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

Last updated: April 15, 2026
Sponsor: Alexion Pharmaceuticals, Inc.
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

Placebo

Ravulizumab

Clinical Study ID

NCT06830798
D928EC00001
2024-517568-48
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

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

Exclusion Criteria:

  • Is to receive a kidney from a donor with category I,II,IV and V MaastrichtClassification

  • Diagnosed with Acute Kidney Injury (AKI) of Stage 3 severity according to the KidneyDisease: Improving Global Outcomes (KDIGO) guidelines.

Study Design

Total Participants: 450
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
May 19, 2025
Estimated Completion Date:
November 06, 2028

Study Description

AWAKE is a multicenter, prospective study to evaluate the safety and efficacy of ravulizumab in reducing delayed graft function (DGF) in kidney transplant recipients at high risk for DGF. Eligible participants will be randomized in a 1:1 ratio to receive either ravulizumab or placebo intravenously.

Connect with a study center

  • Research Site

    Buenos Aires,
    Argentina

    Site Not Available

  • Research Site

    Buenos Aires 3435910, 1425
    Argentina

    Site Not Available

  • Research Site

    Capital Federal, C1155ADP
    Argentina

    Site Not Available

  • Research Site

    Córdoba, X5016LIG
    Argentina

    Site Not Available

  • Research Site

    Córdoba 3860259, X5016LIG
    Argentina

    Site Not Available

  • Research Site

    Adelaide, 5000
    Australia

    Active - Recruiting

  • Research Site

    Adelaide 2078025, 5000
    Australia

    Site Not Available

  • Research Site

    Brisbane, 4102
    Australia

    Active - Recruiting

  • Research Site

    Brisbane 2174003, 4102
    Australia

    Site Not Available

  • Research Site

    Camperdown, 2050
    Australia

    Active - Recruiting

  • Research Site

    Camperdown 2172563, 2050
    Australia

    Site Not Available

  • Research Site

    Murdoch, 6150
    Australia

    Active - Recruiting

  • Research Site

    Murdoch 8349091, 6150
    Australia

    Site Not Available

  • Research Site

    Innsbruck, 6020
    Austria

    Active - Recruiting

  • Research Site

    Innsbruck 2775220, 6020
    Austria

    Site Not Available

  • Research Site

    Vienna, 1090
    Austria

    Active - Recruiting

  • Research Site

    Vienna 2761369, 1090
    Austria

    Site Not Available

  • Research Site

    Belo Horizonte, 30150-221
    Brazil

    Active - Recruiting

  • Research Site

    Belo Horizonte 3470127, 30130-100
    Brazil

    Site Not Available

  • Research Site

    Botucatu, 18618-970
    Brazil

    Active - Recruiting

  • Research Site

    Botucatu 3469136, 18618-970
    Brazil

    Site Not Available

  • Research Site

    Bragança Paulista, 12916-542
    Brazil

    Site Not Available

  • Research Site

    Bragança Paulista 3469092, 12916-542
    Brazil

    Site Not Available

  • Research Site

    Campinas, 13083
    Brazil

    Active - Recruiting

  • Research Site

    Campinas 3467865, 13083
    Brazil

    Site Not Available

  • Research Site

    Fortaleza, 60175295
    Brazil

    Active - Recruiting

  • Research Site

    Fortaleza 3399415, 60175295
    Brazil

    Site Not Available

  • Research Site

    Porto Alegre, 90035-903
    Brazil

    Active - Recruiting

  • Research Site

    Porto Alegre 3452925, 90050-170
    Brazil

    Site Not Available

  • Research Site

    Recife, 50070-550
    Brazil

    Active - Recruiting

  • Research Site

    Recife 3390760, 50070-550
    Brazil

    Site Not Available

  • Research Site

    Rio de Janeiro, 1033
    Brazil

    Active - Recruiting

  • Research Site

    Rio de Janeiro 3451190, 1033
    Brazil

    Site Not Available

  • Research Site

    Sao Paulo, 01221-020
    Brazil

    Site Not Available

  • Research Site

    São José do Rio Preto, 15090-000
    Brazil

    Active - Recruiting

  • Research Site

    São José do Rio Preto 3448639, 15090-000
    Brazil

    Site Not Available

  • Research Site

    São Paulo, 04036-002
    Brazil

    Active - Recruiting

  • Research Site

