 26 | Baseline (Day 1) and Week 26 | The C3G histologic index used to assess disease activity and chronicity in C3G. The C3G total activity score ranges from 0 (worse) to 21 (best). Higher scores indicate better outcome. Baseline was defined as the most recent non-missing measurement prior to taking the first dose of study drug. |
| Secondary | Randomized Controlled Period: Percentage of Subjects Who Showed Decrease in C3c Staining on Renal Biopsy From Baseline at Week 26 | Baseline (Day 1) and Week 26 | Subject who showed decrease in C3c staining was defined as decrease of at least 2 orders of magnitude of intensity from baseline. Percentages are rounded off to the hundredth decimal place. |
| Secondary | Randomized Controlled Period: Change From Baseline in Estimated Glomerular Filtration Rate at Week 26 | Baseline (Day 1) and Week 26 | Serum samples were collected to determine the eGFR, calculated by using chronic kidney disease-epidemiology collaboration (CKD-EPI) creatinine equation for adults and the Bedside Schwartz equation for adolescents. Baseline eGFR value was calculated using the last non-missing assessment prior to first dose of study drug. |
| Secondary | Randomized Controlled Period: Percentage of Subjects Who Achieved Proteinuria <1 Gram (g)/Day at Week 24 | Week 24 | Urine samples were collected to determine the proteinuria. Percentage of subjects who achieved proteinuria \<1 g/day was assessed by 24-hour urine protein. Percentages are rounded off to the hundredth decimal place. |
| Secondary | Randomized Controlled Period: Percentage of Subjects With Normalization of Serum Albumin Levels at Week 26 | Week 26 | Baseline serum albumin value was calculated as the average of up to 2 serum albumin measurements preceding and including Day 1. Week 26 serum albumin values was calculated as the average of up to 2 serum albumin measurements preceding and including Week 26, no earlier than Week 20 measurement. Percentages are rounded off to the hundredth decimal place. |
| Secondary | Randomized Controlled Period: Percentage of Subjects With Serum C3 Levels Above the Lower Limit of Normal at Week 26 | Week 26 | Baseline serum C3 value was calculated as the average of up to 2 serum C3 measurements preceding and including Day 1. Week 26 serum C3 value was calculated as the average of up to 2 serum C3 measurements preceding and including Week 26, no earlier than Week 20 measurement. Percentages are rounded off to the hundredth decimal place. |
| Secondary | Randomized Controlled Period: Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 26 | Baseline (Day 1) and Week 26 | The FACIT-Fatigue scale was a 13-item Likert scaled instrument that was self-administered by subjects. Subjects were presented with 13 statements and asked to indicate their responses as it applied to the past 7 days. The 5 possible responses were "not at all" (0), "a little bit" (1), "somewhat" (2), "quite a bit" (3) and "very much" (4). With 13 statements the total score has a range of 0 (worse health-related quality of life) to 52 (best health-related quality of life). Higher scores indicate better quality of life. Baseline was defined as the most recent non-missing measurement prior to taking the first dose of study drug. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Randomized Controlled Period: Change From Baseline in Log-Transformed Urine Protein-to-Creatinine Ratio (uPCR) at Week 26 | Baseline (Day -70 to Day 1) to Week 26 | The ITT analysis set included all randomized subjects. | log (uPCR) | LEAST_SQUARES_MEAN |
| SECONDARY | Randomized Controlled Period: Percentage of Subjects Who Achieved the Composite Renal Endpoint at Week 26 | Week 26 | The ITT analysis set included all randomized subjects. | percentage of subjects | NUMBER |
| SECONDARY | Randomized Controlled Period: Percentage of Subjects With a Reduction of At Least 50% From Baseline in Urine Protein-to-Creatinine Ratio at Week 26 | Baseline (Day -70 to Day 1) and Week 26 | The ITT analysis set included all randomized subjects. | percentage of subjects | NUMBER |
