A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Deferiprone in the Reduction of Morbidity and Mortality in Patients With Chronic Kidney Disease Undergoing Diagnostic or Interventional Cardiac Procedures and Receiving an Iodinated Radiocontrast Agent
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- CorMedix
- 主要终点
- A composite of renal and cardiovascular clinical events occurring through Day 90
研究概览
简要总结
This trial will evaluate whether treatment with CRMD001 (unique formulations of the iron chelator, Deferiprone) will reduce morbidity and mortality in subjects with Chronic Kidney Disease (CKD) and additional risk factors. Adult subjects with moderate to severe CKD who are undergoing diagnostic or interventional coronary angiography will be randomized to either placebo or CRMD001 and followed for 90 days. Subjects will receive 8 days of randomized therapy starting 1-3 hours prior to angiography. The primary endpoint of the trial will be the difference in a composite of specified renal and cardiovascular clinical events occurring through Day 90.
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
- 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
- •Age 18 or older
- •eGFR between 15 ml/min/1.73 m2 and < 60 ml/min/1.73 m2
- •Presence of at least one additional risk factor:
- •Diabetes Mellitus type 1 or 2
- •Age ≥ 75 years
- •Left Ventricular Ejection Fraction ≤ 40%
排除标准
- •End-Stage Renal Disease
- •Primary PCI for STEMI
- •Currently receiving mechanical ventilation
- •Known active liver disease or liver failure
- •Evidence of hemodynamic instability, such as a requirement for pressor agents
- •Exposure to contrast media within prior 10 days
- •Currently receiving fenoldopam, dopamine, theophylline, aminophylline, mannitol, or Ascorbic acid (> 2 g/day)
- •Absolute neutrophil count < 1500
研究组 & 干预措施
CRMD001-Deferiprone
CRMD001 represents unique formulations of Deferiprone. Subjects will be given one (900 mg) immediate release and two (900 mg) extended release tablets 1-3 hours prior to angiography and then every 12 hours for a total of 8 days
干预措施: deferiprone (Drug)
Placebo
3 placebo tablets matching the appearance of the experimental treatment arm (CRMD001) will be given every 12 hours for a total of 8 days, beginning 1-3 hours prior to angiography
干预措施: Placebo (Drug)
结局指标
主要结局
A composite of renal and cardiovascular clinical events occurring through Day 90
时间窗: Day 90 following index cardiac catheterization
次要结局
未报告次要终点