A Trial to Investigate the Efficacy and Safety of Orally Administered Tolvaptan (OPC-41061) in Patients With Chronic Renal Failure Undergoing Hemodialysis or Hemodiafiltration

Phase 2

Completed

• Conditions: Chronic Renal Failure
• Interventions: Drug: OPC-41061; Drug: Placebo

• Registration Number: NCT02331680
• Lead Sponsor: Otsuka Pharmaceutical Co., Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2014-12-23
• Study First Submitted QC: 2015-01-05
• Study First Posted: 2015-01-06
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Results First Submitted: 2018-02-13
• Status Verified: 2019-10
• Results First Submitted QC: 2019-10-02
• Last Update Submitted: 2019-10-02
• Results First Posted: 2019-10-22
• Last Update Posted: 2019-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OPC-41061 30mg/day	OPC-41061	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 15mg/day	OPC-41061	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.
Placebo	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.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Daily Urine Volume	Baseline，End of the treatment	Change in daily urine volume from baseline to the end of the treatment was calculated using descriptive statistics.

Secondary Outcome Measures

Name	Time	Method
Change in Total Volume of Fluid Removed by Dialysis Per Week	Baseline，End of the treatment	Change in total volume of fluid removed by dialysis per week from baseline to the end of the treatment was calculated using descriptive statistics.