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Completed

NCT Number: NCT01895322

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

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.

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Key information

Conditions

Chronic Renal Failure Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Chubu Region, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OPC-41061

Drug

Primary outcomes

  1. Change in Daily Urine Volume From Baseline

    Time frame: Urine Volume on day13 minus Urine Volume at baseline(day9) on the repeated-administration period.

    Change in daily urine volume from baseline during the repeated-administration period (For five days).

  2. Percent Change in Daily Urine Volume From Baseline

    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>

    Percent change in daily urine volume from baseline during the repeated-administration period (For five days).

Secondary outcomes

  1. Change in Body Weight From Baseline

    Time frame: Body weight on day13 minus Body weight at baseline(day9) on the repeated-administration period

    Change in body weight from baseline during the repeated-administration period(For five days).

  2. Percent Change in Body Weight

    Time frame: 100%*<Body weight on day13 minus Body weight at baseline (day9)/Body weight at baseline(day9)>

    Percent change in body weight from baseline during the repeated-administration period(For five days).

Sponsors and collaborators

Lead sponsor

Otsuka Pharmaceutical Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jul 10, 2013
Registry last updated
Jan 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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