    São Paulo 3448439, 01221-020
    Brazil

    Site Not Available

  • Research Site

    Edmonton, Alberta T6G 2E1
    Canada

    Active - Recruiting

  • Research Site

    Edmonton 5946768, Alberta 5883102 T6G 2E1
    Canada

    Site Not Available

  • Research Site

    Vancouver, British Columbia V5Z 1M9
    Canada

    Active - Recruiting

  • Research Site

    Vancouver 6173331, British Columbia 5909050 V5Z 1M9
    Canada

    Site Not Available

  • Research Site

    Toronto, Ontario M5G 2C4
    Canada

    Site Not Available

  • Research Site

    Toronto 6167865, Ontario 6093943 M5G 2C4
    Canada

    Site Not Available

  • Research Site

    Montreal, Quebec H3T 1E2
    Canada

    Site Not Available

  • Research Site

    Montreal 6077243, Quebec 6115047 H3T 1E2
    Canada

    Site Not Available

  • Research Site

    Guangzhou, 510080
    China

    Active - Recruiting

  • Research Site

    Guangzhou 1809858, 510280
    China

    Site Not Available

  • Research Site

    Hangzhou, 310015
    China

    Active - Recruiting

  • Research Site

    Hangzhou 1808926, 310015
    China

    Site Not Available

  • Research Site

    Hengyang, 441021
    China

    Active - Recruiting

  • Research Site

    Hengyang 1808370, 441021
    China

    Site Not Available

  • Research Site

    Nanning, 530007
    China

    Active - Recruiting

  • Research Site

    Nanning 1799869, 530007
    China

    Site Not Available

  • Research Site

    Shenzhen, 518020
    China

    Active - Recruiting

  • Research Site

    Shenzhen 1795565, 518020
    China

    Site Not Available

  • Research Site

    Taiyuan, 030032
    China

    Site Not Available

  • Research Site

    Taiyuan 1793511, 030032
    China

    Site Not Available

  • Research Site

    Tianjin, 300192
    China

    Active - Recruiting

  • Research Site

    Tianjin 1792947, 300192
    China

    Site Not Available

  • Research Site

    Zhengzhou, 450003
    China

    Active - Recruiting

  • Research Site

    Zhengzhou 1784658, 450003
    China

    Site Not Available

  • Research Site

    Hradec Kralova, 50005
    Czechia

    Active - Recruiting

  • Research Site

    Ostrava, 708 52
    Czechia

    Active - Recruiting

  • Research Site

    Ostrava 3068799, 708 52
    Czechia

    Site Not Available

  • Research Site

    Prague, 140 21
    Czechia

    Active - Recruiting

  • Research Site

    Prague 3067696, 140 21
    Czechia

    Site Not Available

  • Research Site

    Praha, 140 21
    Czechia

    Site Not Available

  • Research Site

    Praha 4, 140 21
    Czechia

    Site Not Available

  • Research Site

    Creteil, 94000
    France

    Site Not Available

  • Research Site

    Créteil, 94000
    France

    Site Not Available

  • Research Site

    Créteil 3022530, 94000
    France

    Site Not Available

  • Research Site

    La Rochelle, 17019
    France

    Site Not Available

  • Research Site

    La Rochelle 3006787, 17019
    France

    Site Not Available

  • Research Site

    La Tronche, 38700
    France

    Site Not Available

  • Research Site

    La Tronche 3006131, 38700
    France

    Site Not Available

  • Research Site

    Montpellier, 34295
    France

    Site Not Available

  • Research Site

    Montpellier 2992166, 34295
    France

    Site Not Available

  • Research Site

    Montpellier cedex 5, 34295
    France

    Site Not Available

  • Research Site

    Nantes, 44093
    France

    Site Not Available

  • Research Site

    Nantes 2990969, 44093
    France

    Site Not Available

  • Research Site

    Nantes cedex 1, 44093
    France

    Site Not Available

  • Research Site

    Paris, 75651
    France

    Site Not Available

  • Research Site

    Paris 2988507, 75651
    France

    Site Not Available

  • Research Site

    Paris Cedex 13, 75651
    France

    Site Not Available

  • Research Site

    Toulouse, 31059
    France

    Site Not Available

  • Research Site

    Toulouse 2972315, 31059
    France

    Site Not Available

  • Research Site

    Berlin, 10117
    Germany

    Active - Recruiting

  • Research Site

    Berlin 2950159, 10117
    Germany

    Site Not Available