| SECONDARY | Randomized Controlled Period: Change From Baseline in the C3 Glomerulopathy (C3G) Histologic Index Activity Score at Week 26 | Baseline (Day 1) and Week 26 | The ITT analysis set included all randomized subjects. Since adolescents subjects were not required to provide post-screening biopsies, this endpoint was analyzed based on adult subjects only. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Randomized Controlled Period: Percentage of Subjects Who Showed Decrease in C3c Staining on Renal Biopsy From Baseline at Week 26 | Baseline (Day 1) and Week 26 | The ITT analysis set included all randomized subjects. Since adolescents subjects were not required to provide post-screening biopsies, this endpoint was analyzed based on adult subjects only. | percentage of subjects | NUMBER |
| SECONDARY | Randomized Controlled Period: Change From Baseline in Estimated Glomerular Filtration Rate at Week 26 | Baseline (Day 1) and Week 26 | The ITT analysis set included all randomized subjects. | milliliter (mL)/minute/1.73 m^2 | LEAST_SQUARES_MEAN |
| SECONDARY | Randomized Controlled Period: Percentage of Subjects Who Achieved Proteinuria <1 Gram (g)/Day at Week 24 | Week 24 | The ITT analysis set included all randomized subjects. | percentage of subjects | NUMBER |
| SECONDARY | Randomized Controlled Period: Percentage of Subjects With Normalization of Serum Albumin Levels at Week 26 | Week 26 | The ITT analysis set included all randomized subjects. Only subjects with serum albumin levels below lower limit of normal (LLN) at baseline are analyzed. | percentage of subjects | NUMBER |
| SECONDARY | Randomized Controlled Period: Percentage of Subjects With Serum C3 Levels Above the Lower Limit of Normal at Week 26 | Week 26 | The ITT analysis set included all randomized subjects. Only subjects with serum C3 levels below LLN at baseline are analyzed. | percentage of subjects | NUMBER |
| SECONDARY | Randomized Controlled Period: Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 26 | Baseline (Day 1) and Week 26 | The ITT analysis set included all randomized subjects. | units on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Randomized Controlled Period: Change From Baseline in Log-Transformed Urine Protein-to-Creatinine Ratio (uPCR) at Week 26 | Randomized Controlled Period: Pegcetacoplan | -1.114 | 95% Confidence Interval -1.380 to -0.848 | log (uPCR) | |
| Randomized Controlled Period: Change From Baseline in Log-Transformed Urine Protein-to-Creatinine Ratio (uPCR) at Week 26 | Randomized Controlled Period: Placebo | 0.029 | 95% Confidence Interval -0.090 to 0.148 | log (uPCR) | |
| Randomized Controlled Period: Percentage of Subjects Who Achieved the Composite Renal Endpoint at Week 26 | Randomized Controlled Period: Pegcetacoplan | 49.21 | percentage of subjects | ||
| Randomized Controlled Period: Percentage of Subjects Who Achieved the Composite Renal Endpoint at Week 26 | Randomized Controlled Period: Placebo | 3.28 | percentage of subjects | ||
| Randomized Controlled Period: Percentage of Subjects With a Reduction of At Least 50% From Baseline in Urine Protein-to-Creatinine Ratio at Week 26 | Randomized Controlled Period: Pegcetacoplan | 60.32 | percentage of subjects | ||
| Randomized Controlled Period: Percentage of Subjects With a Reduction of At Least 50% From Baseline in Urine Protein-to-Creatinine Ratio at Week 26 | Randomized Controlled Period: Placebo | 4.92 | percentage of subjects | ||
| Randomized Controlled Period: Change From Baseline in the C3 Glomerulopathy (C3G) Histologic Index Activity Score at Week 26 | Randomized Controlled Period: Pegcetacoplan | -3.482 | 95% Confidence Interval -4.721 to -2.244 | units on a scale | |
