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
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 736
- 试验地点
- 7
- 主要终点
- To assess the efficacy of ravulizumab in reducing risk of MAKE90 following CPB
研究概览
简要总结
This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter study of ravulizumab in adult participants with CKD and stable cardiac disease undergoing non-emergent sternotomy with CPB for coronary artery bypass graft (CABG), valve replacement or repair, or combined procedure, to reduce the risk of post-operative AKI and subsequent MAKE at 90 days after surgery. Participants considered at risk for AKI after CPB have estimated glomerular filtration rate (eGFR) ≥ 20 to < 60 mL/min/1.73 m2 with minimum Society of Thoracic Surgeons (STS) Calculator Renal Failure Risk Score of 2.8%.
The study consists of a Screening Period of up to 28 days with Randomization and Dosing within 1 to 7 days prior to surgery with CPB, a 90-day Primary Evaluation Period post CPB, and a Survival Follow-up including assessment of KRT status at 365 days post CPB.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Greater than or equal to 18 to less than or equal to 90 years of age at the time of signing the informed consent.
- •Male or female.
- •Body weight greater than or equal 30 kg at Screening.
- •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.
- •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
- •At risk for postsurgical AKI as defined by a minimum STS Calculator Renal Failure Risk Score of 3 percentage assessed at time of screening.
- •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
- •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).
- •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
- •Recipient of a solid organ or bone marrow transplantation.
- •Cardiogenic shock, hemodynamic instability, use of intra-aortic balloon pump (IABP), 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.
- •Congenital immunodeficiency.
- •History of unexplained, recurrent infection.
- •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.
- •Hypersensitivity to any ingredient contained in the study intervention, including hypersensitivity to murine proteins.
- •Current malignancy or receiving treatment for malignancy except for non-melanoma skin cancer.
- •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
- •Planned use of KRT, IABP, extracorporeal membrane oxygenation, or left ventricular assist device between randomization and surgery.
- •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.
- •Presence of a do-not-resuscitate order or life expectancy of less than 3 months
- •Pregnant, breastfeeding, or intending to conceive within 8 months after the dose of study intervention.
- •Participant is not willing to be vaccinated against N meningitidis or is unwilling to receive prophylactic treatment with appropriate antibiotics.
结局指标
主要结局
To assess the efficacy of ravulizumab in reducing risk of MAKE90 following CPB
时间窗: To assess the efficacy of ravulizumab in reducing risk of MAKE90 following CPB at DAY 90 post CPB.
Adult participants with CKD as defined by the inclusion and exclusion criteria
时间窗: To assess the efficacy of ravulizumab in reducing risk of MAKE90 following CPB at DAY 90 post CPB.
次要结局
- Immunogenicity
- Safety:
- To assess the efficacy of ravulizumab in reducing risk of AKI (based on sCr) following CPB(1) CSA-AKI free at Day 90 post CPB)
- Other Secondary Efficacy(To assess the efficacy of ravulizumab in reducing risk of MAKE, MAKE (based on sCr), AKI (based on sCr), and related outcomes)
- Other Secondary Efficacy(To assess the efficacy of ravulizumab in reducing risk of MAKE, MAKE (based on sCr), AKI (based on sCr), and related outcomes contd..)
- Healthcare Resource Utilization
- Health-related QoL(To assess the effect of ravulizumab on quality of life in participants with CKD undergoing non-emergent CPB.)
- PK and PD(To evaluate PK and PD of ravulizumab in participants with CKD undergoing non-emergent CPB)
- Exploratory(To assess biomarkers at baseline and change in response to treatment)
研究者
Dr Santosh Kadam
AstraZeneca Pharma India Ltd.
研究点 (7)
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