Actively Recruiting
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
Led by Apellis Pharmaceuticals, Inc. · Updated on 2026-03-13
320
Participants Needed
1
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official 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 kidney transplant from a deceased donor
- Be on dialysis at the time of transplant and produce less than 200 mL of urine per day, having been on dialysis for at least 3 months
- Receiving first or second kidney transplant from a deceased donor; if second, not due to serious infection or blood clot and CPRA level below 50%
- Receiving a donor kidney meeting the study's specific requirements
- At low to medium risk of transplant rejection and scheduled to receive ATG medication, steroids at screening, and tacrolimus or similar drug after transplant
- Have received pneumococcal, meningococcal (types A, C, W, Y, B), and Haemophilus influenzae type B vaccines or will receive preventive antibiotics until vaccination as per protocol
You will not qualify if you...
- Participated in another medical research study or used experimental treatments in the past 30 days or longer depending on the drug
- Recently used medications affecting the immune system such as rituximab, belimumab, or other approved complement-blocking drugs
- Weigh less than 20 kg or more than 120 kg at screening
- Have or recently had hepatitis B or C (unless treated and inactive) or HIV at any time
- Had cancer within the past 5 years except small treated skin cancer or very small treated kidney cancer
- Received any other organ transplant except one previous kidney transplant or scheduled for multi-organ transplant
AI-Screening
AI-Powered Screening
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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
CONTACT
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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