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Evaluating Ravulizumab for Reducing Delayed Graft Function After Kidney Transplant

A Phase 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

Phase 3 Interventional Alexion Pharmaceuticals, Inc. · NCT06830798

This study is testing if a new drug called ravulizumab can help kidney transplant patients avoid delayed graft function and reduce the need for dialysis.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment450 (estimated)
Ages18 Years and up
SexAll
SponsorAlexion Pharmaceuticals, Inc. Industry-sponsored
Drugs / interventionsravulizumab
Locations130 sites (Phoenix, Arizona and 129 other locations)
Trial IDNCT06830798 on ClinicalTrials.gov

What this trial studies

This study aims to assess the efficacy and safety of ravulizumab in adult kidney transplant recipients who are at high risk for delayed graft function (DGF). Participants will be randomly assigned to receive either ravulizumab or a placebo intravenously. The primary goal is to measure the time to freedom from dialysis, indicating the severity of DGF. This multicenter approach allows for a diverse patient population and robust data collection.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with dialysis-dependent end-stage kidney disease who are undergoing kidney transplantation from high-risk donors.

Not a fit: Patients receiving kidneys from donors classified as category I, II, IV, and V or those with acute kidney injury of stage 3 severity may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the incidence of delayed graft function in kidney transplant patients, improving their recovery and overall outcomes.

How similar studies have performed: Previous studies have shown promise in using monoclonal antibodies for similar conditions, suggesting potential success for this approach.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Phoenix, Arizona and 129 other locations

+80 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Delayed Graft FunctionDGFKidney TransplantRavulizumab
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.