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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05746559
Other study ID # D928DC00001
Secondary ID ALXN1210-CSA-AKI
Status Recruiting
Phase Phase 3
First received
Last updated
Start date April 6, 2023
Est. completion date May 17, 2026

Study information

Verified date June 2024
Source Alexion Pharmaceuticals, Inc.
Contact Alexion Pharmaceuticals, Inc. (Sponsor)
Phone 1-855-752-2356
Email clinicaltrials@alexion.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary objective of this study is to assess the efficacy of a single dose of ravulizumab IV compared with placebo in reducing the risk of the clinical consequences of AKI (MAKE) at 90 days in adult participants with CKD who undergo non-emergent cardiac surgery with CPB.


Recruitment information / eligibility

Status Recruiting
Enrollment 736
Est. completion date May 17, 2026
Est. primary completion date May 17, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria: - Participant weighs = 30 kg - Planned non-emergent sternotomy with CPB procedure for the following surgeries: - Multi-vessel CABG - Valve replacement or repair; ascending aorta surgery permitted if combined with aortic valve replacement/repair - Combined CABG and valve surgery; inclusion of single-vessel CABG when combined with valve replacement/repair is permitted - Known CKD for at least 90 days (CKD Stage 3A, 3B, or 4) Exclusion Criteria: - Emergency or salvage cardiac surgery is expected at screening or randomization, as assessed by the Investigator. - Single-vessel CABG without valve surgery is planned. - Off-pump surgery is planned (eg, surgery without CPB). - Recipient of a solid organ or bone marrow transplantation. - Cardiogenic shock, hemodynamic instability, use of intra-aortic balloon pump, extracorporeal membrane oxygenation, or left ventricular assist device within 72 hours of randomization. - Active systemic bacterial, viral, or fungal infection within 14 days prior to randomization. - History of unexplained, recurrent infection. - Any use of KRT or presence of AKI within 30 days of randomization - Use of any complement inhibitors, or plasmapheresis or plasma exchange within the year prior to Screening, or planned use during the course of the study. - Participant is not willing to be vaccinated against N meningitidis or is unwilling to receive prophylactic treatment with appropriate antibiotics, if needed - History of or unresolved N meningitidis infection.

Study Design


Intervention

Drug:
Placebo
Participants will receive a single weight-based dose of placebo via intravenous infusion.
Ravulizumab
Participants will receive a single weight-based dose of ravulizumab via intravenous infusion.

Locations

Country Name City State
Argentina Research Site Buenos Aires
Argentina Research Site Caba
Argentina Research Site Ciudad Autónoma de Bs. As.
Argentina Research Site Cordoba
Argentina Research Site Cordoba
Argentina Research Site Córdoba
Argentina Research Site Corrientes
Argentina Research Site San Luis
Argentina Research Site Santa Fé
Australia Research Site Brisbane
Australia Research Site Canberra
Australia Research Site Heidelberg
Australia Research Site Monash
Australia Research Site Murdoch
Australia Research Site Southport
Brazil Research Site Belo Horizonte
Brazil Research Site Campinas
Brazil Research Site Fortaleza
Brazil Research Site Porto Alegre
Brazil Research Site Ribeirão Preto
Brazil Research Site S.J. Do Rio Preto
Brazil Research Site Salvador
Brazil Research Site Sao Paulo
Brazil Research Site Sao Paulo
Brazil Research Site São Paulo
Brazil Research Site São Paulo
Canada Research Site Edmonton Alberta
Canada Research Site Hamilton Ontario
Canada Research Site Kingston Ontario
Canada Research Site Montreal Quebec
Canada Research Site Montreal Quebec
Canada Research Site Montréal Quebec
Canada Research Site Saint John New Brunswick
Canada Research Site Toronto Ontario
China Research Site Fuzhou
China Research Site Gaozhou
China Research Site Guangzhou
China Research Site Hangzhou
China Research Site Hangzhou
China Research Site Ningbo
China Research Site Shanghai
China Research Site Shenzhen
China Research Site Shenzhen
China Research Site Tianjin
China Research Site Wuhan
China Research Site Zhengzhou
China Research Site Zhengzhou
Germany Research Site Dresden
Germany Research Site Essen
Germany Research Site Frankfurt am Main
Germany Research Site Giessen
Germany Research Site Halle (Saale)
Germany Research Site Heidelberg
Germany Research Site Jena
Germany Research Site Muenster
Germany Research Site München
Germany Research Site Stuttgart
Germany Research Site Trier
Hong Kong Research Site Hong Kong
India Research Site Bangalore
India Research Site Bangalore
India Research Site Delhi
India Research Site Gurgaon
India Research Site Hyderabad
India Research Site Mysuru
India Research Site Secunderabad
Israel Research Site Haifa
Israel Research Site Haifa
Israel Research Site Petah Tikva
Israel Research Site Ramat Gan
Italy Research Site Bari
Italy Research Site Milan
Italy Research Site Milano
Italy Research Site Napoli
Japan Research Site Bunkyo-ku
Japan Research Site Chuo-ku
Japan Research Site Kamakura-shi
Japan Research Site Kawasaki-shi
Japan Research Site Minato-ku
Japan Research Site Okayama-shi
Japan Research Site Sagamihara-shi
Japan Research Site Suginami
Japan Research Site Urayasu
Korea, Republic of Research Site Anyang-si
Korea, Republic of Research Site Busan
Korea, Republic of Research Site Daegu
Korea, Republic of Research Site Daegu
Korea, Republic of Research Site Seongnam-si
Korea, Republic of Research Site Seoul
Korea, Republic of Research Site Seoul
Korea, Republic of Research Site Seoul
Korea, Republic of Research Site Seoul
Netherlands Research Site Groningen
Netherlands Research Site Maastricht
Netherlands Research Site Rotterdam
Poland Research Site Bielsko-Biala
Poland Research Site Chrzanów
Poland Research Site Grudziadz
Poland Research Site Katowice
Poland Research Site Kraków
Poland Research Site Lódz
Poland Research Site Lódz
Poland Research Site Poznan
Poland Research Site Szczecin
Poland Research Site Tychy
Poland Research Site Warszawa
Spain Research Site A Coruna
Spain Research Site Barcelona
Spain Research Site Barcelona
Spain Research Site Córdoba
Spain Research Site Madrid
Spain Research Site Madrid
Spain Research Site Majadahonda
Spain Research Site Navarra
Spain Research Site Santander
Spain Research Site Sevilla
Spain Research Site Valencia
Spain Research Site Valladolid
Taiwan Research Site Hualien City
Taiwan Research Site New Taipei
Taiwan Research Site Taichung
Taiwan Research Site Tainan City
Taiwan Research Site Taipei City
Turkey Research Site Ankara
Turkey Research Site Istanbul
Turkey Research Site Istanbul
Turkey Research Site Istanbul
Turkey Research Site Istanbul
Turkey Research Site Istanbul
United Kingdom Research Site Cambridge
United Kingdom Research Site Clydebank
United Kingdom Research Site Edinburgh
United Kingdom Research Site London
United Kingdom Research Site London
United Kingdom Research Site London
United Kingdom Research Site Newcastle upon Tyne
United States Research Site Atlanta Georgia
United States Research Site Aurora Colorado
United States Research Site Boston Massachusetts
United States Research Site Charleston South Carolina
United States Research Site Charlottesville Virginia
United States Research Site Chicago Illinois
United States Research Site Cleveland Ohio
United States Research Site Cleveland Ohio
United States Research Site Columbus Ohio
United States Research Site Dallas Texas
United States Research Site Detroit Michigan
United States Research Site Durham North Carolina
United States Research Site Fargo North Dakota
United States Research Site Fort Wayne Indiana
United States Research Site Gainesville Florida
United States Research Site Haddon Heights New Jersey
United States Research Site Houston Texas
United States Research Site Indianapolis Indiana
United States Research Site Kansas City Missouri
United States Research Site Lincoln Nebraska
United States Research Site Louisville Kentucky
United States Research Site Orange California
United States Research Site Orlando Florida
United States Research Site Philadelphia Pennsylvania
United States Research Site Philadelphia Pennsylvania
United States Research Site Philadelphia Pennsylvania
United States Research Site Plano Texas
United States Research Site Richmond Virginia
United States Research Site Rochester New York
United States Research Site Saint Louis Missouri
United States Research Site Salt Lake City Utah
United States Research Site San Antonio Texas
United States Research Site San Francisco California
United States Research Site San Francisco California
United States Research Site Seattle Washington
United States Research Site Springfield Massachusetts
United States Research Site Stanford California
United States Research Site Tacoma Washington
United States Research Site Tucson Arizona
United States Research Site Valhalla New York
United States Research Site Washington District of Columbia
United States Research Site Wisconsin Rapids Wisconsin

