NCT01847092已完成2 期
An Exploratory Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel Design Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of AZD1722 in CKD Patients With Type 2 Diabetes Mellitus and Albuminuria
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
- Ardelyx
- 入组人数
- 154
- 试验地点
- 1
- 主要终点
- Changes in Urine Albumin to Creatinine Ratio (UACR)
研究概览
简要总结
The purpose of this study is to determine if the study drug is safe, tolerable and active in reducing albuminuria in patients with Chronic Kidney Disease with Type 2 Diabetes.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females aged 18 to 80 years, inclusive.
- •Body mass index between 18 and 45 kg/m2, inclusive.
- •Type 2 diabetes mellitus and receiving ≥1 glucose lowering medication for at least 3 months prior to randomization
- •Stage 3 CKD
- •MSSBP ≥130 mmHg
- •Urinary albumin: mean UACR ≥ 200 mg/g
排除标准
- •Urinary albumin: UACR > 3500 mg/g
- •History of a renal transplant
- •MSSBP >180 mmHg or a MSDBP of >120 mmHg on two occasions during screening or run-in periods
- •History of inflammatory bowel disease or diarrhea predominant irritable bowel syndrome
研究组 & 干预措施
AZD1722
Active Comparator
AZD1722 in 5, 15, 30, or 60 mg capsules. Starting dose is 15 mg BID PO for 12 Weeks
干预措施: AZD1722 (Drug)
Placebo
Placebo Comparator
Placebo capsule BID PO for 12 Weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Changes in Urine Albumin to Creatinine Ratio (UACR)
时间窗: Week 12
The difference between tenapanor and placebo in the change in UACR from baseline to the end of 12 weeks of treatment
次要结局
- Change in Estimated Glomerular Filtration Rate (mL/Min/1.73 m2) From Baseline to Week 12 Endpoint(12 weeks)
研究者
研究点 (1)
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