A Phase 2, Multicenter, Placebo-controlled, Double-blind, Randomized, Parallel-group Trial to Investigate the Efficacy and Safety of Orally Administered Tolvaptan (OPC-41061) in Patients With Chronic Renal Failure Undergoing Hemodialysis or Hemodiafiltration
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 124
- 主要终点
- Change From Baseline in Daily Urine Volume
研究概览
简要总结
This is a study to investigate the efficacy and safety of OPC-41061 by 24-week oral administration of OPC-41061 at 15-mg or 30-mg or placebo in patients with chronic renal failure who are undergoing hemodialysis or hemodiafiltration and who have daily urine volume of at least 500 mL/day.
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic renal failure requiring hemodialysis or hemodiafiltration 3 times a week
- •Daily urine volume of ≥ 500 mL/day
- •Male or female patients age 20 to 80 years, inclusive
- •Use of one of the specified contraceptive methods until 4 weeks after final IMP administration
- •Capable of providing their own written informed consent prior to any trial-related procedures being performed
排除标准
- •Patients with a complication of urinary impairment due to urinary tract stricture, urinary calculus, tumor in urinary tract, or other cause
- •Patients with NYHA class IV heart failure
- •Patients with impaired hepatic function(chronic hepatitis, drug-induced liver injury)
- •Patients with serious ischemic heart disease who are judged by the investigator or subinvestigator to be inappropriate for inclusion in the trial
- •Patients with serious arrhythmia who are judged by the investigator or subinvestigator to be inappropriate for inclusion in the trial
- •Patients with serious secondary hyperparathyroidism(intact parathyroid hormone > 500 pg/mL)
- •Patients who are concomitantly undergoing peritoneal dialysis
- •Patients with a history of cerebrovascular disease or coronary artery disease within 4 weeks prior to informed consent, a history of hypersensitivity to any ingredient of tolvaptan or benzazepine derivatives such as mozavaptan hydrochloride or a history of impaired hepatic function(chronic hepatitis, drug-induced liver injury)
- •Patients with any of the following abnormal laboratory values: hemoglobin < 8.0 g/dL, total bilirubin > 3.0 mg/dL, ALT (GPT) or AST (GOT) > 2 times the upper limit of the reference range, serum sodium > upper limit of the reference range, serum sodium < 125 mEq/L, or serum potassium > 6.0 mEq/L
- •Patients who are unable to sense thirst or who have difficulty with fluid intake
- •Patients who have received OPC-41061 in history.
- •Participation in any other clinical trial or post-marketing clinical study within 4 weeks prior to informed consent for the present trial
- •Female patients who are pregnant, possibly pregnant, or nursing
- •Patients otherwise judged by the investigator or subinvestigator to be inappropriate for inclusion in the trial
研究组 & 干预措施
OPC-41061 15mg/day
Will be orally administered once daily after breakfast on all days on which subjects do not undergo dialysis. OPC-41061 at 15 mg/day will be administered for 24 week.
干预措施: OPC-41061 (Drug)
OPC-41061 30mg/day
Will be orally administered once daily after breakfast on all days on which subjects do not undergo dialysis. OPC-41061 at 15 mg/day will be administered for 1 week and then OPC-41061 30 mg/day for 23 weeks
干预措施: OPC-41061 (Drug)
Placebo
Will be orally administered once daily after breakfast on all days on which subjects do not undergo dialysis. Placebo will be administered for 24 week.
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Daily Urine Volume
时间窗: Baseline，End of the treatment
Change in daily urine volume from baseline to the end of the treatment was calculated using descriptive statistics.
次要结局
- Change in Total Volume of Fluid Removed by Dialysis Per Week(Baseline，End of the treatment)