NCT01935167已完成2 期
A Phase Ⅱ, Prospective, 24 Weeks, Double-blind, Placebo-controlled, Randomized, Multi-center Clinical Trial for the Evaluation of the Efficacy and Safety of DW1029M on Microalbuminuria in Patients With Diabetic Nephropathy
Dong Wha Pharmaceutical Co. Ltd.1 个研究点 分布在 1 个国家目标入组 158 人开始时间: 2013年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 158
- 试验地点
- 1
- 主要终点
- log ACR
研究概览
简要总结
Phase 2 clinical study to evaluate of the efficacy and safety of DW1029M on microalbuminuria in Patients With Diabetic Nephropathy
详细描述
A Phase Ⅱ, prospective, 24 weeks, double-blind, placebo-controlled, randomized, multi-center clinical trial for the evaluation of the efficacy and safety of DW1029M on microalbuminuria in Patients With Diabetic Nephropathy
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
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has confirmed diabetic mellitus prior to 6years
- •Has confirmed microalbuminuria 30 ~ 299㎍/㎎creatinine prior to 5months one time and microalbuminuria 30 ~ 299㎍/㎎creatinine during screening period
- •Blood Pressure(BP) ≤ 150 / 90 mmHg
- •estimated glomerular filtration rate(eGFR) ≥ 30 ml/min/1.73m2
- •Hemoglobin A1c(HbA1c) ≤ 9%
- •Low density lipoprotein(LDL-C) ≤ 130mg/dl
排除标准
- •kidney or liver disease as follows i.Serum Creatinine > 2.0mg/dl ii.Alanine Aminotransferase(ALT) or Aspartate Aminotransferase(AST) > 2 x Upper Limit Normal(ULN) iii.Total Bilirubin > 2 x ULN
- •Organic gastrointestinal disorder or Chronic gastroenterologic disorders prior to 6 months as follows [NOTE] Active Crohn's disease, Active ulcerative colitis, Chronic peptic ulcer disease, etc.
- •cardiovascular disease prior to 3 months as follows [NOTE] Unstable angina pectoris, Myocardial infarction, Coronary artery bypass surgery, Percutaneous Transluminal Coronary Angioplasty, transient ischemic attack, cerebrovascular accident etc.
研究组 & 干预措施
A Group
Experimental
DW1029M 600mg for 24 weeks
干预措施: DW1029M 600mg (Drug)
B Group
Experimental
DW1029M 1200mg for 24 weeks
干预措施: DW1029M 1200mg (Drug)
C Group
Placebo Comparator
Placebo for 24 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
log ACR
时间窗: 24 weeks after 1st administration
logarithm of the Albumin Creatinine Ratio(ACR) after 24 weeks
次要结局
- eGFR(12 and 24 weeks after 1st administration)
- log ACR(12 weeks after 1st administration)
- SCC(12 and 24 weeks after 1st administration)
- Log UAE(24 weeks after 1st administration)
- Cystatin C(12 and 24 weeks after 1st administration)
研究者
研究点 (1)
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