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

NCT06830798 · tracked via the Priya Life Science UK tracker

Sponsor

Alexion Pharmaceuticals, Inc.

Phase

Phase 3

Started

2025-05-19

Last updated

2026-06-18

Condition(s) studied

Delayed Graft FunctionDGFKidney Transplant

Investigational drug(s) / intervention(s)

RavulizumabPlacebo

Ravulizumab: Participants will receive ravulizumab via intravenous (IV) infusion.

Placebo: Participants will receive placebo via intravenous (IV) infusion.

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Time to Freedom from Dialysis — Through 90 days post-transplant

Trial sites (130)

Facility	City	Region	Status
Research Site	Phoenix	Arizona	Recruiting
Research Site	Los Angeles	California	Recruiting
Research Site	San Francisco	California	Withdrawn
Research Site	San Francisco	California	Recruiting
Research Site	Stanford	California	Recruiting
Research Site	New Haven	Connecticut	Recruiting
Research Site	Jacksonville	Florida	Recruiting
Research Site	Tampa	Florida	Recruiting
Research Site	Atlanta	Georgia	Recruiting
Research Site	Chicago	Illinois	Recruiting
Research Site	Chicago	Illinois	Recruiting
Research Site	Fairway	Kansas	Recruiting
Research Site	Lexington	Kentucky	Recruiting
Research Site	Kenner	Louisiana	Recruiting
Research Site	Ann Arbor	Michigan	Recruiting
Research Site	Detroit	Michigan	Recruiting
Research Site	Minneapolis	Minnesota	Recruiting
Research Site	St Louis	Missouri	Recruiting
Research Site	Omaha	Nebraska	Recruiting
Research Site	Livingston	New Jersey	Recruiting
Research Site	New York	New York	Withdrawn
Research Site	New York	New York	Recruiting
Research Site	Durham	North Carolina	Recruiting
Research Site	Philadelphia	Pennsylvania	Recruiting
Research Site	Greenville	South Carolina	Recruiting
Research Site	Nashville	Tennessee	Recruiting
Research Site	Dallas	Texas	Recruiting
Research Site	Houston	Texas	Recruiting
Research Site	Charlottesville	Virginia	Recruiting
Research Site	Richmond	Virginia	Recruiting
Research Site	Seattle	Washington	Recruiting
Research Site	Milwaukee	Wisconsin	Recruiting
Research Site	Buenos Aires	Argentina	Recruiting
Research Site	Buenos Aires	Argentina	Recruiting
Research Site	Buenos Aires	Argentina	Recruiting
Research Site	Capital Federal	Argentina	Not Yet Recruiting
Research Site	Córdoba	Argentina	Recruiting
Research Site	Adelaide	Australia	Recruiting
Research Site	Brisbane	Australia	Recruiting
Research Site	Camperdown	Australia	Recruiting

+ 90 more sites — see the full list on the official registry below.

On this site

📄 Ultomiris (ravulizumab) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06830798 on ClinicalTrials.gov ↗ ← All trials in the UK