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 - ARTEMIS

Yokosawa Jun0 个研究点目标入组 36 人开始时间: 2023年4月16日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•1. Participant weighs 30 kg more
•2. 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 or repair
•Combined CABG and valve surgery, inclusion of single-vessel CABG when combined with valve replacement or repair is permitted
•3. Known CKD (Stage 3A, 3B, or 4) for at least 3 months

•1. Emergency or salvage cardiac surgery is expected at screening or randomization, as assessed by the Investigator.
•2. Single-vessel CABG without valve surgery is planned.
•3. Off-pump surgery is planned (eg, surgery without CPB).
•4. Recipient of a solid organ or bone marrow transplantation.
•5. Cardiogenic shock, hemodynamic instability, use of intra-aortic balloon pump, extracorporeal membrane oxygenation, or left ventricular assist device within 72 hours of randomization.
•6. Active systemic bacterial, viral, or fungal infection within 14 days prior to randomization.
•7. History of unexplained, recurrent infection.
•8. Any use of KRT or presence of AKI within 30 days of randomization
•9. 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.
•10. Participant is not willing to be vaccinated against N meningitidis or is unwilling to receive prophylactic treatment with appropriate antibiotics, if needed
•11. History of or unresolved N meningitidis infection.

发起方

Yokosawa Jun