NCT06830798 Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab Administered Intravenously in Adult Participants at High Risk of Delayed Graft Function After Kidney Transplantation
| NCT ID | NCT06830798 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Alexion Pharmaceuticals, Inc. |
| Condition | Delayed Graft Function |
| Study Type | INTERVENTIONAL |
| Enrollment | 450 participants |
| Start Date | 2025-05-19 |
| Primary Completion | 2028-02-04 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
The primary objective of this study is to demonstrate the efficacy of ravulizumab vs placebo in reducing the severity of DGF as measured by time to freedom from dialysis in adult participants who are at high risk of DGF after undergoing transplant of deceased donor kidney.
Eligibility Criteria
Inclusion Criteria: * ≥ 18 years of age at the time of signing the informed consent * Diagnosed with Dialysis-dependent End-Stage Kidney Disease (ESKD) * A candidate for kidney transplant from: 1. Donation after Circulatory Death (DCD) donor 2. High-risk Donation after Brain Death (DBD) donor Exclusion Criteria: * Is to receive a kidney from a donor with category I,II,IV and V Maastricht Classification * Diagnosed with Acute Kidney Injury (AKI) of Stage 3 severity according to the Kidney Disease: Improving Global Outcomes (KDIGO) guidelines.