  • Research Site

    Erlangen, 91054
    Germany

    Active - Recruiting

  • Research Site

    Erlangen 2929567, 91054
    Germany

    Site Not Available

  • Research Site

    Kiel, 24105
    Germany

    Site Not Available

  • Research Site

    Kiel 2891122, 24105
    Germany

    Site Not Available

  • Research Site

    Lübeck, 23538
    Germany

    Active - Recruiting

  • Research Site

    Lübeck 2875601, 23538
    Germany

    Site Not Available

  • Research Site

    Mainz Am Rhein, 55131
    Germany

    Active - Recruiting

  • Research Site

    Muenster, 48149
    Germany

    Site Not Available

  • Research Site

    Münster, 48149
    Germany

    Active - Recruiting

  • Research Site

    Münster 2867543, 48149
    Germany

    Site Not Available

  • Research Site

    Bologna, 40138
    Italy

    Active - Recruiting

  • Research Site

    Bologna 3181928, 40138
    Italy

    Site Not Available

  • Research Site

    Foligno, 06034
    Italy

    Site Not Available

  • Research Site

    Foligno 3176854, 06034
    Italy

    Site Not Available

  • Research Site

    Milan, 20162
    Italy

    Active - Recruiting

  • Research Site

    Milan 6951411, 20162
    Italy

    Site Not Available

  • Research Site

    Milano, 20162
    Italy

    Site Not Available

  • Research Site

    Padova, 35128
    Italy

    Active - Recruiting

  • Research Site

    Padua, 35128
    Italy

    Site Not Available

  • Research Site

    Padua 3171728, 35128
    Italy

    Site Not Available

  • Research Site

    Parma, 43100
    Italy

    Active - Recruiting

  • Research Site

    Parma 3171457, 43100
    Italy

    Site Not Available

  • Research Site

    Torino, 10126
    Italy

    Active - Recruiting

  • Research Site

    Torino 8980539, 10126
    Italy

    Site Not Available

  • Research Site

    Kyoto, 602-8566
    Japan

    Active - Recruiting

  • Research Site

    Kyoto 1857910, 602-8566
    Japan

    Site Not Available

  • Research Site

    Kyoto-shi, 602-8566
    Japan

    Site Not Available

  • Research Site

    Suita-shi, 565-0871
    Japan

    Active - Recruiting

  • Research Site

    Gyeonggi-do, 13620
    Korea, Republic of

    Site Not Available

  • Research Site

    Seoul, 03080
    Korea, Republic of

    Site Not Available

  • Research Site

    Bydgoszcz, 85-094
    Poland

    Site Not Available

  • Research Site

    Bydgoszcz 3102014, 85-094
    Poland

    Site Not Available

  • Research Site

    Gdansk, 80-214
    Poland

    Active - Recruiting

  • Research Site

    Gdansk 3099434, 80-214
    Poland

    Site Not Available

  • Research Site

    Gdańsk, 80-214
    Poland

    Site Not Available

  • Research Site

    Poznan, 60-355
    Poland

    Active - Recruiting

  • Research Site

    Poznan 3088171, 60-355
    Poland

    Site Not Available

  • Research Site

    Warsaw, 02-091
    Poland

    Site Not Available

  • Research Site

    Warsaw 756135, 02-091
    Poland

    Site Not Available

  • Research Site

    Warszawa, 02-091
    Poland

    Site Not Available

  • Research Site

    Lisboa, 1649-035
    Portugal

    Site Not Available

  • Research Site

    Lisbon, 1649-035
    Portugal

    Site Not Available

  • Research Site

    Lisbon 2267057, 1649-035
    Portugal

    Site Not Available

  • Research Site

    Porto, 4050-313
    Portugal

    Active - Recruiting

  • Research Site

    Porto 2735943, 4200319
    Portugal

    Site Not Available

  • Research Site

    Gyeonggi-do, 13620
    South Korea

    Active - Recruiting

  • Research Site

    Gyeonggi-do 6363696, 13620
    South Korea

    Site Not Available

  • Research Site

    Seoul, 03080
    South Korea

    Active - Recruiting

  • Research Site

    Seoul 1835848, 03722
    South Korea

    Site Not Available

  • Research Site

    Badajoz, 06080
    Spain

    Active - Recruiting

  • Research Site

    Badajoz 2521420, 06080
    Spain

    Site Not Available

  • Research Site

    Barakaldo, 48903
    Spain

    Active - Recruiting

  • Research Site

    Barakaldo 3109453, 48903
    Spain

    Site Not Available

  • Research Site

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Research Site

