Recruiting

Phase 3

RavulizumabDouble-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

Sponsor:

Alexion Pharmaceuticals, Inc.

Code:

NCT06830798

Conditions

Delayed Graft Function

DGF

Kidney Transplant

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ravulizumab

Placebo

Study Details

Brief 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.

Conditions

Delayed Graft Function

DGF

Kidney Transplant

Study ID

NCT06830798

Start date

May 19, 2025

Status verified date

Jun, 2026

Completion date

Aug 30, 2028

Anticipated

Primary completion date

Nov 30, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

450 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Ravulizumab

Participants will receive an IV dose of ravulizumab.

placebo comparator: Placebo

Participants will receive an IV dose of placebo.

Interventions

Ravulizumab

Participants will receive ravulizumab via intravenous (IV) infusion.

Placebo

Participants will receive placebo via intravenous (IV) infusion.

Primary outcome measure

Time to Freedom from Dialysis [ Time Frame: Through 90 days post-transplant ]

Central Contacts and Locations

Central contacts

Alexion Pharmaceuticals, Inc. (Sponsor)

1-855-752-2356 clinicaltrials@alexion.com

Locations

Research Site

Recruiting

Phoenix, Arizona, United States, 85054

Research Site

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Los Angeles, California, United States, 90095

Research Site

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San Francisco, California, United States, 94143

Research Site

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Stanford, California, United States, 94305

Research Site

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New Haven, Connecticut, United States, 06510

Research Site

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Jacksonville, Florida, United States, 32224

Research Site

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Tampa, Florida, United States, 33606

Research Site

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Atlanta, Georgia, United States, 30322

Research Site

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Chicago, Illinois, United States, 60608

Research Site

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Chicago, Illinois, United States, 60637

Research Site

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Fairway, Kansas, United States, 66205

Research Site

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Lexington, Kentucky, United States, 40508

Research Site

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Kenner, Louisiana, United States, 70065

Research Site

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Ann Arbor, Michigan, United States, 48109

Research Site

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Detroit, Michigan, United States, 48202

Research Site

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Minneapolis, Minnesota, United States, 55455

Research Site

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St Louis, Missouri, United States, 63108

Research Site

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Omaha, Nebraska, United States, 68198

Research Site

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Livingston, New Jersey, United States, 07039

Research Site

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New York, New York, United States, 10065

Research Site

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Durham, North Carolina, United States, 27705

Research Site

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Philadelphia, Pennsylvania, United States, 19140

Research Site

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Greenville, South Carolina, United States, 29605

Research Site

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Nashville, Tennessee, United States, 37232

Research Site

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Dallas, Texas, United States, 75235

Research Site

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Houston, Texas, United States, 77030

Research Site

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Charlottesville, Virginia, United States, 22908

Research Site

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Richmond, Virginia, United States, 23298

Research Site

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Seattle, Washington, United States, 98104

Research Site

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Milwaukee, Wisconsin, United States, 53226

Research Site

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Edmonton, Alberta, Canada, T6G 2E1

Research Site

Recruiting

Vancouver, British Columbia, Canada, V5Z 1M9

Research Site

Recruiting

Toronto, Ontario, Canada, M5B 1W8

More Information

Sponsor

Alexion Pharmaceuticals, Inc.

Last update posted

Jun 18, 2026

Last verified

Jun, 2026

Keywords

Delayed Graft Function
DGF
Kidney Transplant
Ravulizumab

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Alexion Pharmaceuticals, Inc. on 2026-06-18.