A Phase 3 Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Adults at High Risk of De… (NCT07020832) | Clinical Trial Compass
RecruitingPhase 3
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
Brazil320 participantsStarted 2026-02
Plain-language summary
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
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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 your transplant and produce very little urine (less than 200 mL per day equivalent to ≤1 cup). You must have been on dialysis for at least 3 months.
✓. Be receiving your first or second kidney transplant from a deceased donor. If this is your second transplant:
✓. It cannot be due to a serious infection or a serious blood clot in your previous transplant.
✓. Your calculated Panel Reactive Antibody (CPRA) level must be below 50%.
✓. Be getting a donor kidney that meets the study's specific requirements.
✓. Be at low to medium risk of transplant rejection, and be scheduled to receive:
Exclusion criteria
✕. Have taken part in another medical research study or used an experimental drug, treatment, or device in the past 30 days (or longer, depending on the drug).
✕. Have recently used certain medications that affect the immune system, such as rituximab, belimumab, or other approved complement-blocking drugs.
✕. Weigh less than 20kg or more than 120kg at screening.
✕. Have or had recently had any of the following infections: