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ARTEMIS: Ravulizumab to Protect Patients With CKD From CSA-AKI and MAKE (ARTEMIS)

Primary Purpose

Chronic Kidney Disease, CKD, Cardiac Disease

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Placebo
Ravulizumab
Sponsored by
Alexion
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease focused on measuring Chronic Kidney Disease, CKD, Cardiac Disease, cardiopulmonary bypass

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

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Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Ravulizumab

Arm Description

Participants will receive a single weight-based dose of placebo via intravenous infusion, 1 to 7 days prior to surgery.

Participants will receive a single weight-based dose of ravulizumab, via intravenous infusion, 1 to 7 days prior to surgery.

Outcomes

Primary Outcome Measures

Number of Participants Experiencing Major Adverse Kidney Events (MAKE) (Based on serum Cystatin C [sCysC]) at Day 90 Post Cardiopulmonary Bypass (CPB)

Secondary Outcome Measures

Number of Participants Free From Cardiac Surgery-Associated Acute Kidney Injury (CSA-AKI) at Day 90 Post CPB
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
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
Number of Participants Free From Any Severe AKI (KDIGO Stage 2 or 3) Based on Highest Observed sCr Within Day 30 Post CPB
Number of Participants Free From Any RIFLE Failure Criteria Based on Highest Observed sCr Within Day 30 Post CPB
Number of Participants Who Experienced MAKE at Days 30, 60, and 90 (Excluding MAKE90 Based on sCysC) Post CPB
Number of Participants Who Died or had Kidney Replacement Therapy (KRT) at Days 30, 60, and 90 Post CPB
Number of Participants with the Highest CSA-AKI Stage Within 3 and 7 Days Post CPB
Number of Participants Free From CSA-AKI at Days 15, 30, and 60 Post CPB
Number of Participants Free From Any AKI at Days 3, 7, 15, 30, 60, and 90 Post CPB
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

Full Information

First Posted
February 16, 2023
Last Updated
October 6, 2023
Sponsor
Alexion
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1. Study Identification

Unique Protocol Identification Number
NCT05746559
Brief Title
ARTEMIS: Ravulizumab to Protect Patients With CKD From CSA-AKI and MAKE
Acronym
ARTEMIS
Official Title
ARTEMIS: RAvulizumab to PRotect PaTients With Chronic Kidney DisEase (CKD) froM Cardiac Surgery Associated Acute Kidney Injury (CSA-AKI) and Subsequent Major Adverse Kidney Events (MAKE): A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 6, 2023 (Actual)
Primary Completion Date
February 27, 2025 (Anticipated)
Study Completion Date
February 27, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alexion

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, CKD, Cardiac Disease, Cardiopulmonary Bypass
Keywords
Chronic Kidney Disease, CKD, Cardiac Disease, cardiopulmonary bypass

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
736 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive a single weight-based dose of placebo via intravenous infusion, 1 to 7 days prior to surgery.
Arm Title
Ravulizumab
Arm Type
Experimental
Arm Description
Participants will receive a single weight-based dose of ravulizumab, via intravenous infusion, 1 to 7 days prior to surgery.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Participants will receive a single weight-based dose of placebo via intravenous infusion.
Intervention Type
Drug
Intervention Name(s)
Ravulizumab
Intervention Description
Participants will receive a single weight-based dose of ravulizumab via intravenous infusion.
Primary Outcome Measure Information:
Title
Number of Participants Experiencing Major Adverse Kidney Events (MAKE) (Based on serum Cystatin C [sCysC]) at Day 90 Post Cardiopulmonary Bypass (CPB)
Time Frame
Day 90 post-CPB
Secondary Outcome Measure Information:
Title
Number of Participants Free From Cardiac Surgery-Associated Acute Kidney Injury (CSA-AKI) at Day 90 Post CPB
Time Frame
Day 90 post-CPB
Title
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
Time Frame
Baseline through Day 7 post-CPB
Title
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
Time Frame
Baseline through Day 30 post-CPB
Title
Number of Participants Free From Any Severe AKI (KDIGO Stage 2 or 3) Based on Highest Observed sCr Within Day 30 Post CPB
Time Frame
Baseline through Day 30 post-CPB
Title
Number of Participants Free From Any RIFLE Failure Criteria Based on Highest Observed sCr Within Day 30 Post CPB
Time Frame
Baseline through Day 30 post-CPB
Title
Number of Participants Who Experienced MAKE at Days 30, 60, and 90 (Excluding MAKE90 Based on sCysC) Post CPB
Time Frame
Days 30, 60, and 90 post-CPB
Title
Number of Participants Who Died or had Kidney Replacement Therapy (KRT) at Days 30, 60, and 90 Post CPB
Time Frame
Days 30, 60, and 90 post-CPB
Title
Number of Participants with the Highest CSA-AKI Stage Within 3 and 7 Days Post CPB
Time Frame
Baseline through Day 3 and Day 7 post-CPB
Title
Number of Participants Free From CSA-AKI at Days 15, 30, and 60 Post CPB
Time Frame
Days 15, 30, and 60 post-CPB
Title
Number of Participants Free From Any AKI at Days 3, 7, 15, 30, 60, and 90 Post CPB
Time Frame
Days 3, 7, 15, 30, 60, and 90 post-CPB
Title
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
Time Frame
Days 15, 30, 60, and 90 post-CPB

