Recruitment

Recruitment Status
Completed

Inclusion Criterias

Patients diagnosed with chronic renal failure
Increase in concentration or volume of peritoneal dialysis fluid
Addition or increase of diuretics
...
Patients diagnosed with chronic renal failure
Increase in concentration or volume of peritoneal dialysis fluid
Addition or increase of diuretics
Patients who are undergoing peritoneal dialysis (continuous ambulatory peritoneal dialysis [CAPD])
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
Increase in the number of changes of peritoneal dialysis fluid

Exclusion Criterias

History of hypersensitivity or idiosyncratic reaction to benzazepine derivatives such as mozavaptan hydrochloride or benazepril hydrochloride
Daily urine volume less than 200 mL
Cardiac function of NYHA class 4
...
History of hypersensitivity or idiosyncratic reaction to benzazepine derivatives such as mozavaptan hydrochloride or benazepril hydrochloride
Daily urine volume less than 200 mL
Cardiac function of NYHA class 4
Suspected hypovolemia
History of cerebrovascular disorder or coronary artery disease within 4 weeks prior to informed consent
Subjects with any of the following abnormal laboratory values:
Urination impaired due to urinary tract stricture, urinary calculus, tumor in urinary tract, or other cause

Summary

Conditions
Chronic Renal Failure
Type
Interventional
Phase
Phase 2
Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Younger than 125 years
Gender
Both males and females

Inclusion Criterias

Patients diagnosed with chronic renal failure
Increase in concentration or volume of peritoneal dialysis fluid
Addition or increase of diuretics
...
Patients diagnosed with chronic renal failure
Increase in concentration or volume of peritoneal dialysis fluid
Addition or increase of diuretics
Patients who are undergoing peritoneal dialysis (continuous ambulatory peritoneal dialysis [CAPD])
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
Increase in the number of changes of peritoneal dialysis fluid

Exclusion Criterias

History of hypersensitivity or idiosyncratic reaction to benzazepine derivatives such as mozavaptan hydrochloride or benazepril hydrochloride
Daily urine volume less than 200 mL
Cardiac function of NYHA class 4
...
History of hypersensitivity or idiosyncratic reaction to benzazepine derivatives such as mozavaptan hydrochloride or benazepril hydrochloride
Daily urine volume less than 200 mL
Cardiac function of NYHA class 4
Suspected hypovolemia
History of cerebrovascular disorder or coronary artery disease within 4 weeks prior to informed consent
Subjects with any of the following abnormal laboratory values:
Urination impaired due to urinary tract stricture, urinary calculus, tumor in urinary tract, or other cause

Locations

Chubu Region
Hokkaido Region
Shikoku Region
Kyushu Region
Kanto Region
...
Chubu Region
Hokkaido Region
Shikoku Region
Kyushu Region
Kanto Region
Tohoku Region

Tracking Information

NCT #
NCT01895322
Collaborators
Not Provided
Investigators
Study Director: Kyoji Imaoka, Mr Otsuka Pharmaceutical Co., Ltd.