    Barcelona 3128760, 08036
    Spain

    Site Not Available

  • Research Site

    Cadiz, 11009
    Spain

    Active - Recruiting

  • Research Site

    Cadiz 2520600, 11009
    Spain

    Site Not Available

  • Research Site

    Cádiz, 11009
    Spain

    Site Not Available

  • Research Site

    Córdoba, 14004
    Spain

    Active - Recruiting

  • Research Site

    Córdoba 2519240, 14004
    Spain

    Site Not Available

  • Research Site

    Granada, 18014
    Spain

    Active - Recruiting

  • Research Site

    Granada 2517117, 18014
    Spain

    Site Not Available

  • Research Site

    Madrid, 28041
    Spain

    Active - Recruiting

  • Research Site

    Madrid 3117735, 28041
    Spain

    Site Not Available

  • Research Site

    Málaga, 29010
    Spain

    Active - Recruiting

  • Research Site

    Málaga 2514256, 29010
    Spain

    Site Not Available

  • Research Site

    Valencia, 46017
    Spain

    Active - Recruiting

  • Research Site

    Valencia 2509954, 46017
    Spain

    Site Not Available

  • Research Site

    Zaragoza, 50009
    Spain

    Active - Recruiting

  • Research Site

    Zaragoza 3104324, 50009
    Spain

    Site Not Available

  • Research Site

    Kaohsiung, 833
    Taiwan

    Site Not Available

  • Research Site

    Kaohsiung City, 833
    Taiwan

    Active - Recruiting

  • Research Site

    Kaohsiung City 1673820, 833
    Taiwan

    Site Not Available

  • Research Site

    Taichung, 40447
    Taiwan

    Active - Recruiting

  • Research Site

    Taichung 1668399, 40447
    Taiwan

    Site Not Available

  • Research Site

    Taipei, 110
    Taiwan

    Active - Recruiting

  • Research Site

    Taipei 1668341, 110
    Taiwan

    Site Not Available

  • Research Site

    Taipei City, 110
    Taiwan

    Site Not Available

  • Research Site

    Taoyuan, 333
    Taiwan

    Site Not Available

  • Research Site

    Taoyuan District, 333
    Taiwan

    Site Not Available

  • Research Site

    Taoyuan District 1667905, 333
    Taiwan

    Site Not Available

  • Research Site

    Leeds, LS9 7TF
    United Kingdom

    Active - Recruiting

  • Research Site

    Leeds 2644688, LS9 7TF
    United Kingdom

    Site Not Available

  • Research Site

    London, SE1 9RT
    United Kingdom

    Active - Recruiting

  • Research Site

    London 2643743, SE1 9RT
    United Kingdom

    Site Not Available

  • Research Site

    Woodville South, 5011
    United Kingdom

    Active - Recruiting

  • Research Site

    Phoenix, Arizona 85054
    United States

    Active - Recruiting

  • Research Site

    Phoenix 5308655, Arizona 5551752 85054
    United States

    Site Not Available

  • Research Site

    Los Angeles, California 90095
    United States

    Active - Recruiting

  • Research Site

    San Francisco, California 94143
    United States

    Active - Recruiting

  • Research Site

    Stanford, California 94305
    United States

    Active - Recruiting

  • Research Site

    Los Angeles 5368361, California 5332921 90095
    United States

    Site Not Available

  • Research Site

    San Francisco 5391959, California 5332921 94115
    United States

    Site Not Available

  • Research Site

    Stanford 5398563, California 5332921 94305
    United States

    Site Not Available

  • Research Site

    New Haven, Connecticut 06510
    United States

    Active - Recruiting

  • Research Site

    New Haven 4839366, Connecticut 4831725 06510
    United States

    Site Not Available

  • Research Site

    Jacksonville, Florida 32224
    United States

    Active - Recruiting

  • Research Site

    Tampa, Florida 33606
    United States

    Active - Recruiting

  • Research Site

    Jacksonville 4160021, Florida 4155751 32224
    United States

    Site Not Available

  • Research Site

    Tampa 4174757, Florida 4155751 33606
    United States

    Site Not Available

  • Research Site

    Atlanta, Georgia 30322
    United States

    Active - Recruiting

  • Research Site

    Atlanta 4180439, Georgia 4197000 30322
    United States

    Site Not Available

  • Research Site

    Chicago, Illinois 60608
    United States

    Active - Recruiting

