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

NCT ID: NCT02331680

Last Updated: 2019-10-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2016-05-31

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.

Conditions

Chronic Renal Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

OPC-41061 15mg/day

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.

Group Type: EXPERIMENTAL

OPC-41061

Intervention Type: DRUG

OPC-41061 30mg/day

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

Group Type: EXPERIMENTAL

OPC-41061

Intervention Type: DRUG

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

OPC-41061

Intervention Type: DRUG

OPC-41061

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Other Intervention Names

Tolvaptan; Tolvaptan; Blank Tablet

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Otsuka Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hiroaki Ono, Mr.

Role: STUDY_DIRECTOR

Otsuka Pharmaceutical Co., Ltd.

Locations

Kanto, Region, Japan

Kinki, Region, Japan

Kyushu, Region, Japan

Tōhoku, Region, Japan

Countries

Japan

Other Identifiers

JapicCTI-142756

Identifier Type: OTHER

Identifier Source: secondary_id

156-13-003

Identifier Type: -

Identifier Source: org_study_id