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

Launched by ALEXION PHARMACEUTICALS, INC. · Feb 12, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a medication called ravulizumab to see if it can help people who are at high risk of experiencing Delayed Graft Function (DGF) after receiving a kidney transplant. DGF is a condition where the transplanted kidney doesn’t start working right away, and patients may need to rely on dialysis, a treatment that helps filter waste from the blood. The goal of the study is to find out if ravulizumab can help patients spend less time on dialysis after their transplant compared to a placebo (a dummy treatment that does not contain the active drug).

To be eligible for the trial, participants must be at least 18 years old and have severe kidney disease that requires dialysis. They should also be candidates for a kidney transplant from specific types of donors, such as those who have died from a lack of blood flow or certain high-risk brain death donors. It’s important to note that individuals receiving kidneys from specific donor categories or who have severe acute kidney injury won’t be eligible. Participants in the trial can expect to be closely monitored throughout the study, and their responses to the treatment will be compared with those who receive the placebo to determine the effectiveness and safety of the medication. This study is not yet recruiting participants, so there will be more information available in the future.

Gender

ALL

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.