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 Hemodiafiltratio
- Conditions
- Patients with chronic renal failure who were undergoing hemodialysis or hemodiafiltration and who had daily urine volume of at least 500 m
- Registration Number
- JPRN-jRCT2080222704
- Lead Sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 120
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
- 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Daily urine volume<br>Change and percent change from baseline
- Secondary Outcome Measures
Name Time Method Total fluid removal volume by dialysis per week<br>Change and percent change from baseline