NCT04496596进行中（未招募）2 期
A Prospective, Double-Blind, Placebo-controlled Study of Suramin in Subjects With Furosemide-Resistant Acute Kidney Injury (AKI): Efficacy in Preventing Dialysis Dependent AKI
Rediscovery Life Sciences12 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2020年11月13日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 68
- 试验地点
- 12
- 主要终点
- To evaluate and compare the efficacy of a single 3.0 mg/kg infusion of suramin versus placebo in subjects with diuretic unresponsive AKI
研究概览
简要总结
This is a prospective, double-blind, randomized, placebo-controlled study to assess the effects of suramin as a potential treatment option to prevent subjects with AKI from progressing to Kidney Disease Improving Global Outcomes (KDIGO) Stage III or dialysis dependent AKI.
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
- Double (Participant, Investigator)
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
- •At least 18 years of age at the time of signing the informed consent
- •KDIGO Stage I AKI and a serum Cr increase ≥ 0.3 mg/dL within 48 hr or 1.5 to 1.9-times baseline (pre-FST) Cr levels within 48 hr (± 6 hr) prior to randomization OR KDIGO Stage II AKI and serum Cr increase 2.0 to 2.9-times baseline (pre-FST) Cr levels within 48 hr (± 6 hr) prior to randomization
- •Fails to achieve a 200 mL increase in urine output within 2 hr following a 1.0 mg/kg bolus of furosemide (i.e., positive FST)
- •If female of childbearing potential, must have a negative pregnancy test at Screening Is capable of providing informed consent as described in in this protocol.
排除标准
- •Receiving hemodialysis or peritoneal dialysis
- •Prior renal transplant (other organ transplants are not excluded)
- •Known baseline (pre-FST) estimated glomerular filtration rate (eGFR) ≤ 20 mL/min
- •Evidence of hydronephrosis or obstructive uropathy confirmed by renal ultrasound (for subjects without a documented ultrasound, the
- •Investigator will determine if a renal ultrasound is indicated, consistent with the standard of care (SOC)
- •Hepatic encephalopathy, Child class C cirrhosis, and/or clinical suspicion of hepatorenal syndrome
- •International normalized ratio (INR) ≤ 3.0, unless on stable long-term warfarin therapy within 2 weeks prior to randomization
- •Known human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection
- •Known coronavirus (COVID-19) infection
- •White blood cell count (WBC) < 2,000/μL and/or platelet count < 30,000/μL at the time of Screening
- •A sequential organ failure assessment (SOFA) score > 10 during Screening
- •Subjects requiring 3 or more vasopressor agents of any combination to maintain a mean arterial pressure > 65 mm Hg
- •Unwilling to participate in follow-up phone surveys up to 180 days post-treatment
- •Are enrolled in another interventional research study or have participated in another interventional study within 14 days of Screening.
研究组 & 干预措施
Suramin
Experimental
干预措施: Suramin (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
To evaluate and compare the efficacy of a single 3.0 mg/kg infusion of suramin versus placebo in subjects with diuretic unresponsive AKI
时间窗: 7 days
The difference between the effect of a 3.0 mg/kg infusion of suramin versus placebo will be based on meeting 2 or more of the composite event endpoints of: peak serum creatinine (Cr) of 6 mg/dL or above from investigational product (IP) infusion through Day or progression to KDIGO Stage III within 72 hours (hr) from IP infusion or death or dialysis from IP infusion through Day 7.
次要结局
未报告次要终点
研究者
研究点 (12)
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