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
Recruiting
Phase 3
Interventional Study
Delayed Graft Function
DGF
Kidney Transplant
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 450 (estimated)
- Sponsor
- Alexion Pharmaceuticals, Inc. · Industry
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About This Trial
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.
Trial Locations
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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
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Contacts