2022-501802-36-00招募中3 期
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
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 256
- 试验地点
- 47
- 主要终点
- MAKE90 defined as meeting at least 1 of the following criteria: o Decrease from baseline in eGFR (CKD-EPI formula using sCysC) of ≥ 25% at Day 90 post CPB, or o Initiation of KRT through Day 90 post CPB, or o Death from any cause through Day 90 post CPB
研究概览
简要总结
To assess the efficacy of ravulizumab in reducing risk of MAKE90 following CPB
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •≥ 18 to ≤ 90 years of age at the time of signing the informed consent.
- •Male or female; Female participants of childbearing potential and male participants must follow protocol-specified contraception guidance.
- •Body weight ≥ 30 kg at Screening.
- •Planned non-emergent cardiac surgery requiring CPB for the following procedures: 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 or apparent CKD (by history, diagnostic results, or reasonable medical assessment made by the Investigator and recorded in the medical record) and eGFR ≥ 20 to < 60 mL/min/1.73 m2 using CKD-EPI equation by sCr or sCysC measurement, obtained by local or central laboratory during the 28 days prior to randomization
- •At risk for postsurgical kidney events as defined by a minimum STS Calculator Renal Failure Risk Score of ≥ 2.8% 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 (ICF) and in this protocol.
排除标准
- •Emergency or salvage cardiac surgery is expected at screening or randomization, as assessed by the Investigator
- •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 investigational product (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 < 3 months.
- •Single-vessel CABG without valve surgery is planned.
- •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, if needed
- •Off-pump surgery is planned (eg, surgery without CPB).
- •Any use of KRT or presence of AKI within 30 days prior to randomization (AKI defined as 1.5x increase in sCr over baseline), except transient (≤ 5 days) Stage 1 AKI after iodinated contrast exposure. Presence of AKI must be assessed within 72 hours prior to randomization.
- •Recipient of a solid organ or bone marrow transplantation.
- •Cardiogenic shock or hemodynamic instability, including use of intra-aortic balloon pump (IABP) or other temporary cardiac output support device, extracorporeal membrane oxygenation (ECMO), or left ventricular assist device within 72 hours prior to randomization.
- •Active systemic bacterial, viral, or fungal infection within 14 days prior to randomization.
- •History of unexplained, recurrent infection.
- •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 prior to Screening.
- •Congenital immunodeficiency.
- •Use of IVIg (eg, as acute therapy) within 4 weeks prior to dosing.
- •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.
- •History of, or unresolved, N meningitidis infection
- •Hypersensitivity to any ingredient contained in the study intervention, including hypersensitivity to murine proteins.
- •Current malignancy (excluding local or regional prostate cancer or non-melanoma skin cancer, or indolent disease not being treated) or receiving treatment for malignancy
- •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 any pharmacologic agent specifically for prevention or treatment of AKI.
- •Anticipated use of KRT, extracorporeal membrane oxygenation, or temporary cardiac support devices including left ventricular assist device between randomization and surgery. Elective or pre-emptive insertion of temporary cardiac support devices (including IABP) in the absence of cardiogenic shock or hemodynamic instability.
结局指标
主要结局
MAKE90 defined as meeting at least 1 of the following criteria: o Decrease from baseline in eGFR (CKD-EPI formula using sCysC) of ≥ 25% at Day 90 post CPB, or o Initiation of KRT through Day 90 post CPB, or o Death from any cause through Day 90 post CPB
MAKE90 defined as meeting at least 1 of the following criteria: o Decrease from baseline in eGFR (CKD-EPI formula using sCysC) of ≥ 25% at Day 90 post CPB, or o Initiation of KRT through Day 90 post CPB, or o Death from any cause through Day 90 post CPB
次要结局
- 1) Occurrence of CSA-AKI without recovery at Day 90 post CPB
- 2) Occurrence of severe CSA-AKI (KDIGO Stage 2 or 3) from randomization to Day 7 post CPB
- 3) Occurrence of severe AKI (KDIGO Stage 2 or 3) from randomization to Day 30 post CPB
- 6) Length of post-operative ICU stay
- 4) Occurrence of KRT or death from randomization to Day 90 post CPB
- 5) All-cause mortality from randomization to Day 90 post CPB
- MAKE and its components at Days 30, 60 and 90 post CPB (excluding MAKE90 based on sCysC)
- Occurrence of KRT or death by Days 30 and 60 Post CPB
- Highest CSA-AKI stage within 3 and 7 days post CPB
- Occurrence of CSA-AKI without recovery at Day 15, 30 and 60 post CPB
- Occurrence of AKI at Days 3, 7, 15, 30, 60, and 90 post CPB
- AKI Progression on Days 15, 30, 60, and 90 post CPB for those experiencing CSA-AKI within 7 days post CPB: • Complete recovery • Partial recovery • Improvement • Stable • Worsening
- • Length of post-operative hospital stay • Number of days on ventilator through Day 30 and Day 90 post CPB; • Hospital readmission rate (all-cause or AKI-related) through Day 30 and Day 90 post CPB; • Days on KRT through Day 30 and Day 90 post CPB
- Change from baseline in KDQOL-36™ at Days 30, 60, and 90 post CPB; Change from baseline in EQ-5D-5L at Days 30, 60, and 90 post CPB; Change from baseline in FACIT-Fatigue at Days 30, 60, and 90 post CPB
- Serum concentrations of ravulizumab; Absolute values, change from baseline and percent change from baseline in serum free C5 concentrations
- • TEAEs and TESAEs; • Change from baseline in laboratory parameters at scheduled visits
- ADA status, ADA response categories, and titer at Day 90 post CPB
- Occurrence of post-operative Renal Failure (STS metric based on RIFLE Failure creatinine criteria)
研究者
European Clinical Trial Information
Scientific
Alexion Pharmaceuticals Inc.
研究点 (47)
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