CTRI/2024/05/067786尚未招募3 期
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
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Greater than or equal to 18 to less than or equal to 90 years of age at the time of signing the informed consent.
- •2.Male or female.
- •3.Body weight greater than or equal 30 kg at Screening.
- •4.Planned non-emergent sternotomy with CPB procedure for the following surgeries
- •i. Multi-vessel CABG
- •ii. Valve replacement or repair; ascending aorta surgery permitted if combined with aortic valve replacement or repair
- •iii. Combined CABG and valve surgery; inclusion of single-vessel CABG when combined with valve replacement or repair is permitted.
- •5.Known CKD for at least 90 days with eGFR Greaterthan or equal to 20 to less than 60 mL min 1.73 m2 CKD Stage 3A, 3B, or 4 at Screening
- •6.At risk for postsurgical AKI as defined by a minimum STS Calculator Renal Failure Risk Score of 3 percentage assessed at time of screening.
- •7.Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol
排除标准
- •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.Any use of KRT or presence of AKI within 30 days of randomization (AKI defined as 1.5× increase in sCr over baseline), except transient (less than or equal to 5 days) Stage 1 AKI after iodinated contrast exposure
- •5.Recipient of a solid organ or bone marrow transplantation.
- •6.Cardiogenic shock, hemodynamic instability, use of intra-aortic balloon pump (IABP), extracorporeal membrane oxygenation, or left ventricular assist device within 72 hours of randomization.
- •7.Active systemic bacterial, viral, or fungal infection within 14 days prior to randomization.
- •8.Participants with history of human immunodeficiency virus (HIV) who are not on anti- retroviral therapy or if on therapy have a known detectable viral load within 1 year of Screening
- •9.Congenital immunodeficiency.
- •10.History of unexplained, recurrent infection.
- •11.Known medical or psychological condition(s), including substance abuse, or risk factor that, in the opinion of the Investigator, might interfere with the participant s full participation in the study, pose any additional risk for the participant, or confound the assessment of the participant or outcome of the study.
- •12.History of, or unresolved, N meningitidis infection.
- •13.Hypersensitivity to any ingredient contained in the study intervention, including hypersensitivity to murine proteins.
- •14.Current malignancy or receiving treatment for malignancy except for non-melanoma skin cancer.
- •15.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
- •16.Planned use of any pharmacologic agent specifically for prevention or treatment of AKI
- •17.Planned use of KRT, IABP, extracorporeal membrane oxygenation, or left ventricular assist device between randomization and surgery.
- •18.Participation in another interventional treatment study or use of any experimental therapy within 30 days before initiation of study intervention on Day 1 in this study or within 5 half lives of that IP, whichever is greater, or planned participation use during the course of the study.
- •19.Presence of a do-not-resuscitate order or life expectancy of less than 3 months
- •20.Pregnant, breastfeeding, or intending to conceive within 8 months after the dose of study intervention.
- •21.Participant is not willing to be vaccinated against N meningitidis or is unwilling to receive prophylactic treatment with appropriate antibiotics
研究者
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