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Open-label Dose-finding Trial of OPC-41061 in Patients With Chronic Renal Failure Undergoing Peritoneal Dialysis

Primary Purpose

Chronic Renal Failure

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
OPC-41061
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 Tolvaptan, dialysis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients diagnosed with chronic renal failure
  • Patients who are undergoing peritoneal dialysis (continuous ambulatory peritoneal dialysis [CAPD])

  • Patients who, after undergoing peritoneal dialysis, received any of the following medical treatments for fluid overload [OR: hypervolemia] that had insufficient effect:

    • Addition or increase of diuretics
    • Increase in concentration or volume of peritoneal dialysis fluid
    • Increase in the number of changes of peritoneal dialysis fluid
  • Subjects who, together with their partner, are able to practice one of the specified contraceptive methods until 4 weeks after the final trial drug administration
  • Subjects who are inpatients or who can be admitted to the trial site for the duration of the trial period

Exclusion Criteria:

  • Subjects with any of the following diseases, complications, or symptoms:

    • Suspected hypovolemia
    • Daily urine volume less than 200 mL
    • Urination impaired due to urinary tract stricture, urinary calculus, tumor in urinary tract, or other cause
    • Cardiac function of NYHA class 4

  • Subjects with any of the following medical histories:

    • History of cerebrovascular disorder or coronary artery disease within 4 weeks prior to informed consent
    • History of hypersensitivity or idiosyncratic reaction to benzazepine derivatives such as mozavaptan hydrochloride or benazepril hydrochloride
  • Subjects with any of the following abnormal laboratory values:

Hemoglobin lower than 9.0 g/dL, total bilirubin higher than 3.0 g/dL, ALT (GPT) or AST (GOT) 2 times the upper limit of the reference range of the trial site, serum sodium higher than the upper limit of the reference range of the trial site, serum sodium lower than 125 mEq/L, or serum potassium higher than 5.5 mEq/L

  • Subjects with any of the following conditions, concomitant diseases, or symptoms:

    • defect in diaphragm
    • hemorrhagic diathesis due to uremia
    • suspected lactic acid metabolic disorder
    • suspected peritonitis, peritoneal damage, peritoneal adhesion, or disorders in intraabdominal organs
  • Subjects who have undergone peritoneal dialysis for 8 years or longer
  • Subjects who are scheduled to undergo hemodialysis or concomitant use of hemodialysis, or renal transplantation
  • Subjects who have participated in any other clinical trial or post-marketing clinical studies within 30 days prior to informed consent
  • Subjects who have previously received OPC-41061
  • Subjects who are unable to sense thirst or who have difficulty with fluid or food intake
  • Female subjects who are pregnant, possibly pregnant, or nursing, or who plan to become pregnant during the trial period
  • Subjects otherwise judged by the investigator or subinvestigator to be inappropriate for inclusion in the trial

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

OPC-41061

Arm Description

Outcomes

Primary Outcome Measures

Change in Daily Urine Volume From Baseline
Change in daily urine volume from baseline during the repeated-administration period (For five days).
Percent Change in Daily Urine Volume From Baseline
Percent change in daily urine volume from baseline during the repeated-administration period (For five days).

Secondary Outcome Measures

Change in Body Weight From Baseline
Change in body weight from baseline during the repeated-administration period(For five days).
Percent Change in Body Weight
Percent change in body weight from baseline during the repeated-administration period(For five days).

