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 Hemodialysis or Hemodiafiltration
Primary Purpose
Chronic Renal Failure
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
OPC-41061
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Renal Failure
Eligibility Criteria
Inclusion Criteria:
- Patients with chronic renal failure who are undergoing hemodialysis or hemodiafiltration three times a week
- Subjects between the ages of 20 and 80, inclusive (at time of informed consent)
- Subjects who are inpatients or who can be admitted to the trial site for the duration of the trial period
- 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
- Patients who are capable of providing written informed consent themselves before any trial-related procedures are performed
Exclusion Criteria:
- Subjects with a complication of urinary impairment due to urinary tract stricture, urinary calculus, tumor in urinary tract, or other cause
- Subject with daily urine volume less than 500 mL
- Subject with Cardiac function of NYHA class 4
- Subjects with serious ischemic heart disease, who are judged by the investigator or subinvestigator to be inappropriate for inclusion in the trial
- Subjects with serious arrhythmia, who are judged by the investigator or subinvestigator to be inappropriate for inclusion in the trial
- Subjects who are concomitantly undergoing peritoneal dialysis
- Subjects with ascites due to cirrhosis or cancer, requring medical treatments
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 8.0 g/dL, total bilirubin higher than 3.0 mg/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 125mEq/L
- Subjects with serum potassium higher than 6.0mEq/L and abnormal findings inappropriate for inclusion in the trial are observed by 12-lead ECG
- Subjects who are unable to sense thirst or who have difficulty with fluid or food intake
- Subjects who have participated in any other clinical trial or post-marketing clinical studies within 4 weeks prior to informed consent
- 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 From Baseline in Daily Urine Volume
The daily urine volume at each timepoint and its change and the percent change from baseline will be summarized with descriptive statistics (number, mean, standard deviation [SD], minimum, median, maximum [same for following parameters]).
Secondary Outcome Measures
Change From Baseline in Total Fluid Removal Per Week by Dialysis
The total volume of fluid removed per week by dialysis at each timepoint and its change from baseline will be summarized with descriptive statistics.
Full Information
NCT ID
NCT01876381
First Posted
June 9, 2013
Last Updated
November 30, 2017
Sponsor
Otsuka Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01876381
Brief 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 Hemodialysis or Hemodiafiltration
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 Hemodialysis or Hemodiafiltration
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 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 safety, pharmacokinetics, pharmacodynamics, and efficacy of OPC-41061 in patients with chronic renal failure undergoing hemodialysis or hemodiafiltration using variables, such as daily urine volume and increase in interval body weights between hemodialysis or hemodiafiltration, in 4-day intermittant administration (excluding the days of hemodialysis or hemodiafiltration) at the dose fixed during 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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
OPC-41061
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
OPC-41061
Intervention Description
The maximum number of days of administration will be 8 days (8 doses) in total 4 days each in the dose-escalation period and intermittant administration period. The investigational medicinal product (IMP) will be administered once daily after breakfast
Primary Outcome Measure Information:
Title
Change From Baseline in Daily Urine Volume
Description
The daily urine volume at each timepoint and its change and the percent change from baseline will be summarized with descriptive statistics (number, mean, standard deviation [SD], minimum, median, maximum [same for following parameters]).
Time Frame
Baseline and Day 14 (Intermittent Administration Period)
Secondary Outcome Measure Information:
Title
Change From Baseline in Total Fluid Removal Per Week by Dialysis
Description
The total volume of fluid removed per week by dialysis at each timepoint and its change from baseline will be summarized with descriptive statistics.
Time Frame
Baseline (pretreatment observation period) and Intermittent Administration Period (Day 10 to Day 15)
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:
Patients with chronic renal failure who are undergoing hemodialysis or hemodiafiltration three times a week
Subjects between the ages of 20 and 80, inclusive (at time of informed consent)
Subjects who are inpatients or who can be admitted to the trial site for the duration of the trial period
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
Patients who are capable of providing written informed consent themselves before any trial-related procedures are performed
Exclusion Criteria:
Subjects with a complication of urinary impairment due to urinary tract stricture, urinary calculus, tumor in urinary tract, or other cause
Subject with daily urine volume less than 500 mL
Subject with Cardiac function of NYHA class 4
Subjects with serious ischemic heart disease, who are judged by the investigator or subinvestigator to be inappropriate for inclusion in the trial
Subjects with serious arrhythmia, who are judged by the investigator or subinvestigator to be inappropriate for inclusion in the trial
Subjects who are concomitantly undergoing peritoneal dialysis
Subjects with ascites due to cirrhosis or cancer, requring medical treatments
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 8.0 g/dL, total bilirubin higher than 3.0 mg/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 125mEq/L
Subjects with serum potassium higher than 6.0mEq/L and abnormal findings inappropriate for inclusion in the trial are observed by 12-lead ECG
Subjects who are unable to sense thirst or who have difficulty with fluid or food intake
Subjects who have participated in any other clinical trial or post-marketing clinical studies within 4 weeks prior to informed consent
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 Chair
Facility Information:
City
Chube Region
Country
Japan
City
Kanto Region
Country
Japan
City
Kinki Region
Country
Japan
City
Kyushu Region
Country
Japan
City
Tohoku Region
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
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 Hemodialysis or Hemodiafiltration
We'll reach out to this number within 24 hrs