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 now · Phase 3 · Has a placebo group
Conditions studied: Delayed Graft Function, DGF, Kidney Transplant
In brief
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.
Key facts
- Study ID
- NCT06830798
- Run by
- Alexion Pharmaceuticals, Inc.
- People needed
- 450
- Starts
- 2025-05-19
- Expected to finish
- 2028-08-30
- Last updated by the study team
- 2026-06-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- ≥ 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:
- Donation after Circulatory Death (DCD) donor
- High-risk Donation after Brain Death (DBD) donor
You may not qualify if…
- 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.
Where it is running
- Research Site — Nashville, Tennessee, United States (enrolling)
- Research Site — Phoenix, Arizona, United States (enrolling)
- Research Site — San Francisco, California, United States (enrolling)
- Research Site — Los Angeles, California, United States (enrolling)
- Research Site — New Haven, Connecticut, United States (enrolling)
- Research Site — Jacksonville, Florida, United States (enrolling)
- Research Site — Tampa, Florida, United States (enrolling)
- Research Site — Atlanta, Georgia, United States (enrolling)
- Research Site — Stanford, California, United States (enrolling)
- Research Site — Chicago, Illinois, United States (enrolling)
- Research Site — Fairway, Kansas, United States (enrolling)
- Research Site — Lexington, Kentucky, United States (enrolling)
- Research Site — Kenner, Louisiana, United States (enrolling)
- Research Site — Ann Arbor, Michigan, United States (enrolling)
- Research Site — Detroit, Michigan, United States (enrolling)
- Research Site — Minneapolis, Minnesota, United States (enrolling)
- Research Site — St Louis, Missouri, United States (enrolling)
- Research Site — Omaha, Nebraska, United States (enrolling)
- Research Site — Livingston, New Jersey, United States (enrolling)
- Research Site — Chicago, Illinois, United States (enrolling)
- Research Site — New York, New York, United States (enrolling)
- Research Site — Durham, North Carolina, United States (enrolling)
- Research Site — Philadelphia, Pennsylvania, United States (enrolling)
- Research Site — Greenville, South Carolina, United States (enrolling)
- Research Site — Dallas, Texas, United States (enrolling)
Full record on ClinicalTrials.gov
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