Full Information

First Posted
July 4, 2013
Last Updated
November 30, 2015
Sponsor
Otsuka Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01895322
Brief Title
Open-label Dose-finding Trial of OPC-41061 in Patients With Chronic Renal Failure Undergoing Peritoneal Dialysis
Official Title
A Phase 2, Multi-center, Open-label, Dose-finding Trial to Investigate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of OPC-41061 in Patients With Chronic Renal Failure Undergoing Peritoneal Dialysis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
August 2014 (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
To investigate the efficacy, pharmacokinetics, pharmacodynamics, and safety of OPC-41061 in patients with chronic renal failure who are undergoing peritoneal dialysis, using daily urine volume, body weight, and edematous conditions as parameters and conducting dose escalation every 2 days until reaching the dose that achieves urine volume increase and then performing 5-day repeated administration at the fixed dose, the final dose used in the dose escalation period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Renal Failure
Keywords
Tolvaptan, dialysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OPC-41061
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
OPC-41061
Primary Outcome Measure Information:
Title
Change in Daily Urine Volume From Baseline
Description
Change in daily urine volume from baseline during the repeated-administration period (For five days).
Time Frame
Urine Volume on day13 minus Urine Volume at baseline(day9) on the repeated-administration period.
Title
Percent Change in Daily Urine Volume From Baseline
Description
Percent change in daily urine volume from baseline during the repeated-administration period (For five days).
Time Frame
100%*<Urine Volume on day13 minus Urine Volume at baseline(day9) on the repeated-administration period/Urine Volume at baseline(day9) on the repeated-administration period>
Secondary Outcome Measure Information:
Title
Change in Body Weight From Baseline
Description
Change in body weight from baseline during the repeated-administration period(For five days).
Time Frame
Body weight on day13 minus Body weight at baseline(day9) on the repeated-administration period
Title
Percent Change in Body Weight
Description
Percent change in body weight from baseline during the repeated-administration period(For five days).
Time Frame
100%*<Body weight on day13 minus Body weight at baseline (day9)/Body weight at baseline(day9)>

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients diagnosed with chronic renal failure Patients who are undergoing peritoneal dialysis (continuous ambulatory peritoneal dialysis [CAPD]) Patients who, after undergoing peritoneal dialysis, received any of the following medical treatments for fluid overload [OR: hypervolemia] that had insufficient effect: Addition or increase of diuretics Increase in concentration or volume of peritoneal dialysis fluid Increase in the number of changes of peritoneal dialysis fluid Subjects who, together with their partner, are able to practice one of the specified contraceptive methods until 4 weeks after the final trial drug administration Subjects who are inpatients or who can be admitted to the trial site for the duration of the trial period Exclusion Criteria: Subjects with any of the following diseases, complications, or symptoms: Suspected hypovolemia Daily urine volume less than 200 mL Urination impaired due to urinary tract stricture, urinary calculus, tumor in urinary tract, or other cause Cardiac function of NYHA class 4 Subjects with any of the following medical histories: History of cerebrovascular disorder or coronary artery disease within 4 weeks prior to informed consent History of hypersensitivity or idiosyncratic reaction to benzazepine derivatives such as mozavaptan hydrochloride or benazepril hydrochloride Subjects with any of the following abnormal laboratory values: Hemoglobin lower than 9.0 g/dL, total bilirubin higher than 3.0 g/dL, ALT (GPT) or AST (GOT) 2 times the upper limit of the reference range of the trial site, serum sodium higher than the upper limit of the reference range of the trial site, serum sodium lower than 125 mEq/L, or serum potassium higher than 5.5 mEq/L Subjects with any of the following conditions, concomitant diseases, or symptoms: defect in diaphragm hemorrhagic diathesis due to uremia suspected lactic acid metabolic disorder suspected peritonitis, peritoneal damage, peritoneal adhesion, or disorders in intraabdominal organs Subjects who have undergone peritoneal dialysis for 8 years or longer Subjects who are scheduled to undergo hemodialysis or concomitant use of hemodialysis, or renal transplantation Subjects who have participated in any other clinical trial or post-marketing clinical studies within 30 days prior to informed consent Subjects who have previously received OPC-41061 Subjects who are unable to sense thirst or who have difficulty with fluid or food intake Female subjects who are pregnant, possibly pregnant, or nursing, or who plan to become pregnant during the trial period Subjects 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
Kyoji Imaoka, Mr
Organizational Affiliation
Otsuka Pharmaceutical Co., Ltd.
Official's Role
Study Director
Facility Information:
City
Chubu Region
Country
Japan
City
Hokkaido Region
Country
Japan
City
Kanto Region
Country
Japan
City
Kyushu Region
Country
Japan
City
Shikoku Region
Country
Japan
City
Tohoku Region
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

Open-label Dose-finding Trial of OPC-41061 in Patients With Chronic Renal Failure Undergoing Peritoneal Dialysis

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