| Randomized Controlled Period: Change From Baseline in the C3 Glomerulopathy (C3G) Histologic Index Activity Score at Week 26 | Randomized Controlled Period: Placebo | -2.480 | 95% Confidence Interval -3.775 to -1.186 | units on a scale | |
| Randomized Controlled Period: Percentage of Subjects Who Showed Decrease in C3c Staining on Renal Biopsy From Baseline at Week 26 | Randomized Controlled Period: Pegcetacoplan | 74.29 | percentage of subjects | ||
| Randomized Controlled Period: Percentage of Subjects Who Showed Decrease in C3c Staining on Renal Biopsy From Baseline at Week 26 | Randomized Controlled Period: Placebo | 11.76 | percentage of subjects |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Randomized Controlled Period (26 weeks) | STARTED | Randomized Controlled Period: Pegcetacoplan | 63 | |
| Randomized Controlled Period (26 weeks) | STARTED | Randomized Controlled Period: Placebo | 61 | |
| Randomized Controlled Period (26 weeks) | STARTED | Open-Label Period: Pegcetacoplan to Pegcetacoplan | 0 | |
| Randomized Controlled Period (26 weeks) | STARTED | Open-Label Period: Placebo to Pegcetacoplan | 0 | |
| Randomized Controlled Period (26 weeks) | COMPLETED | Randomized Controlled Period: Pegcetacoplan | 61 | |
| Randomized Controlled Period (26 weeks) | COMPLETED | Randomized Controlled Period: Placebo | 57 | |
| Randomized Controlled Period (26 weeks) | COMPLETED | Open-Label Period: Pegcetacoplan to Pegcetacoplan | 0 | |
| Randomized Controlled Period (26 weeks) | COMPLETED | Open-Label Period: Placebo to Pegcetacoplan | 0 | |
| Randomized Controlled Period (26 weeks) | NOT COMPLETED | Randomized Controlled Period: Pegcetacoplan | 2 | |
| Randomized Controlled Period (26 weeks) | NOT COMPLETED | Randomized Controlled Period: Placebo | 4 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events224
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 | Randomized Controlled Period: Pegcetacoplan | 0 | 63 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Randomized Controlled Period: Placebo | 4 | 61 | 4 |
| other | Anaemia | Blood and lymphatic system disorders | Open-Label Period: Pegcetacoplan to Pegcetacoplan | 5 | 61 | 5 |
| other | Anaemia | Blood and lymphatic system disorders | Open-Label Period: Placebo to Pegcetacoplan | 4 | 57 | 4 |
| other | Abdominal pain | Gastrointestinal disorders | Randomized Controlled Period: Pegcetacoplan | 4 | 63 | 6 |
| other | Abdominal pain | Gastrointestinal disorders | Randomized Controlled Period: Placebo | 4 | 61 | 5 |
| other | Abdominal pain | Gastrointestinal disorders | Open-Label Period: Pegcetacoplan to Pegcetacoplan | 2 | 61 | 2 |
| other | Abdominal pain | Gastrointestinal disorders | Open-Label Period: Placebo to Pegcetacoplan | 3 | 57 | 3 |
| other | Diarrhoea | Gastrointestinal disorders | Randomized Controlled Period: Pegcetacoplan | 2 | 63 | 3 |
| other | Diarrhoea | Gastrointestinal disorders | Randomized Controlled Period: Placebo | 7 | 61 | 8 |
1 to 10 of 224Source ClinicalTrials.gov
See all 224 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Randomized Controlled Period: Pegcetacoplan | 1 | 63 |
| Total, all-cause mortality | Randomized Controlled Period: Placebo | 0 | 61 |
| Total, all-cause mortality | Open-Label Period: Pegcetacoplan to Pegcetacoplan | 0 | 61 |
| Total, all-cause mortality | Open-Label Period: Placebo to Pegcetacoplan | 0 | 57 |
| Total, other adverse events | Randomized Controlled Period: Pegcetacoplan | 53 | 63 |
| Total, other adverse events | Randomized Controlled Period: Placebo | 56 | 61 |
| Total, other adverse events | Open-Label Period: Pegcetacoplan to Pegcetacoplan | 47 | 61 |
| Total, other adverse events | Open-Label Period: Placebo to Pegcetacoplan | 42 | 57 |
| Total, serious adverse events | Randomized Controlled Period: Pegcetacoplan | 6 | 63 |
| Total, serious adverse events | Randomized Controlled Period: Placebo | 6 | 61 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
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.
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