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

Primary Purpose

Chronic Renal Failure

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
OPC-41061
OPC-41061
Placebo
Sponsored by
Otsuka Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Renal Failure focused on measuring Undergoing Hemodialysis, Undergoing Hemodiafiltration

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

OPC-41061 15mg/day

OPC-41061 30mg/day

Placebo

Arm Description

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.

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
December 23, 2014
Last Updated
October 2, 2019
Sponsor
Otsuka Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02331680
Brief Title
A Trial to Investigate the Efficacy and Safety of Orally Administered Tolvaptan (OPC-41061) in Patients With Chronic Renal Failure Undergoing Hemodialysis or Hemodiafiltration
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Otsuka Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Renal Failure
Keywords
Undergoing Hemodialysis, Undergoing Hemodiafiltration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
124 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OPC-41061 15mg/day
Arm Type
Experimental
Arm Description
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.
Arm Title
OPC-41061 30mg/day
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
OPC-41061
Other Intervention Name(s)
Tolvaptan
Intervention Type
Drug
Intervention Name(s)
OPC-41061
Other Intervention Name(s)
Tolvaptan
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Blank Tablet
Primary Outcome Measure Information:
Title
Change From Baseline in Daily Urine Volume
Description
Change in daily urine volume from baseline to the end of the treatment was calculated using descriptive statistics.
Time Frame
Baseline，End of the treatment
Secondary Outcome Measure Information:
Title
Change in Total Volume of Fluid Removed by Dialysis Per Week
Description
Change in total volume of fluid removed by dialysis per week from baseline to the end of the treatment was calculated using descriptive statistics.
Time Frame
Baseline，End of the treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hiroaki Ono, Mr.
Organizational Affiliation
Otsuka Pharmaceutical Co., Ltd.
Official's Role
Study Director
Facility Information:
City
Kanto
State/Province
Region
Country
Japan
City
Kinki
State/Province
Region
Country
Japan
City
Kyushu
State/Province
Region
Country
Japan
City
Tohoku
State/Province
Region
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

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

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