RecruitingPhase 3NCT07020832

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

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 (DGF) Following Kidney Allograft Transplantation


Sponsor

Apellis Pharmaceuticals, Inc.

Enrollment

320 participants

Start Date

Feb 1, 2026

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This Phase 3 study is testing whether a drug called pegcetacoplan (which targets part of the immune system called complement) can prevent a complication called delayed graft function (DGF) — where a transplanted kidney is slow to start working — in high-risk kidney transplant recipients. **You may be eligible if...** - You have end-stage kidney disease, are on dialysis (for at least 3 months), and produce very little urine - You are waiting for your first or second kidney transplant from a deceased donor - Your antibody levels (CPRA) are below 50%, meaning rejection risk is lower - You are considered low-to-moderate rejection risk by your transplant team **You may NOT be eligible if...** - You are receiving a living donor kidney transplant - This is your third or more kidney transplant - Your prior transplant failed due to serious infection or blood clot - You have high levels of donor-specific antibodies Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPegcetacoplan

Complement (C3) Inhibitor

OTHERPlacebo

Sterile solution of equal volume to active arm


Locations(1)

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

São Paulo, Brazil

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NCT07020832


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