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
AstraZeneca Clinical Study Information Center
Phone
1-877-240-9479
Email
information.center@astrazeneca.com
Facility Information:
Facility Name
Research Site
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States
Individual Site Status
Not yet recruiting
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Research Site
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
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United States
Individual Site Status
Not yet recruiting
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City
Stanford
State/Province
California
ZIP/Postal Code
94305
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United States
Individual Site Status
Not yet recruiting
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Research Site
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037-2342
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United States
Individual Site Status
Not yet recruiting
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Research Site
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
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United States
Individual Site Status
Recruiting
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Research Site
City
Fort Wayne
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Indiana
ZIP/Postal Code
46804
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United States
Individual Site Status
Not yet recruiting
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Research Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
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United States
Individual Site Status
Withdrawn
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Research Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
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United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
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United States
Individual Site Status
Not yet recruiting
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Research Site
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
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United States
Individual Site Status
Not yet recruiting
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Research Site
City
Lincoln
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Nebraska
ZIP/Postal Code
68506
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United States
Individual Site Status
Not yet recruiting
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Research Site
City
Haddon Heights
State/Province
New Jersey
ZIP/Postal Code
08035
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United States
Individual Site Status
Withdrawn
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City
Rochester
State/Province
New York
ZIP/Postal Code
14621
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United States
Individual Site Status
Not yet recruiting
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Valhalla
State/Province
New York
ZIP/Postal Code
10595
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United States
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Not yet recruiting
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City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
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United States
Individual Site Status
Withdrawn
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Research Site
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58102
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United States
Individual Site Status
Not yet recruiting
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Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
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United States
Individual Site Status
Not yet recruiting
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Cleveland
State/Province
Ohio
ZIP/Postal Code
44126
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United States
Individual Site Status
Not yet recruiting
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Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
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United States
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Not yet recruiting
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Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
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United States
Individual Site Status
Not yet recruiting
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Dallas
State/Province
Texas
ZIP/Postal Code
75390
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United States
Individual Site Status
Not yet recruiting
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Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Individual Site Status
Withdrawn
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Research Site
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Individual Site Status
Not yet recruiting
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Research Site
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
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United States
Individual Site Status
Not yet recruiting
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Wisconsin Rapids
State/Province
Wisconsin
ZIP/Postal Code
54494
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United States
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City
Buenos Aires
ZIP/Postal Code
C1110 AAF
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Argentina
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Not yet recruiting
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City
Caba
ZIP/Postal Code
C1428DCO
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Argentina
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Not yet recruiting
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City
Ciudad Autónoma de Bs. As.
ZIP/Postal Code
C1199ABB
Country
Argentina
Individual Site Status
Not yet recruiting
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City
Cordoba
ZIP/Postal Code
X5000 FAL
Country
Argentina
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Not yet recruiting
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City
Cordoba
ZIP/Postal Code
X5016
Country
Argentina
Individual Site Status
Withdrawn
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City
