Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safe… (NCT06830798) | Clinical Trial Compass
RecruitingPhase 3
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
United States, Argentina, Australia450 participantsStarted 2025-05-19
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Donation after Circulatory Death (DCD) donor
. High-risk Donation after Brain Death (DBD) donor
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This is a Phase 3 trial testing ravulizumab against a placebo after kidney transplant — what does it mean for my safety that this is still Phase 3, and is there enough evidence so far that the benefits outweigh the risks of receiving an experimental drug right after a transplant?
2The trial is specifically for people at high risk of delayed graft function — based on my situation, do I actually fall into that high-risk category, and how would you define that for me?
3The main thing being measured is how long it takes to get off dialysis after the transplant — given my health, what's a realistic expectation for that timeline with standard care versus what this trial is testing?
4Since this is a placebo-controlled study, there's a chance I could receive a placebo instead of ravulizumab right after my transplant — how would that affect my care if I do experience delayed graft function?
5Are there standard treatments or other approaches already proven to reduce the risk of delayed graft function that I should consider before deciding whether joining this trial makes sense for me?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.