ARTEMIS
Research type
Research Study
Full title
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
IRAS ID
1007019
Contact name
Fay Kurt
Contact email
Sponsor organisation
Alexion Pharmaceuticals, Inc.
Clinicaltrials.gov Identifier
Research summary
Acute kidney injury (AKI) is a complication after open heart surgery (surgery with heart/lung pump; also called cardiopulmonary bypass or CPB). Inflammation during and after surgery can damage the kidneys. Patients with chronic kidney disease (CKD) are at increased risk for AKI after open heart surgery. Long-term effects of AKI, called major adverse kidney events (MAKE), include death, new need for dialysis, and worse kidney function (worse CKD). This study looks at a study drug, called ravulizumab which blocks inflammation caused by the immune system. To learn more about the study drug, it will be compared with a placebo. Assessments that will be performed in the study include questionnaires, physical examinations, vital signs, blood tests, urine tests, pregnancy tests and vaccinations. The study will have four periods. A screening period, a dosing period, a primary evaluation period and a follow up period. The study duration will be approximately 400 days.
REC name
London - South East Research Ethics Committee
REC reference
22/LO/0926
Date of REC Opinion
9 Feb 2023
REC opinion
Further Information Favourable Opinion