A Phase II, Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Efficacy and Safety of CRMD-001 in Contrast-Induced Acute Oxidative Kidney Injury
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- CorMedix
- 入组人数
- 60
- 试验地点
- 8
- 主要终点
- Biomarker evidence of Acute Kidney injury
研究概览
简要总结
The primary objective of this trial is to assess the impact of CRMD-001 on markers of contrast-induced acute kidney injury (AKI) in high-risk patients with chronic kidney disease (CKD) undergoing coronary angiography and PCI.
详细描述
This trial will evaluate whether treatment with CRMD-001 (unique formulations of the iron chelator, Deferiprone) will reduce the incidence of AKI in subjects with CKD and additional risk factors. Adult subjects with moderate to severe CKD who are undergoing coronary angiography and PCI will be randomized to either placebo or CRMD-001 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 mean paired change of a panel of sensitive renal biomarkers between the groups. Differences in renal or cardiovascular clinical events will also be evaluated.
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 of < 60 ml/min/1.73 m2
- •Presence of at least one additional risk factor:
- •Diabetes Mellitus
- •Age ≥ 75 years
- •Left Ventricular Ejection Fraction ≤ 40%
排除标准
- •End-Stage Renal Disease
- •Recent change in serum creatinine
- •Primary PCI for STEMI
- •Currently receiving mechanical ventilation
- •Severe heart failure of cardiogenic shock
- •Requirement for inotropic support (prior 30 days)
- •Sustained hypertension > or = 200/110
- •Subject not expected to live for 90 days
- •Anticipated use of ioxaglate or iohexol
- •Currently receiving fenoldopam, dopamine, theophylline, aminophylline, mannitol, N-acetyl cysteine or Ascorbic acid
- •Absolute neutrophil count < 1500
- •Hemoglobin < 8 gm/dL
研究组 & 干预措施
CRMD-001-Deferiprone
干预措施: CRMD-001-Deferiprone (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Biomarker evidence of Acute Kidney injury
时间窗: 8 Days
Mean paired change in a panel of acute kidney injury (AKI) biomarkers (urinary NGAL, LFABP, interleukin-18 (IL-18), kidney injury molecule-1 (KIM-1), urinary alpha GST (proximal tubular injury), Pi GST (distal tubular injury) and cystatin C; serum cystatin C) from baseline (Day 1) to peak in the deferiprone and placebo treatment groups, within 192 hours of contrast exposure
次要结局
- Incidence of Acute Kidney Injury(48 hours)