A Phase 3 Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Adults at High Risk of Delayed Graft Function (DGF) Following Kidney Allograft Transplantation

Sponsor
Apellis Pharmaceuticals, Inc.
Study ID
NCT07020832
Phase
PHASE3
Status
Recruiting
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Conditions

  • Deceased Donor Kidney Transplant
  • Delayed Graft Function
  • End Stage Renal Disease

Eligibility Criteria

Sex
ALL
Age
18 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

A Phase 3 Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Adults at High Risk of Delayed Graft Function (DGF) Following Kidney Allograft Transplantation

Key Dates

Start date
Feb 28, 2026
Status verified
Jun 2025
Primary completion
Aug 31, 2027
Completion
Aug 31, 2028

Study Design

Enrollment
320 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Pegceptacoplan
    Administration as a 20mL IV infusion initially, then as a subcutaneous infusion
  • Placebo Comparator: Placebo
    Administration as a 20mL IV infusion initially, then as a subcutaneous infusion

Primary Outcome Measure

Time to freedom from dialysis through Day 90 [ Time Frame: Duration of dialysis through day 90 ]

Central Contacts

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