Actively Recruiting
A Phase 3, Randomized, Placebo-Controlled, Double-Blinded, Multicenter Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Adults at High Risk of Delayed Graft Function Following Kidney Allograft Transplantation
Led by Apellis Pharmaceuticals, Inc. · Updated on 2026-03-13
320
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating pegcetacoplan, a complement (C3) inhibitor drug, in adults at high risk of delayed graft function (DGF) after receiving a kidney transplant from a deceased donor. This Phase 3, randomized, placebo-controlled, and double-blinded study aims to assess the effectiveness and safety of pegcetacoplan in helping kidney transplant patients who have end-stage renal disease and require dialysis. The study is sponsored by Apellis Pharmaceuticals, Inc. Participants will receive either pegcetacoplan or a placebo. Both treatments start with a 20 mL intravenous infusion and then continue with subcutaneous infusions. The study includes multiple assessment time points, such as through Day 90 and up to Week 52 following surgery, to monitor kidney function and graft survival. The treatment period involves careful medical management including use of medications like ATG, corticosteroids, and tacrolimus. During the study, participants will be closely monitored for dialysis needs, urine output, kidney function (eGFR), and rejection-free survival through various tests and clinical evaluations. Researchers will track the time to freedom from dialysis and changes in kidney function over time. Participants will be followed for safety and outcomes until at least 52 weeks after their transplant. The total duration includes screening, treatment, and follow-up phases to gather comprehensive data on the drug's impact.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged at least 18 years
- Have end-stage kidney disease and be on the waiting list for a deceased donor kidney transplant
- Be on dialysis at the time of transplant and produce less than 200 mL of urine per day
- Have been on dialysis for at least 3 months
- Receiving first or second kidney transplant from a deceased donor
- If second transplant, not due to serious infection or blood clot in previous transplant
- Panel Reactive Antibody (CPRA) level below 50% if second transplant
- Donor kidney meets specific study requirements
- At low to medium risk of transplant rejection
- Scheduled to receive ATG medication as part of transplant
- Scheduled to receive corticosteroids at screening
- Scheduled to receive tacrolimus or similar drug after transplant
- Have received pneumococcal, meningococcal, and Haemophilus influenzae type B vaccines or will receive antibiotics until vaccinated
You will not qualify if you...
- Participated in another medical study or used experimental drug/device within past 30 days or longer
- Recently used immune system medications such as rituximab, belimumab, or complement-blocking drugs
- Weigh less than 20 kg or more than 120 kg at screening
- Have or recently had active hepatitis B or C infection
- Have ever had HIV infection
- Had cancer in past 5 years except small treated skin cancer or very small treated kidney cancer
- Received any organ transplant other than one previous kidney transplant
- Scheduled for transplant involving more than one organ
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 90 days following kidney transplant surgery
Participants receive Pegcetacoplan or placebo starting with an initial 20mL IV infusion followed by subcutaneous infusions as part of the kidney transplant procedure and post-transplant care.
Multiple visits during the first 90 days post-transplant
Duration - Up to 52 weeks following kidney transplant surgery
Participants are monitored for kidney allograft function and safety outcomes after the treatment period.
Periodic visits up to 52 weeks post-transplant
Trial Site Locations
Total: 1 location
1
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, Brazil, 01323-001
Actively Recruiting
Research Team
A
Apellis Clinical Trial Information Line
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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