Clinical trial NCT01895322: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Renal Failure
Keywords: Tolvaptan
dialysis
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2013-07-10
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in Daily Urine Volume From Baseline
timeFrame: Urine Volume on day13 minus Urine Volume at baseline(day9) on the repeated-administration period.
measure: Percent Change in Daily Urine Volume From Baseline
timeFrame: 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:
measure: Change in Body Weight From Baseline
timeFrame: Body weight on day13 minus Body weight at baseline(day9) on the repeated-administration period
measure: Percent Change in Body Weight
timeFrame: 100%*<Body weight on day13 minus Body weight at baseline (day9)/Body weight at baseline(day9)>
Other outcomes:
Locations:
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
Study officials:
affiliation: Otsuka Pharmaceutical Co., Ltd.
name: Kyoji Imaoka, Mr
role: STUDY_DIRECTOR
References: