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NCT04572854 · ClinicalTrials.gov registry record · Phase 2
Study Assessing the Safety and Efficacy of Pegcetacoplan in Post-Transplant Recurrence of C3G or IC-MPGN
A Phase 2 study of Renal Transplant and C3 Glomerulopathy, sponsored by Apellis Pharmaceuticals.
- Active
- Registry status
- Phase 2
- Development phase
- 13
- Enrollment target
- 20
- Study locations
NCT04572854: Active Phase 2 study of Renal Transplant and C3 Glomerulopathy, sponsored by Apellis Pharmaceuticals.
NCT04572854 is a Phase 2 study of Renal Transplant and C3 Glomerulopathy that is active but no longer recruiting, run by Apellis Pharmaceuticals. The registered enrollment target is 13 participants, below the 50-participant average among 5 other Renal Transplant trials with a reported enrollment target (74% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04572854, a Phase 2 study of Renal Transplant and C3 Glomerulopathy, is active but no longer recruiting, sponsored by Apellis Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 13 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a Phase 2, multicenter, open-label, randomized, controlled study designed to evaluate the safety and efficacy of pegcetacoplan in patients who have post-transplant recurrence of C3G or IC-MPGN.
Primary Outcome
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
Conditions Studied
Interventions
- DRUG Pegcetacoplan
Study Locations (20)
Other
- Hospital Universitario Fundacion Favaloro - Buenos Aires
- Monash Medical Centre - Clayton
- Medical University of Vienna - Vienna
- Santa Casa de Misericordia de Belo Horizonte - Belo Horizonte
- Clinical Research Center, Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo - São Paulo
- Lille Regional University Hospital Center, Claude Huriez Hospital, Department of Nephrology - Lille
- Hopital Edouard Herriot, Hospices Civils de Lyon - Lyon
- Center Hospitalier Universitaire de Montpellier - Montpellier
- Istituto di Ricerche Farmacologiche Mario Negri IRCCS - Ranica
New York
- NYU Langone Health Transplant Insitute - New York
- CUIMC - New York
Arizona
- Mayo Clinic Arizona - Phoenix
California
- Keck School of Medicine, University of Southern California - Los Angeles
Colorado
- Children's Hospital Colorado - Aurora
Minnesota
- Mayo Clinic - Rochester
Missouri
- Washington University, St.Louis - St Louis
Buenos Aires
- Hospital de Alta Complejidad en Red El Cruce Dr. Nestor Carlos Kirchner - San Juan Bautista
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2021-09-07 |
| Est. Completion | 2026-01 |
| Phase | Phase 2 |
What the registry record for NCT04572854 still lists
NCT04572854 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 50-participant average among 5 other Renal Transplant trials with a reported enrollment target (74% lower).
The record links to 10 conditions, with Renal Transplant appearing as the primary indexed condition, and to 1 intervention - of which Pegcetacoplan is the first listed.
NCT04572854 names 20 study sites across 11 states, led by Other, New York, Arizona.
Frequently Asked Questions
What is clinical trial NCT04572854 about?
NCT04572854 is a clinical study titled "Study Assessing the Safety and Efficacy of Pegcetacoplan in Post-Transplant Recurrence of C3G or IC-MPGN". This is a Phase 2, multicenter, open-label, randomized, controlled study designed to evaluate the safety and efficacy of pegcetacoplan in patients who have post-transplant recurrence of C3G or IC-MPGN.
What is the current status of trial NCT04572854?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 13 participants. The study started on 2021-09-07. Estimated completion is 2026-01.
What conditions does trial NCT04572854 study?
This clinical trial studies the following conditions: Renal Transplant, C3 Glomerulopathy, C3G, IC-MPGN, Complement 3 Glomerulopathy.
What interventions are being tested in trial NCT04572854?
The interventions under investigation include: Pegcetacoplan (DRUG).
Who is sponsoring clinical trial NCT04572854?
This trial is sponsored by Apellis Pharmaceuticals, which has 21 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04572854 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Minnesota, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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