Clinical trial Recruiting at 113 sites Phase 3 Interventional Ages 18 and up

Evaluating Ravulizumab for Reducing Delayed Graft Function After Kidney Transplant

Official title: 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

Run by Alexion Pharmaceuticals, Inc. · NCT06830798 · Data updated 2026-11-12

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
Ages18 Years and up
SexAll
Enrollment450 (estimated)
SponsorAlexion Pharmaceuticals, Inc.
Industry-sponsored
Drugs / interventionsravulizumab
Locations130 sites (Phoenix, Arizona and 129 other locations)
StatusRecruiting
StartedMay 19, 2025
Main results expectedNovember 30, 2027
Study endsAugust 30, 2028
Registry record updatedJune 18, 2026
Trial IDNCT06830798 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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

Who can join: the full rules

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 it's running

  • Research Site
    Phoenix, Arizona, United States
    Recruiting
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    Los Angeles, California, United States
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    San Francisco, California, United States
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    Stanford, California, United States
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    New Haven, Connecticut, United States
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    Jacksonville, Florida, United States
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Show 44 more locations
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    Tampa, Florida, United States
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    Atlanta, Georgia, United States
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    Chicago, Illinois, United States
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    Chicago, Illinois, United States
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    Fairway, Kansas, United States
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    Lexington, Kentucky, United States
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    Kenner, Louisiana, United States
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    Ann Arbor, Michigan, United States
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    Detroit, Michigan, United States
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    Minneapolis, Minnesota, United States
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    St Louis, Missouri, United States
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    Omaha, Nebraska, United States
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    Livingston, New Jersey, United States
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    New York, New York, United States
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    Durham, North Carolina, United States
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    Philadelphia, Pennsylvania, United States
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    Greenville, South Carolina, United States
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    Nashville, Tennessee, United States
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    Dallas, Texas, United States
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    Houston, Texas, United States
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    Charlottesville, Virginia, United States
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    Richmond, Virginia, United States
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    Seattle, Washington, United States
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    Milwaukee, Wisconsin, United States
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    Buenos Aires, Argentina
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    Buenos Aires, Argentina
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    Buenos Aires, Argentina
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    Córdoba, Argentina
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    Adelaide, Australia
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    Brisbane, Australia
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    Camperdown, Australia
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    Murdoch, Australia
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    Innsbruck, Austria
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    Vienna, Austria
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    Belo Horizonte, Brazil
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    Belo Horizonte, Brazil
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    Botucatu, Brazil
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    Campinas, Brazil
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    Fortaleza, Brazil
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    Porto Alegre, Brazil
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    Porto Alegre, Brazil
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    Recife, Brazil
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    Rio de Janeiro, Brazil
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    São José do Rio Preto, Brazil
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+80 more sites. See ClinicalTrials.gov for the full list.

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 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.