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 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: D928EC000012024-517568-48
• Study Type: interventional
• Target: 450
• Locations: 17 countries
• Sites: 128

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

Kidney Transplant; Delayed Graft Function; DGF

Keywords

Delayed Graft Function; DGF; Kidney Transplant; Ravulizumab

Outcome Measures

Primary Outcomes (1)

• Time to Freedom from Dialysis

  Through 90 days post-transplant

Secondary Outcomes (3)

• DGF Incidence

  Up to 7 days post-transplant

• Number of Dialysis Sessions

  Through 90 days post-transplant

• Time to Occurrence of eGFR reaching 30 mL/min/1.73 m2

  Through 90 days post-transplant

Study Arms (2)

Ravulizumab

EXPERIMENTAL

Participants will receive an IV dose of ravulizumab.

Drug: Ravulizumab

Placebo

PLACEBO COMPARATOR

Participants will receive an IV dose of placebo.

Drug: Placebo

Interventions

Ravulizumab DRUG

Participants will receive ravulizumab via intravenous (IV) infusion.

Ravulizumab

Placebo DRUG

Participants will receive placebo via intravenous (IV) infusion.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Alexion Pharmaceuticals, Inc.: lead

Study Sites (130)

Research Site

Phoenix, Arizona, 85054, United States

RECRUITING

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Los Angeles, California, 90095, United States

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San Francisco, California, 94115, United States

WITHDRAWN

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San Francisco, California, 94143, United States

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Stanford, California, 94305, United States

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New Haven, Connecticut, 06510, United States

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Jacksonville, Florida, 32224, United States

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Tampa, Florida, 33606, United States

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Atlanta, Georgia, 30322, United States

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Chicago, Illinois, 60608, United States

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Chicago, Illinois, 60637, United States

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Fairway, Kansas, 66205, United States

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Lexington, Kentucky, 40508, United States

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Kenner, Louisiana, 70065, United States

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Ann Arbor, Michigan, 48109, United States

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Detroit, Michigan, 48202, United States

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Minneapolis, Minnesota, 55455, United States

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St Louis, Missouri, 63108, United States

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Omaha, Nebraska, 68198, United States

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Livingston, New Jersey, 07039, United States

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New York, New York, 10016, United States

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New York, New York, 10065, United States

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Durham, North Carolina, 27705, United States

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Philadelphia, Pennsylvania, 19140, United States

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Greenville, South Carolina, 29605, United States

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Nashville, Tennessee, 37232, United States

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Dallas, Texas, 75235, United States

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Houston, Texas, 77030, United States

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Charlottesville, Virginia, 22908, United States

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Richmond, Virginia, 23298, United States

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Seattle, Washington, 98104, United States

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Milwaukee, Wisconsin, 53226, United States

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Buenos Aires, 1425, Argentina

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Buenos Aires, C1431FWO, Argentina

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Buenos Aires, Argentina

NOT YET RECRUITING

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Capital Federal, C1155ADP, Argentina

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Córdoba, X5016LIG, Argentina

NOT YET RECRUITING

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Adelaide, 5000, Australia

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Brisbane, 4102, Australia

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Camperdown, 2050, Australia

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Murdoch, 6150, Australia

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Innsbruck, 6020, Austria

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Vienna, 1090, Austria

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Belo Horizonte, 30130-100, Brazil

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Belo Horizonte, 30150-221, Brazil

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Botucatu, 18618-970, Brazil

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Botucatu, 18618-970, Brazil

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Campinas, 13083, Brazil

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Fortaleza, 60175295, Brazil

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Porto Alegre, 90035-903, Brazil

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Porto Alegre, 90050-170, Brazil

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Recife, 50070-550, Brazil

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Rio de Janeiro, 1033, Brazil

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São José do Rio Preto, 15090-000, Brazil

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São Paulo, 04036-002, Brazil

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Edmonton, Alberta, T6G 2E1, Canada

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Vancouver, British Columbia, V5Z 1M9, Canada

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Toronto, Ontario, M5B 1W8, Canada

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Toronto, Ontario, M5G 2C4, Canada

NOT YET RECRUITING

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Montreal, Quebec, H3T 1E2, Canada

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Guangzhou, 510080, China

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Guangzhou, 510260, China

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Guangzhou, 510280, China

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Hangzhou, 310015, China

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Hengyang, 441021, China

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Nanning, 530007, China

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Shenzhen, 518020, China

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Taiyuan, 030032, China

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Taiyuan, 030032, China

NOT YET RECRUITING

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Tianjin, 300192, China

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Zhengzhou, 450003, China

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Hradec Kralova, 50005, Czechia

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Ostrava, 708 52, Czechia

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Prague, 140 21, Czechia

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Créteil, 94000, France

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La Rochelle, 17019, France

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La Tronche, 38700, France

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Montpellier, 34295, France

NOT YET RECRUITING

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Nantes, 44093, France

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Paris, 75651, France

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Toulouse, 31059, France

NOT YET RECRUITING

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Berlin, 10117, Germany

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Erlangen, 91054, Germany

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Lübeck, 23538, Germany

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Mainz Am Rhein, 55131, Germany

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Münster, 48149, Germany

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Bologna, 40138, Italy

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Milan, 20122, Italy

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Milan, 20162, Italy

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Padova, 35128, Italy

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Parma, 43100, Italy

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Torino, 10126, Italy

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Kyoto, 602-8566, Japan

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Suita-shi, 565-0871, Japan

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Bydgoszcz, 85-094, Poland

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Gdansk, 80-214, Poland

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Poznan, 60-355, Poland

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Warsaw, 02-091, Poland

NOT YET RECRUITING

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Lisbon, 1069-166, Portugal

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Lisbon, 1499-005, Portugal

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Lisbon, 1649-035, Portugal

NOT YET RECRUITING

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Porto, 4050-313, Portugal

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Porto, 4200319, Portugal

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Gyeonggi-do, 13620, South Korea

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Seoul, 03080, South Korea

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Seoul, 03722, South Korea

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Badajoz, 06080, Spain

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Barakaldo, 48903, Spain

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Barcelona, 08025, Spain

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Barcelona, 08035, Spain

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Barcelona, 08036, Spain

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Barcelona, 08907, Spain

NOT YET RECRUITING

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Barcelona, 8003, Spain

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Cadiz, 11009, Spain

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Córdoba, 14004, Spain

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Granada, 18014, Spain

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Madrid, 28041, Spain

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Málaga, 29010, Spain

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Valencia, 46009, Spain

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Valencia, 46017, Spain

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Zaragoza, 50009, Spain

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Kaohsiung City, 833, Taiwan

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Taichung, 40447, Taiwan

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Taipei, 110, Taiwan

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Taoyuan District, 333, Taiwan

NOT YET RECRUITING

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Leeds, LS9 7TF, United Kingdom

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London, E1 1BB, United Kingdom

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London, NW3 2QG, United Kingdom

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London, SE1 9RT, United Kingdom

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Woodville South, 5011, United Kingdom

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MeSH Terms

Conditions

Delayed Graft Function

Interventions

ravulizumab

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Alexion Pharmaceuticals, Inc. (Sponsor)

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: February 17, 2025
• Study Start: May 19, 2025
• Primary Completion (Estimated): February 4, 2028
• Study Completion (Estimated): November 6, 2028
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

BR (12); GB (5); US (32); AR (5); PL (4); AU (4); ES (15); TW (4); IT (6); CN (11); KR (3); PT (5); FR (7); JP (2); DE (5); CZ (3); CA (5)