2024-511621-64-00已完成2 期
A randomized, multi-centric, placebo-controlled, participant and investigator-blinded study to evaluate the safety, tolerability and efficacy of TIN816 in adult patients at risk for acute kidney injury following cardiac surgery
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 25
- 主要终点
- Ratio of the highest serum creatinine value (up to and including Study Day 6) versus baseline
研究概览
简要总结
To assess the effect of TIN816 on serum creatinine levels in patients at high risk for AKI and undergoing major cardio-vascular surgery, versus placebo
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
- •Signed informed consent must be obtained prior to participation in the study. Article I. Participants must be able to communicate well with the investigator and to understand and comply with the requirements of the study. Article II. Male and female patients ≥45 years at screening Article III. Participants must weigh at least 50 kg and maximum 150 kg to participate in the study and must have a body mass index (BMI) below
- •BMI = Body weight (kg) /[Height (m)]2
- •At screening, vital signs should be assessed in the sitting or supine position and be within the following ranges: a. body temperature between 35.0-37.5 °C b. blood pressure (systolic 100-160 mmHg, diastolic < 100 mmHg) c. pulse rate (50-100/min) stable with or without medication(s) as per Investigator‘s assessment. If vital signs are outside these ranges, the Investigator may obtain two additional readings, so that up to three consecutive assessments are made. At least the last reading must be within the ranges provided above for the participant to qualify.
- •Stable renal function with no known increase in SCr of ≥25% at screening visit compared to a previous value obtained within the last 6 months as documented by a local laboratory using standard assay methodology, and no AKI present (any stage) at pre-surgery baseline at discretion of the investigator.
- •Non-emergent open chest cavity major cardiopulmonary bypass (CPB) surgery with expected CPB time ≥1 hour
排除标准
- •eGFR at screening <15 mL/min/1.73 m2 (calculated using CKD-EPI 2021 equation)
- •Receiving renal replacement therapy (RRT) currently or at any time within 3 months prior to screening, or scheduled to start RRT shortly after cardiac surgery.
- •Patients with bleeding risk at screening, or identified as such pre-surgery if screening was performed earlier than Day -
- •The Investigator should make this determination in consideration of the participant's medical history and/or clinical or laboratory evidence of any of the following: • History of bleeding with suspected or confirmed bleeding disorder or any other high risk for bleeding in the opinion of the investigator • Thrombocytopenia: platelet count <100x109/L • History of platelet dysfunction e.g., ADP induced platelet aggregation lower than 60% • History of coagulation factor deficiencies, including but not limited to fibrinogen ≤ 2.5 g/L or Von Willebrand factor (vWF) ≤ 50 IU/dL.
- •Duration of cardiopulmonary bypass (CPB) <60 minutes
- •Patient with active bleeding at the end of the surgery as per assessment of the leading surgeon
- •Donation or loss of >450 mL of blood or > 200 mL of plasma within four weeks prior to dosing, or longer if required by local regulation
- •Scheduled to undergo cardiac surgery off CPB or with hypothermic circulatory arrest or scheduled to undergo TAVI or TAVR only or single vessel, minimally invasive direct coronary artery bypass (MIDCAB) off-pump surgeries or left ventricular assist device (LVAD) implantation.
结局指标
主要结局
Ratio of the highest serum creatinine value (up to and including Study Day 6) versus baseline
Ratio of the highest serum creatinine value (up to and including Study Day 6) versus baseline
次要结局
- Safety based on vital signs, physical examination, ECGs, laboratory assessments and collection of AEs assessed from baseline until the end of the study visit
- AKI stages 1, 2 and 3 as defined by modified AKI Network (AKIN) criteria for serum creatinine
- Anti-drug antibodies against TIN816
- Occurrence of major adverse kidney events at day 30 (MAKE30) and day 90 (MAKE90) Occurrence of individual components of the MAKE criteria at Days 30 or 90.
研究者
Novartis Pharma Arzneimittel GmbH
Scientific
Novartis Pharma AG
研究点 (25)
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