  • Research Site

    Chicago 4887398, Illinois 4896861 60637
    United States

    Site Not Available

  • Research Site

    Fairway, Kansas 66205
    United States

    Active - Recruiting

  • Research Site

    Fairway 4271358, Kansas 4273857 66205
    United States

    Site Not Available

  • Research Site

    Lexington, Kentucky 40508
    United States

    Active - Recruiting

  • Research Site

    Lexington 4297983, Kentucky 6254925 40508
    United States

    Site Not Available

  • Research Site

    Kenner, Louisiana 70065
    United States

    Active - Recruiting

  • Research Site

    Kenner 4329753, Louisiana 4331987 70065
    United States

    Site Not Available

  • Research Site

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

  • Research Site

    Detroit, Michigan 48202
    United States

    Active - Recruiting

  • Research Site

    Ann Arbor 4984247, Michigan 5001836 48109
    United States

    Site Not Available

  • Research Site

    Detroit 4990729, Michigan 5001836 48202
    United States

    Site Not Available

  • Research Site

    Minneapolis, Minnesota 55455
    United States

    Active - Recruiting

  • Research Site

    Minneapolis 5037649, Minnesota 5037779 55455
    United States

    Site Not Available

  • Research Site

    Saint Louis, Missouri 63108
    United States

    Site Not Available

  • Research Site

    St Louis, Missouri 63108
    United States

    Active - Recruiting

  • Research Site

    St Louis 4407066, Missouri 4398678 63108
    United States

    Site Not Available

  • Research Site

    Omaha, Nebraska 68198
    United States

    Active - Recruiting

  • Research Site

    Omaha 5074472, Nebraska 5073708 68198
    United States

    Site Not Available

  • Research Site

    Livingston, New Jersey 07039
    United States

    Active - Recruiting

  • Research Site

    Livingston 5100572, New Jersey 5101760 07039
    United States

    Site Not Available

  • Research Site

    New York, New York 10016
    United States

    Site Not Available

  • Research Site

    New York 5128581, New York 5128638 10016
    United States

    Site Not Available

  • Research Site

    Durham, North Carolina 27705
    United States

    Active - Recruiting

  • Research Site

    Durham 4464368, North Carolina 4482348 27705
    United States

    Site Not Available

  • Research Site

    Philadelphia, Pennsylvania 19140
    United States

    Active - Recruiting

  • Research Site

    Philadelphia 4560349, Pennsylvania 6254927 19140
    United States

    Site Not Available

  • Research Site

    Greenville, South Carolina 29605
    United States

    Active - Recruiting

  • Research Site

    Greenville 4580543, South Carolina 4597040 29605
    United States

    Site Not Available

  • Research Site

    Nashville, Tennessee 37232
    United States

    Active - Recruiting

  • Research Site

    Nashville 4644585, Tennessee 4662168 37232
    United States

    Site Not Available

  • Research Site

    Dallas, Texas 75235
    United States

    Active - Recruiting

  • Research Site

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Research Site

    Dallas 4684888, Texas 4736286 75235
    United States

    Site Not Available

  • Research Site

    Houston 4699066, Texas 4736286 77030
    United States

    Site Not Available

  • Research Site

    Charlottesville, Virginia 22908
    United States

    Active - Recruiting

  • Research Site

    Richmond, Virginia 23298
    United States

    Active - Recruiting

  • Research Site

    Charlottesville 4752031, Virginia 6254928 22908
    United States

    Site Not Available

  • Research Site

    Richmond 4781708, Virginia 6254928 23298
    United States

    Site Not Available

  • Research Site

    Seattle, Washington 98104
    United States

    Active - Recruiting

  • Research Site

    Seattle 5809844, Washington 5815135 98104
    United States

    Site Not Available

  • Research Site

    Milwaukee, Wisconsin 53226
    United States

    Active - Recruiting

  • Research Site

    Milwaukee 5263045, Wisconsin 5279468 53226
    United States

    Site Not Available

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