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Recruiting 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

Conditions: Delayed Graft Function, DGF, Kidney Transplant

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 450
Sponsor: Alexion Pharmaceuticals, Inc.

Location: Research Site Phoenix Arizona

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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06830798). StuddyBuddy aggregates publicly available trial information.