Phase III Study Assessing the Efficacy and Safety of Pegcetacoplan in Patients With C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Apellis Pharmaceuticals, Inc.
Study ID
NCT05067127
Phase
PHASE3
Status
Completed

Conditions

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

Eligibility Criteria

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

Interventions

  • Pegcetacoplan — DRUG
    Complement (C3) Inhibitor
  • Placebo — OTHER
    Sterile solution of equal volume to active arm

Study Details

This is a Phase 3 study to assess the efficacy and safety of twice-weekly subcutaneous (SC) doses of pegcetacoplan compared to placebo in patients with C3 glomerulopathy (C3G) or immune-complex membranoproliferative glomerulonephritis (IC-MPGN) on the basis of a reduction in proteinuria.

Key Dates

Start date
Nov 12, 2021
Status verified
Aug 2025
Primary completion
Jun 26, 2024
Completion
Jan 14, 2025

Study Design

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

Arms

  • Experimental: Group 1: Pegcetacoplan administration
    Subcutaneous infusion of 20mL (1080 mg), twice weekly (for adults or adolescents \>50kg), and the three other weight-based doses either of 10mL (540mg), 12mL (648mg), or 15mL (810mg)
  • Placebo Comparator: Group 2: Placebo administration
    Subcutaneous infusion of either 10mL, 12mL, 15mL, or 20mL, twice weekly

Primary Outcome Measure

Randomized Controlled Period: Change From Baseline in Log-Transformed Urine Protein-to-Creatinine Ratio (uPCR) at Week 26 [ Time Frame: Baseline (Day -70 to Day 1) to Week 26 ]

Locations (26)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294-
Academic Medical Research InstituteLos AngelesCalifornia90022-
Keck School of Medicine, University of Southern CaliforniaLos AngelesCalifornia90033-
Ronald Reagan UCLA Medical Center (01035)Los AngelesCalifornia90095-
UCI Center for Clinical ResearchOrangeCalifornia92868-
UC Davis Medical Center (Transplant Research) (01016)SacramentoCalifornia95817-
Children's Hospital ColoradoAuroraColorado80045-
University of FloridaGainesvilleFlorida32610-
Emory University School of MedicineAtlantaGeorgia30322-
Fides Clinical Research, LLC (01042)AtlantaGeorgia30342-
Institute for Public Health and Medicine Northwestern University Northwestern University (01041)ChicagoIllinois60611-
NANIU Research Chicago (01040)Oak BrookIllinois60523-
Nephrology Associates of Northern IL and Inn (01043)Fort WayneIndiana46804-
The University of IowaIowa CityIowa52242-
Boston Children's Hospital (01013)BostonMassachusetts02115-
Renal and Transplant Associates of New England, PCSpringfieldMassachusetts01107-
University of Michigan Medical CenterAnn ArborMichigan48109-
Children's Mercy HospitalKansas CityMissouri64102-
Hackensack Meridian HealthHackensackNew Jersey07601-
Cohen Children HospitalNew Hyde ParkNew York11040-
CUIMC - Columbia NephrologyNew YorkNew York10032-
The Ohio State University Medical CenterColumbusOhio43210-
Oregon Health & Science University (01038)PortlandOregon97239-
Northeast Clinical Research Center, LLCBethlehemPennsylvania18017-
MedResearch IncEl PasoTexas79902-
Texas Children's HospitalHoustonTexas77030-

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By research site
University of Alabama at Birmingham· Birmingham, ALAcademic Medical Research Institute· Los Angeles, CAKeck School of Medicine, University of Southern California· Los Angeles, CARonald Reagan UCLA Medical Center (01035)· Los Angeles, CAUCI Center for Clinical Research· Orange, CAUC Davis Medical Center (Transplant Research) (01016)· Sacramento, CA

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