Sponsors (1)

Lead Sponsor Collaborator
Alexion Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Brazil,  Canada,  China,  Germany,  Hong Kong,  India,  Israel,  Italy,  Japan,  Korea, Republic of,  Netherlands,  Poland,  Spain,  Taiwan,  Turkey,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants Experiencing Major Adverse Kidney Events (MAKE) (Based on serum Cystatin C [sCysC]) at Day 90 Post Cardiopulmonary Bypass (CPB) Day 90 post-CPB
Secondary Number of Participants Free From Cardiac Surgery-Associated Acute Kidney Injury (CSA-AKI) at Day 90 Post CPB Day 90 post-CPB
Secondary Number of Participants Free From Severe CSA-AKI (Kidney Disease: Improving Global Outcomes [KDIGO] Stage 2 or 3) Based on Highest Observed Serum Creatinine (sCr) Within 7 Days Post CPB Baseline through Day 7 post-CPB
Secondary Number of Participants Free From Any Severe Acute Kidney Injury (AKI) (Risk, Injury, Failure, Loss of Kidney Function, and End-Stage Kidney Disease [RIFLE] Injury or Failure Criteria) Based on Highest Observed sCr Within Day 30 Post CPB Baseline through Day 30 post-CPB
Secondary Number of Participants Free From Any Severe AKI (KDIGO Stage 2 or 3) Based on Highest Observed sCr Within Day 30 Post CPB Baseline through Day 30 post-CPB
Secondary Number of Participants Free From Any RIFLE Failure Criteria Based on Highest Observed sCr Within Day 30 Post CPB Baseline through Day 30 post-CPB
Secondary Number of Participants Who Experienced MAKE at Days 30, 60, and 90 (Excluding MAKE90 Based on sCysC) Post CPB Days 30, 60, and 90 post-CPB
Secondary Number of Participants Who Died or had Kidney Replacement Therapy (KRT) at Days 30, 60, and 90 Post CPB Days 30, 60, and 90 post-CPB
Secondary Number of Participants with the Highest CSA-AKI Stage Within 3 and 7 Days Post CPB Baseline through Day 3 and Day 7 post-CPB
Secondary Number of Participants Free From CSA-AKI at Days 15, 30, and 60 Post CPB Days 15, 30, and 60 post-CPB
Secondary Number of Participants Free From Any AKI at Days 3, 7, 15, 30, 60, and 90 Post CPB Days 3, 7, 15, 30, 60, and 90 post-CPB
Secondary Number of Participants with AKI Progression on Days 15, 30, 60, and 90 Post CPB for Those Experiencing CSA-AKI Within 7 Days Post CPB Days 15, 30, 60, and 90 post-CPB
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