A Multicenter, Prospective, Parallel-Group, Double-Blind, Randomized, Placebo-Controlled, Phase 2 Study of ANG-3777 to Assess the Safety and Efficacy of BB3 in Patients Developing Acute Kidney Injury After Cardiac Surgery
试验速览
- 阶段
- 2 期
- 入组人数
- 275
- 试验地点
- 40
- 主要终点
- The mean AUC of the percent increase in serum creatinine above baseline
研究概览
简要总结
The objective of the study is to assess the safety and efficacy of ANG-3777 in preventing AKI compared to placebo when administered to patients at risk for developing acute kidney injury (AKI) following cardiac surgical procedures involving cardiopulmonary bypass (CPB).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, 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
- •Patient is either male or female ≥ 18 years.
- •Patient has provided written informed consent, and is willing and able to comply with the requirements of the study protocol, including screening procedures.
- •Patient must be scheduled for and undergo a non-emergent cardiac surgical procedure involving CPB. Eligible procedures include:
- •Coronary artery bypass graft (CABG) alone
- •Aortic valve replacement or repair alone, with or without aortic root repair
- •Mitral, tricuspid, or pulmonic valve replacement or repair alone
- •Combined replacement of several cardiac valves
- •CABG with aortic, mitral, tricuspid, or pulmonic valve replacement or repair
- •CABG with combined cardiac valve replacement or repair.
- •Patient must have the following risk factor(s) for AKI prior to surgery:
- •Estimated glomerular filtration rate (eGFR) of ≥ 20 and < 30 ml/min/1.73m2, or
- •eGFR ≥ 30 and < 60 mL/min/1.73m2 and ONE of the following Additional Risk Factors (other than age ≥ 75 years), or
- •eGFR ≥ 60 ml/min/1.73m2 and TWO of the following Additional Risk Factors
- •eGFR will be calculated using the abbreviated MDRD equation (MDRD-4, often referred to as the Levey equation): eGFR = 186.3 x sCr-1.154 x Age-0.203 x [0.742 if Female] x [1.212 if Black]
- •Additional Risk Factors:
- •Combined valve and coronary surgery
- •Previous cardiac surgery with sternotomy
- •Left ventricular ejection fraction (LVEF) < 35% by invasive or noninvasive diagnostic cardiac imaging within 90 days prior to surgery
- •Diabetes mellitus requiring insulin treatment
- •Non-insulin-requiring diabetes with documented presence of at least moderate (+2 or > 100 mg/dL) proteinuria on urine analysis (medical history or dipstick)
- •Documented NYHA Class III or IV within 1 year prior to index surgery
- •Age ≥ 75 years can be considered an Additional Risk Factor only for patients with eGFR ≥ 60 ml/min/1.73m
- •Patient must have presented for surgery without prior evidence of active renal injury defined as no acute rise in sCr > 0.3 mg/dL or no 50% increase in sCr between the time of Screening and pre-surgery.
- •Patient's body mass index (BMI) < 40 at Screening.
排除标准
- •Patient has eGFR < 20 mL/min/1.73 m2 within 48 hours pre-surgery as measured by MDRD
- •Patient has ongoing sepsis or partially treated infection. Sepsis is defined as the presence of a confirmed pathogen, along with fever or hypoperfusion (i.e., acidosis and new onset elevation of liver function tests) or hypotension requiring pressor use prior to surgery.
- •Currently active infection requiring antibiotic treatment.
- •Patient who has an active (requiring treatment) malignancy or history within 5 years prior to enrollment in the study, of solid, metastatic or hematologic malignancy with the exception of basal or squamous cell carcinoma of the skin that has been removed.
- •Administration of iodinated contrast material within 24 hours prior to cardiac surgery.
- •Patients diagnosed with AKI as defined by KDIGO criteria within 48 hours prior to surgery.
研究组 & 干预措施
ANG-3777
Study drug will be administered for a total of 4 daily intravenous (IV) infusions. The first post-operative dose MUST be started within 4 hours of completing CPB. The second dose will be administered 24 ± 2 hours after completing CPB, and the third and fourth doses will be administered 24 ± 2 hours after each previous dose. Duration of administration is 30 minutes.
干预措施: ANG-3777 (Drug)
Normal Saline
The placebo will be administered for a total of 4 daily intravenous (IV) infusions. The first post-operative dose MUST be started within 4 hours of completing CPB. The second dose will be administered 24 ± 2 hours after completing CPB, and the third and fourth doses will be administered 24 ± 2 hours after each previous dose. Duration of administration is 30 minutes.
干预措施: Placebo (Drug)
结局指标
主要结局
The mean AUC of the percent increase in serum creatinine above baseline
时间窗: starting from 24 hr after the end of CPB through Day 6
次要结局
未报告次要终点