NIPH Clinical Trials Search

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	Patients with chronic renal failure who were undergoing hemodialysis or hemodiafiltration and who had daily urine volume of at least 500 mL
Date of first enrollment	24/12/2014
Target sample size	120
Countries of recruitment
Study type	Interventional
Intervention(s)	investigational material(s) Generic name etc : OPC-41061 INN of investigational material : Tolvaptan Therapeutic category code : 213 Diuretics Dosage and Administration for Investigational material : Will be orally administered once daily after breakfast on all days on which subjects do 0not undergo dialysis. (15mg arm) OPC-41061 at 15 mg/day will be administered for 24 weeks. (30mg arm) OPC-41061 at 15 mg/day will be administered for 1 week and then OPC-41061 30 mg/day for 23 weeks. control material(s) Generic name etc : Placebo INN of investigational material : Therapeutic category code : --- Other Dosage and Administration for Investigational material : Will be orally administered once daily after breakfast on all days on which subjects do not undergo dialysis. Placebo will be administered for 24 weeks.

Outcome(s)

Primary Outcome	Daily urine volume Change and percent change from baseline
Secondary Outcome	Total fluid removal volume by dialysis per week Change and percent change from baseline

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	<= 80age old
Gender	Both
Include criteria	- Chronic renal failure requiring hemodialysis or hemodiafiltration 3 times a week - Daily urine volume of : 500 mL/day and more - 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
Exclude criteria	- 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 4 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 higher than 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 lower than 8.0 g/dL, total bilirubin higher than 3.0 mg/dL, ALT (GPT) or AST (GOT) twice the upper limit of the reference range, serum sodium higher than upper limit of the reference range, serum sodium lower than 125 mEq/L, or serum potassium higher than 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