Corrientes
ZIP/Postal Code
W3400AMZ
Country
Argentina
Individual Site Status
Not yet recruiting
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City
San Luis
ZIP/Postal Code
5700
Country
Argentina
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Not yet recruiting
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City
Santa Fé
ZIP/Postal Code
S3000EOM
Country
Argentina
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Not yet recruiting
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City
Brisbane
ZIP/Postal Code
4102
Country
Australia
Individual Site Status
Recruiting
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City
Canberra
ZIP/Postal Code
2605
Country
Australia
Individual Site Status
Recruiting
Facility Name
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City
Heidelberg
ZIP/Postal Code
3081
Country
Australia
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Monash
Country
Australia
Individual Site Status
Recruiting
Facility Name
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City
Murdoch
ZIP/Postal Code
6150
Country
Australia
Individual Site Status
Recruiting
Facility Name
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City
Southport
ZIP/Postal Code
4215
Country
Australia
Individual Site Status
Not yet recruiting
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Research Site
City
Belo Horizonte
ZIP/Postal Code
30150-221
Country
Brazil
Individual Site Status
Recruiting
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Research Site
City
Campinas
ZIP/Postal Code
13060-080
Country
Brazil
Individual Site Status
Recruiting
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Research Site
City
Fortaleza
ZIP/Postal Code
60430-375
Country
Brazil
Individual Site Status
Recruiting
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City
Porto Alegre
ZIP/Postal Code
90620-001
Country
Brazil
Individual Site Status
Recruiting
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City
Ribeirão Preto
ZIP/Postal Code
14051-140
Country
Brazil
Individual Site Status
Recruiting
Facility Name
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City
S.J. Do Rio Preto
ZIP/Postal Code
15090-000
Country
Brazil
Individual Site Status
Recruiting
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City
Salvador
ZIP/Postal Code
40301-155
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Sao Paulo
ZIP/Postal Code
01321-001
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Sao Paulo
ZIP/Postal Code
05403-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Sao Paulo
ZIP/Postal Code
1323001
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
São Paulo
ZIP/Postal Code
04012-180
Country
Brazil
Individual Site Status
Recruiting
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City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Individual Site Status
Not yet recruiting
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City
Saint John
State/Province
New Brunswick
ZIP/Postal Code
E2L 4L4
Country
Canada
Individual Site Status
Not yet recruiting
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Research Site
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 8E7
Country
Canada
Individual Site Status
Recruiting
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Research Site
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 2V7
Country
Canada
Individual Site Status
Not yet recruiting
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Research Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Individual Site Status
Recruiting
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Research Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 0C1
Country
Canada
Individual Site Status
Not yet recruiting
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Research Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4J 1C5
Country
Canada
Individual Site Status
Not yet recruiting
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Research Site
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H1T 1C8
Country
Canada
Individual Site Status
Not yet recruiting
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Research Site
City
Fuzhou
ZIP/Postal Code
350001
Country
China
Individual Site Status
Not yet recruiting
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Research Site
City
Gaozhou
ZIP/Postal Code
525232
Country
China
Individual Site Status
Not yet recruiting
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Research Site
City
Guangzhou
ZIP/Postal Code
510120
Country
China
Individual Site Status
Not yet recruiting
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Research Site
City
Hangzhou
ZIP/Postal Code
310014
Country
China
Individual Site Status
Not yet recruiting
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City
Hangzhou
Country
China
Individual Site Status
Not yet recruiting
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City
Ningbo
ZIP/Postal Code
315100
Country
China
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Not yet recruiting
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Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Not yet recruiting
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Shenzhen
ZIP/Postal Code
518036
Country
China
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Not yet recruiting
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City
Shenzhen
ZIP/Postal Code
518053
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China
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Not yet recruiting
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Tianjin
ZIP/Postal Code
300052
Country
China
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Not yet recruiting
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Research Site
City
Wuhan
ZIP/Postal Code
430071
Country
China
Individual Site Status
Withdrawn
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Research Site
City
Zhengzhou
ZIP/Postal Code
450007
Country
China
Individual Site Status
Not yet recruiting
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Research Site
City
Zhengzhou
Country
China
Individual Site Status
Not yet recruiting
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Research Site
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Withdrawn
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Research Site
City
Essen
ZIP/Postal Code
45147
Country
Germany
Individual Site Status
Recruiting
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Research Site
