Study Assessing the Safety and Efficacy of Pegcetacoplan in Post-Transplant Recurrence of C3G or IC-MPGN

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Apellis Pharmaceuticals, Inc.
Study ID
NCT04572854
Phase
PHASE2
Status
Completed

Conditions

  • C3 Glomerulonephritis
  • C3 Glomerulopathy
  • C3G
  • Complement 3 Glomerulonephritis
  • Complement 3 Glomerulopathy
  • Complement 3 Glomerulopathy (C3G)
  • Dense Deposit Disease (DDD)
  • IC-MPGN
  • Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN)
  • Membranoproliferative Glomerulonephritis
  • Membranoproliferative Glomerulonephritis (MPGN)
  • Renal Transplant

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Sep 7, 2021
Status verified
Mar 2026
Primary completion
Feb 27, 2023
Completion
Jan 20, 2026

Study Design

Enrollment
13 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group 1
    Pegcetacoplan treatment of 1080 mg (sub-cutaneous infusion) twice weekly will be given throughout the entire study.
  • Other: Group 2
    No intervention given during the randomized controlled portion of the study (through week 12). After week 12, subjects will receive pegcetacoplan treatment.

Primary Outcome Measure

Percentage of Subjects With Reduction in C3c Staining on Renal Biopsy at Week 12 [ Time Frame: Baseline (Day 1) and Week 12 ]

Locations (7)

FacilityCityStateZIPSite coordinators
Mayo Clinic ArizonaPhoenixArizona85054-
Keck School of Medicine, University of Southern CaliforniaLos AngelesCalifornia900033-
Children's Hospital ColoradoAuroraColorado80045-
Mayo ClinicRochesterMinnesota55905-
Washington University, St.LouisSt LouisMissouri63110-
CUIMCNew YorkNew York10032-
NYU Langone Health Transplant InsituteNew YorkNew York10016-

Related coverage on Hipa.ai

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Mayo Clinic Arizona· Phoenix, AZKeck School of Medicine, University of Southern California· Los Angeles, CAChildren's Hospital Colorado· Aurora, COMayo Clinic· Rochester, MNWashington University, St.Louis· St Louis, MOCUIMC· New York, NY

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