NCT01485900已完成1 期
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability and Hemodynamics of Ascending Repeated Oral Doses of SAR407899A in Patients With Moderate Chronic Kidney Disease on Stable Angiotensin Converting Enzyme-inhibitor (ACE-I) Treatment
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Number of patients reporting Adverse Events (AEs)
研究概览
简要总结
Primary Objective:
- To assess the tolerability and safety of repeated oral ascending doses of SAR407899A in patients with moderate chronic kidney disease (CKD) on stable angiotensin converting enzyme-inhibitor (ACE-I)
Secondary Objectives:
- To assess in patients with moderate CKD the effect of concomitant multiple dose of SAR407899A and ACE-Is on office and 24-hr ambulatory blood pressure and heart rate
- The effect of repeated multiple doses of SAR407899A on the pharmacodynamic response to ACE-Is (AcSDKP)
- The pharmacokinetic profile of repeated oral administration of SAR407899A during co-administration of ACE-Is
详细描述
The total duration for this study will be around 8 weeks.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Cohort 1
Experimental
Dose 1: 20 days 3-step uptitration with doses A, B, and C of SAR407899 vs. placebo
干预措施: SAR407899A (Drug)
Cohort 2
Experimental
Dose 2: 20 days 3-step uptitration with doses B, C and D of SAR407899 vs. placebo
干预措施: SAR407899A (Drug)
结局指标
主要结局
Number of patients reporting Adverse Events (AEs)
时间窗: 8 weeks
次要结局
- Clinical safety laboratory measurement including hematology and biochemistry(8 weeks)
- urine and blood renal function markers(8 weeks)
- ECG, vital signs measurements (Heart rate and systolic and diastolic blood pressure)(8 weeks)
- AcSDKP (tetrapeptide of the composition N-Acetyl-Ser-Asp-Lys-Pro)(8 weeks)
- AUC(8 weeks)
- Cmax(8 weeks)
- t1/2z(8 weeks)
- 24-hr ambulatory blood pressure(Day-1, Day 14 and Day 19)
研究者
研究点 (2)
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