NCT01460199已完成1 期
A Multi Center, Double-Blind, Two-Arm,Placebo Controlled, Randomized Safety and Tolerability Study of CTP-499 in Non-Dialysis Patients With Stage 3 Chronic Kidney Disease
Concert Pharmaceuticals3 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2011年8月最近更新:
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
- 入组人数
- 33
- 试验地点
- 3
- 主要终点
- Safety measures
研究概览
简要总结
This study is being conducted to evaluate the safety and tolerability of treatment with CTP-499 in non-dialysis patients associated with moderate chronic kidney disease.
详细描述
This study will evaluate the safety and tolerability of treatment with CTP-499 starting with 600 milligrams (mg) once a day (QD) for 2 weeks followed by 600 mg twice a day (BID) for 2 weeks in non-dialysis patients associated with moderate chronic kidney disease defined as an estimated Glomerular Filtration Rate or eGFR that is 30-59 mL/min/1.73m2
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
- Triple (Participant, Care Provider, 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
- •Patient has a diagnosis of chronic kidney disease
- •If taking antihypertensive and antidiabetes medications, regimen must be stable for a minimum of 4 weeks
- •Patient has systolic blood pressure less than or equal to 160 mm Hg and diastolic blood pressure less than or equal to 95 mm Hg
排除标准
- •Patient has concurrent condition such as uncontrolled inflammatory disease, acute infection or clinically unstable autoimmune, endocrine, neurological, psychiatric, retinal, cardiovascular, bronchopulmonary, hepatic, gastrointestinal or musculoskeletal disorder
- •Patient has acute, active and/or current unstable renal impairment disease
- •Patient has been hospitalized for acute renal failure in the past year
- •Patient has active malignancy or a history of neoplastic disease
- •Patient has QTc interval > 450 milliseconds
- •Patient is currently on cytotoxic or other immunosuppressive therapy
研究组 & 干预措施
Placebo
Placebo Comparator
Matching Placebo
干预措施: placebo (Drug)
CTP-499
Experimental
干预措施: CTP-499 (Drug)
结局指标
主要结局
Safety measures
时间窗: 4 weeks
number of adverse events, vital signs, ECGs, clinical laboratory measures and physical exams
次要结局
- Pharmacokinetic Profile(4 weeks)
研究者
研究点 (3)
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