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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Apellis Pharmaceuticals, Inc.
Study ID
NCT05809531
Phase
PHASE3
Status
Active Not Recruiting

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

Study Details

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).

Key Dates

Start date
May 29, 2023
Status verified
Mar 2026
Primary completion
Jul 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Pegcetacoplan administered subcutaneously
    Pegcetacoplan administered subcutaneously twice weekly according to protocol defined dosing regimen

Primary Outcome Measure

Proportion of participants with a reduction in urine protein-to-creatinine ratio (uPCR) of at least 50% from the pretreatment value over time. [ Time Frame: 2.5 years ]

Locations (12)

FacilityCityStateZIPSite coordinators
Academic Medical Research Institute (01034)Los AngelesCalifornia90022-
Children's Hospital Colorado (01037)AuroraColorado80045-
University of Florida, Department of Pediatric Nephrology (01010)GainsvilleFlorida32610-
Emory Investigational Drug Service (01021)AtlantaGeorgia30322-
University of Iowa Hospital and Clinics (01030)Iowa CityIowa52242-
University of Michigan Hospital (01008)Ann ArborMichigan48109-
Hackensack Meridian Health (01036)HackensackNew Jersey07601-
Cohen Children Hospital, Pediatric Pharmacy (01022)Hyde ParkNew York11040-
Columbia Nephrology (01039)New YorkNew York10032-
Oregon Health & Science Univ., Dept. Pediatrics (01038)PortlandOregon97239-
Northeast Clinical Research Center LLC (01009)BethlehemPennsylvania18017-
Texas Children's Hospital (01027)HoustonTexas77030-

Find similar trials in Los Angeles, CA

By research site
Academic Medical Research Institute (01034)· Los Angeles, CAChildren's Hospital Colorado (01037)· Aurora, COUniversity of Florida, Department of Pediatric Nephrology (01010)· Gainsville, FLEmory Investigational Drug Service (01021)· Atlanta, GAUniversity of Iowa Hospital and Clinics (01030)· Iowa City, IAUniversity of Michigan Hospital (01008)· Ann Arbor, MI

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