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

October 2, 2019 updated by: Otsuka Pharmaceutical Co., Ltd.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

124

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Region
      • Kanto, Region, Japan
      • Kinki, Region, Japan
      • Kyushu, Region, Japan
      • Tohoku, Region, Japan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: OPC-41061
Other Names:
  • Tolvaptan
Experimental: 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
Drug: OPC-41061
Other Names:
  • Tolvaptan
Placebo Comparator: 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.
Drug: Placebo
Other Names:
  • Blank Tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Daily Urine Volume
Time Frame: Baseline，End of the treatment
Change in daily urine volume from baseline to the end of the treatment was calculated using descriptive statistics.
Baseline，End of the treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Total Volume of Fluid Removed by Dialysis Per Week
Time Frame: 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.
Baseline，End of the treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Otsuka Pharmaceutical Co., Ltd.

Investigators

  • Study Director: Hiroaki Ono, Mr., Otsuka Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

December 23, 2014

First Submitted That Met QC Criteria

January 5, 2015

First Posted (Estimate)

January 6, 2015

Study Record Updates

Last Update Posted (Actual)

October 22, 2019

Last Update Submitted That Met QC Criteria

October 2, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 156-13-003
  • JapicCTI-142756 (Other Identifier: Japic)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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