City
Frankfurt am Main
ZIP/Postal Code
60590
Country
Germany
Individual Site Status
Recruiting
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Research Site
City
Giessen
ZIP/Postal Code
35392
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Germany
Individual Site Status
Recruiting
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Research Site
City
Halle (Saale)
ZIP/Postal Code
06120
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Germany
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Recruiting
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Research Site
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Heidelberg
ZIP/Postal Code
69120
Country
Germany
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Not yet recruiting
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Research Site
City
Jena
ZIP/Postal Code
07747
Country
Germany
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Not yet recruiting
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Research Site
City
Muenster
ZIP/Postal Code
48149
Country
Germany
Individual Site Status
Withdrawn
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Research Site
City
München
ZIP/Postal Code
81377
Country
Germany
Individual Site Status
Not yet recruiting
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Research Site
City
Trier
ZIP/Postal Code
54292
Country
Germany
Individual Site Status
Not yet recruiting
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Research Site
City
Hong Kong
Country
Hong Kong
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Individual Site Status
Recruiting
Facility Name
Research Site
City
Haifa
ZIP/Postal Code
34362
Country
Israel
Individual Site Status
Recruiting
Facility Name
Research Site
City
Petah Tikva
ZIP/Postal Code
4941492
Country
Israel
Individual Site Status
Recruiting
Facility Name
Research Site
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Bari
ZIP/Postal Code
70124
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Milano
ZIP/Postal Code
20121
Country
Italy
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Milan
ZIP/Postal Code
20138
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Bunkyo-ku
ZIP/Postal Code
113-8431
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Chuo-ku
ZIP/Postal Code
104-8560
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kamakura-shi
ZIP/Postal Code
247-8533
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kawasaki-shi
ZIP/Postal Code
216-8511
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Minato-ku
ZIP/Postal Code
105-8470
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Okayama-shi
ZIP/Postal Code
700-0804
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Sagamihara-shi
ZIP/Postal Code
252-0375
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Suginami
ZIP/Postal Code
168-0065
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Urayasu
ZIP/Postal Code
279-0001
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Anyang-si
ZIP/Postal Code
14068
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site
City
Busan
ZIP/Postal Code
49241
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Daegu
ZIP/Postal Code
42472
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site
City
Daegu
ZIP/Postal Code
42601
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site
City
Seongnam-si
ZIP/Postal Code
13620
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
02841
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Rotterdam
ZIP/Postal Code
3015 GD
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Bielsko-Biała
ZIP/Postal Code
43-316
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Chrzanów
ZIP/Postal Code
32-500
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Lodz
ZIP/Postal Code
91-347
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Poznań
ZIP/Postal Code
60-355
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Szczecin
ZIP/Postal Code
70-111
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Tychy
ZIP/Postal Code
43-100
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Łódź
ZIP/Postal Code
92-213
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
A Coruna
ZIP/Postal Code
15006
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Barcelona
ZIP/Postal Code
8035
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Majadahonda
ZIP/Postal Code
28250
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Navarra
ZIP/Postal Code
31190
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Santander
ZIP/Postal Code
39008
Country
Spain
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Sevilla
ZIP/Postal Code
41071
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Valladolid
ZIP/Postal Code
47003
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Hualien City
ZIP/Postal Code
970473
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
New Taipei
ZIP/Postal Code
220
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Tainan City
ZIP/Postal Code
70403
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Taipei City
ZIP/Postal Code
11696
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Ankara
ZIP/Postal Code
06800
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Research Site
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Istanbul
ZIP/Postal Code
34303
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Istanbul
ZIP/Postal Code
34349
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Istanbul
ZIP/Postal Code
34668
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Istanbul
ZIP/Postal Code
34846
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Cambridge
ZIP/Postal Code
CB2 0AY
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Clydebank
ZIP/Postal Code
G81 4DY
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Edinburgh
ZIP/Postal Code
EH16 4SA
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
London
ZIP/Postal Code
SW17 0QT
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
London
ZIP/Postal Code
W12 0HS
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Research Site
City
Newcastle upon Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Individual Site Status
Not yet recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Alexion has a public commitment to allow requests for access to study data and will be supplying a protocol, CSR, and plain language summaries.

Learn more about this trial

ARTEMIS: Ravulizumab to Protect Patients With CKD From CSA-AKI and MAKE

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