A Phase 2, Randomized, Double Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of CTP-499 in Type 2 Diabetic Nephropathy Patients Currently Treated With ACEI and/or ARB Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 170
- 试验地点
- 47
- 主要终点
- To assess the change in urinary albumin to creatinine ratio
研究概览
简要总结
This study is being conducted to evaluate the safety and efficacy of treatment with CTP-499 for 24 weeks in patients with chronic kidney disease, Type 2 diabetic nephropathy and who are currently receiving treatment with an angiotensin converting enzyme inhibitor (ACEI) and/or angiotensin II receptor blocker (ARB).
详细描述
There are two parts to this study, each part includes double-blind treatment with either CTP-499 or placebo. Part 1 will evaluate the safety and efficacy of treatment with CTP-499 twice daily for 24 weeks. Part 2 will evaluate the effects of longer term dosing for an additional 24 weeks. Following Part 2, patients will be allowed to participate in an Open Label extension with CTP-499 for a period of an additional 48 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female 18 years or older
- •Patient diagnosed with Type 2 diabetes mellitus and chronic kidney disease
- •On a stable regimen of ACE inhibitors and/or ARB drugs for a minimum of 4 weeks
- •Not expected to start dialysis for one year
- •Patient has blood pressure less than or equal to 145/90 mm Hg
- •Patient has UACR greater than or equal to 200 mg/g if male and 300 mg/g if female but not more than 5000 mg/g
- •Patient has glycosylated hemoglobin A1c less than or equal to 10.5%
排除标准
- •Patient has concurrent condition such as uncontrolled inflammatory disease, acute infection or other unstable illnesses
- •Patient has a history of allergy or sensitivity to pentoxifylline or methylxanthines
- •Patient has acute, active and/or unstable renal impairment or has been hospitalized for acute renal failure within the previous year
- •Patient has active malignancy or history of neoplastic disease
- •Patient has a QTc interval greater than 450 milliseconds
- •Patient has ALT or AST greater than 3 times the upper limit of normal or a potassium greater than or equal to 5.5mEq/L at screening
- •Patient is breast feeding or pregnant
研究组 & 干预措施
Placebo
matching placebo tablets
干预措施: Placebo (Drug)
CTP-499
600 mg tablet
干预措施: CTP-499 (Drug)
结局指标
主要结局
To assess the change in urinary albumin to creatinine ratio
时间窗: Weeks 16, 20, 24
次要结局
未报告次要终点