Double-Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Ilofotase Alfa in Patients at Risk for Renal Damage Following Open Heart Surgery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 271
- 试验地点
- 1
- 主要终点
- Assessment of serum creatinine values
研究概览
简要总结
The aim of this clinical trial is to evaluate the efficacy and safety of two intravenous administrations of ilofotase alfa in patients at risk for renal damage following open heart surgery.
详细描述
This is a Phase 2, multi-center, randomized, double-blind, placebo-controlled, 2-arm parallel group design trial in patients at risk for renal damage following open heart surgery. After screening and baseline assessments, eligible patients will be randomized 1:1 to either 2 doses of 128 mg ilofotase alfa, or 2 doses of placebo control. Randomization will be stratified by baseline eGFR and type of surgery. The patient will be treated with the investigational product (ilofotase alfa or placebo) at the same day before and after the surgery (Day 1). Follow-up clinic visits will be performed daily up to Day 5 for efficacy, safety, and pharmocokinetics assessments. A safety follow-up can be performed by telephone at Day 28. At Day 61, an end of trial visit will be done at site for efficacy, safety, and anti-drug antibodies assessments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Planned for one of the following types of open chest cardiovascular surgery with the use of cardiopulmonary bypass pump (CPB):
- •1. combined valve and CABG surgery;
- •aortic valve plus aortic root and/or ascending aorta (excluding aortic arch)
- •CABG with 3 or more distal anastomoses
- •Screening eGFR ≥25 mL/min/1.73m2 and ≤65 mL/min/1.73m2
- •Female patients of childbearing potential agreeing to use effective contraception within IP treatment and 14 days thereafter
- •Post-menopausal females do not require contraception during the trial.
- •Male patients agreeing to refrain from donating sperm, use a male condom when having sexual intercourse and in case their partner is of childbearing potential they must agree to use adequate and effective contraception method (see inclusion criterion 4) within IP treatment and 14 days thereafter
- •The five most important
排除标准
- •Body weight ≤55 kg
- •Known or suspected glomerulonephritis (other than diabetic kidney disease) or other systemic vasculitis
- •Confirmed or treated endocarditis requiring antimicrobial or antiviral treatment within 30 days prior to surgery or other current active infection requiring antimicrobial or antiviral treatment within 14 days prior to surgery
- •Known chronic liver disorder with Child-Pugh C classification
- •Current planned (or scheduled) surgical intervention under conditions of circulatory arrest, including planned deep hypothermic circulatory arrest
研究组 & 干预措施
Ilofotase alfa
干预措施: Ilofotase alfa (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Assessment of serum creatinine values
时间窗: From Baseline to Day 5
Ratio between the highest value postsurgery (post-surgery Day 1 and Days 2, 3, 4, and 5) and the pre-surgery baseline value for serum creatinine
次要结局
- Assessment of major adverse kidney events (MAKE) 60(Daily post-surgery through Day 5)
- Assessment of adverse event (AE) and serious adverse event (SAE) occurrence(From Day -1 to Day 28)