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NCT05809531 · ClinicalTrials.gov registry record · Phase 3
An Open-Label, Nonrandomized, Multicenter Extension Study to Evaluate the Long-term Safety and Efficacy of Pegcetacoplan in Participants With C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis
A Phase 3 study of C3 Glomerulopathy and C3G, sponsored by Apellis Pharmaceuticals.
- Active
- Registry status
- Phase 3
- Development phase
- 100
- Enrollment target
- 20
- Study locations
NCT05809531 is a Phase 3 study of C3 Glomerulopathy and C3G that is active but no longer recruiting, run by Apellis Pharmaceuticals. The registered enrollment target is 100 participants, below the 113-participant average among 3 other C3 Glomerulopathy trials with a reported enrollment target (12% lower). The trial reports 20 study locations across 15 states.
The verdict
NCT05809531, a Phase 3 study of C3 Glomerulopathy and C3G, is active but no longer recruiting, sponsored by Apellis Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 100 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study is designed as a long-term extension to Study APL2-C3G-310, and is being conducted to establish the long-term safety and efficacy of pegcetacoplan in patients with C3 glomerulopathy (C3G) or immune-complex membranoproliferative glomerulonephritis (IC-MPGN).
Conditions Studied
Interventions
- DRUG Pegcetacoplan
Study Locations (20)
Other
- Hospital Privado-Universitario de Cordoba (54004) - Córdoba
- Clinica Privada Velez Sarsfield (54007) - Córdoba
- St. Vincent's Hospital Melbourne (61003) - Fitzroy
- Catholic University of Leuven (32001) - Leuven
- HC UNESP Botucatu (55010) - Botucatu
New York
- Cohen Children Hospital, Pediatric Pharmacy (01022) - Hyde Park
- Columbia Nephrology (01039) - New York
California
- Academic Medical Research Institute (01034) - Los Angeles
Colorado
- Children's Hospital Colorado (01037) - Aurora
Florida
- University of Florida, Department of Pediatric Nephrology (01010) - Gainesville
Georgia
- Emory Investigational Drug Service (01021) - Atlanta
Iowa
- University of Iowa Hospital and Clinics (01030) - Iowa City
Michigan
- University of Michigan Hospital (01008) - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2023-05-29 |
| Est. Completion | 2027-07 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05809531
The ClinicalTrials.gov registry entry for NCT05809531 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 113-participant average among 3 other C3 Glomerulopathy trials with a reported enrollment target (12% lower). The listed sponsor is Apellis Pharmaceuticals, which has 21 total studies on file at ClinicalTrials.gov.
The record links to 10 conditions, with C3 Glomerulopathy appearing as the primary indexed condition, and to 1 intervention - of which Pegcetacoplan is the first listed.
NCT05809531 reports 20 study locations spanning 15 distinct geographic areas - top geographies include Other, New York, California.
Frequently Asked Questions
What is clinical trial NCT05809531 about?
NCT05809531 is a clinical study titled "An Open-Label, Nonrandomized, Multicenter Extension Study to Evaluate the Long-term Safety and Efficacy of Pegcetacoplan in Participants With C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis". This study is designed as a long-term extension to Study APL2-C3G-310, and is being conducted to establish the long-term safety and efficacy of pegcetacoplan in patients with C3 glomerulopathy (C3G) or immune-complex membranoproliferative glomerulonephritis (IC-MPGN).
What is the current status of trial NCT05809531?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 100 participants. The study started on 2023-05-29. Estimated completion is 2027-07.
What conditions does trial NCT05809531 study?
This clinical trial studies the following conditions: C3 Glomerulopathy, C3G, IC-MPGN, C3 Glomerulonephritis, Complement 3 Glomerulopathy.
What interventions are being tested in trial NCT05809531?
The interventions under investigation include: Pegcetacoplan (DRUG).
Who is sponsoring clinical trial NCT05809531?
This trial is sponsored by Apellis Pharmaceuticals, which has 21 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05809531 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Georgia, Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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