Open-label Dose-finding Trial of OPC-41061 in Patients With Chronic Renal Failure Undergoing Peritoneal Dialysis
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
2 other identifiers
interventional
20
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jul 2013
Shorter than P25 for phase_2
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2013
CompletedFirst Submitted
Initial submission to the registry
July 4, 2013
CompletedFirst Posted
Study publicly available on registry
July 10, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedResults Posted
Study results publicly available
January 1, 2016
CompletedJanuary 1, 2016
November 1, 2015
7 months
July 4, 2013
August 21, 2015
November 30, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in Daily Urine Volume From Baseline
Change in daily urine volume from baseline during the repeated-administration period (For five days).
Urine Volume on day13 minus Urine Volume at baseline(day9) on the repeated-administration period.
Percent Change in Daily Urine Volume From Baseline
Percent change in daily urine volume from baseline during the repeated-administration period (For five days).
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 Outcomes (2)
Change in Body Weight From Baseline
Body weight on day13 minus Body weight at baseline(day9) on the repeated-administration period
Percent Change in Body Weight
100%*<Body weight on day13 minus Body weight at baseline (day9)/Body weight at baseline(day9)>
Study Arms (1)
OPC-41061
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Unknown Facility
Chubu Region, Japan
Unknown Facility
Hokkaido Region, Japan
Unknown Facility
Kanto Region, Japan
Unknown Facility
Kyushu Region, Japan
Unknown Facility
Shikoku Region, Japan
Unknown Facility
Tohoku Region, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director of Clinical Research and Development
- Organization
- Otsuka Pharmaceutical Co., Ltd
Study Officials
- STUDY DIRECTOR
Kyoji Imaoka, Mr
Otsuka Pharmaceutical Co., Ltd.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 4, 2013
First Posted
July 10, 2013
Study Start
July 1, 2013
Primary Completion
February 1, 2014
Study Completion
August 1, 2014
Last Updated
January 1, 2016
Results First Posted
January 1, 2016
Record last verified: 2015-11