Overview

This trial is active, not recruiting.

Condition chronic renal failure
Treatments opc-41061, placebo
Phase phase 2
Sponsor Otsuka Pharmaceutical Co., Ltd.
Start date December 2014
End date December 2016
Trial size 120 participants
Trial identifier NCT02331680, 156-13-003

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
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.
opc-41061 Tolvaptan
(Experimental)
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
opc-41061 Tolvaptan
(Placebo Comparator)
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.
placebo Blank Tablet

Primary Outcomes

Measure
Change from baseline in daily urine volume for 24weeks
time frame: Baseline, 2, 4, 8, 12, 16, 20, and 24weeks

Secondary Outcomes

Measure
Total fluid removal volume by dialysis per week
time frame: Baseline, 2, 4, 8, 12, 16, 20, and 24weeks

Eligibility Criteria

Male or female participants from 20 years up to 80 years old.

Inclusion Criteria: - 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 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 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

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Otsuka Pharmaceutical Co., Ltd..