Patients with chronic renal failure who were undergoing hemodialysis or hemodiafiltration and who had daily urine volume of at least 500 mL
Conditions
Interventions
investigational material(s)
Generic name etc : OPC-41061
INN of investigational material : Tolvaptan
Therapeutic category code : 213 Diuretics
Dosage and Administration for Investigational material :
Sponsors
Otsuka Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Daily urine volume Change and percent change from baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Total fluid removal volume by dialysis per week Change and percent change from baseline | — |
Outcome results
None listed