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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05746559




Registration number
NCT05746559
Ethics application status
Date submitted
16/02/2023
Date registered
27/02/2023

Titles & IDs
Public title
ARTEMIS: Ravulizumab to Protect Patients With CKD From CSA-AKI and MAKE
Scientific 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
Secondary ID [1] 0 0
ALXN1210-CSA-AKI-318
Secondary ID [2] 0 0
D928DC00001
Universal Trial Number (UTN)
Trial acronym
ARTEMIS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Kidney Disease 0 0
CKD 0 0
Cardiac Disease 0 0
Cardiopulmonary Bypass 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - Ravulizumab

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

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


Treatment: Drugs: Placebo
Participants will receive a single weight-based dose of placebo via intravenous infusion.

Treatment: Drugs: Ravulizumab
Participants will receive a single weight-based dose of ravulizumab via intravenous infusion.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants Experiencing Major Adverse Kidney Events (MAKE) (Based on serum Cystatin C [sCysC]) at Day 90 Post Cardiopulmonary Bypass (CPB)
Timepoint [1] 0 0
Day 90 post-CPB
Secondary outcome [1] 0 0
Number of Participants Free From Cardiac Surgery-Associated Acute Kidney Injury (CSA-AKI) at Day 90 Post CPB
Timepoint [1] 0 0
Day 90 post-CPB
Secondary outcome [2] 0 0
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
Timepoint [2] 0 0
Baseline through Day 7 post-CPB
Secondary outcome [3] 0 0
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
Timepoint [3] 0 0
Baseline through Day 30 post-CPB
Secondary outcome [4] 0 0
Number of Participants Free From Any Severe AKI (KDIGO Stage 2 or 3) Based on Highest Observed sCr Within Day 30 Post CPB
Timepoint [4] 0 0
Baseline through Day 30 post-CPB
Secondary outcome [5] 0 0
Number of Participants Free From Any RIFLE Failure Criteria Based on Highest Observed sCr Within Day 30 Post CPB
Timepoint [5] 0 0
Baseline through Day 30 post-CPB
Secondary outcome [6] 0 0
Number of Participants Who Experienced MAKE at Days 30, 60, and 90 (Excluding MAKE90 Based on sCysC) Post CPB
Timepoint [6] 0 0
Days 30, 60, and 90 post-CPB
Secondary outcome [7] 0 0
Number of Participants Who Died or had Kidney Replacement Therapy (KRT) at Days 30, 60, and 90 Post CPB
Timepoint [7] 0 0
Days 30, 60, and 90 post-CPB
Secondary outcome [8] 0 0
Number of Participants with the Highest CSA-AKI Stage Within 3 and 7 Days Post CPB
Timepoint [8] 0 0
Baseline through Day 3 and Day 7 post-CPB
Secondary outcome [9] 0 0
Number of Participants Free From CSA-AKI at Days 15, 30, and 60 Post CPB
Timepoint [9] 0 0
Days 15, 30, and 60 post-CPB
Secondary outcome [10] 0 0
Number of Participants Free From Any AKI at Days 3, 7, 15, 30, 60, and 90 Post CPB
Timepoint [10] 0 0
Days 3, 7, 15, 30, 60, and 90 post-CPB
Secondary outcome [11] 0 0
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
Timepoint [11] 0 0
Days 15, 30, 60, and 90 post-CPB

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/04/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
17/05/2026
Actual
Sample size
Target
736
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Brisbane
Recruitment hospital [2] 0 0
Research Site - Heidelberg
Recruitment hospital [3] 0 0
Research Site - Monash
Recruitment hospital [4] 0 0
Research Site - Murdoch
Recruitment hospital [5] 0 0
Research Site - Southport
Recruitment postcode(s) [1] 0 0
4102 - Brisbane
Recruitment postcode(s) [2] 0 0
3081 - Heidelberg
Recruitment postcode(s) [3] 0 0
- Monash
Recruitment postcode(s) [4] 0 0
6150 - Murdoch
Recruitment postcode(s) [5] 0 0
4215 - Southport
Recruitment outside Australia
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Istanbul
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Clydebank
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Edinburgh
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London
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Newcastle upon Tyne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Alexion Pharmaceuticals, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Alexion Pharmaceuticals, Inc. (Sponsor)
Address 0 0
Country 0 0
Phone 0 0
1-855-752-2356
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Alexion has a public commitment to allow requests for access to study data and will be supplying a protocol, CSR, and plain language summaries.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05746559