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A Trial to Investigate the Efficacy and Safety of Orally Administered Tolvaptan (OPC-41061) in Patients With Chronic Renal Failure Undergoing Hemodialysis or Hemodiafiltration

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ClinicalTrials.gov Identifier: NCT02331680
Recruitment Status : Completed
First Posted : January 6, 2015
Last Update Posted : March 10, 2017
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.

Brief Summary:
This is a study to investigate the efficacy and safety of OPC-41061 by 24-week oral administration of OPC-41061 at 15-mg or 30-mg or placebo in patients with chronic renal failure who are undergoing hemodialysis or hemodiafiltration and who have daily urine volume of at least 500 mL/day.

Condition or disease Intervention/treatment Phase
Chronic Renal Failure Drug: OPC-41061 Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Multicenter, Placebo-controlled, Double-blind, Randomized, Parallel-group Trial to Investigate the Efficacy and Safety of Orally Administered Tolvaptan (OPC-41061) in Patients With Chronic Renal Failure Undergoing Hemodialysis or Hemodiafiltration
Study Start Date : December 2014
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Tolvaptan

Arm Intervention/treatment
Experimental: OPC-41061 15mg/day
Will be orally administered once daily after breakfast on all days on which subjects do not undergo dialysis. OPC-41061 at 15 mg/day will be administered for 24 week.
Drug: OPC-41061
Other Name: Tolvaptan

Experimental: OPC-41061 30mg/day
Will be orally administered once daily after breakfast on all days on which subjects do not undergo dialysis. OPC-41061 at 15 mg/day will be administered for 1 week and then OPC-41061 30 mg/day for 23 weeks
Drug: OPC-41061
Other Name: Tolvaptan

Placebo Comparator: Placebo
Will be orally administered once daily after breakfast on all days on which subjects do not undergo dialysis. Placebo will be administered for 24 week.
Drug: Placebo
Other Name: Blank Tablet




Primary Outcome Measures :
  1. Change from baseline in daily urine volume for 24weeks [ Time Frame: Baseline, 2, 4, 8, 12, 16, 20, and 24weeks ]

Secondary Outcome Measures :
  1. Total fluid removal volume by dialysis per week [ Time Frame: Baseline, 2, 4, 8, 12, 16, 20, and 24weeks ]


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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronic renal failure requiring hemodialysis or hemodiafiltration 3 times a week
  • Daily urine volume of ≥ 500 mL/day
  • Male or female patients age 20 to 80 years, inclusive
  • Use of one of the specified contraceptive methods until 4 weeks after final IMP administration
  • Capable of providing their own written informed consent prior to any trial-related procedures being performed

Exclusion Criteria:

  • Patients with a complication of urinary impairment due to urinary tract stricture, urinary calculus, tumor in urinary tract, or other cause
  • Patients with NYHA class IV heart failure
  • Patients with impaired hepatic function(chronic hepatitis, drug-induced liver injury)
  • Patients with serious ischemic heart disease who are judged by the investigator or subinvestigator to be inappropriate for inclusion in the trial
  • Patients with serious arrhythmia who are judged by the investigator or subinvestigator to be inappropriate for inclusion in the trial
  • Patients with serious secondary hyperparathyroidism(intact parathyroid hormone > 500 pg/mL)
  • Patients who are concomitantly undergoing peritoneal dialysis
  • Patients with a history of cerebrovascular disease or coronary artery disease within 4 weeks prior to informed consent, a history of hypersensitivity to any ingredient of tolvaptan or benzazepine derivatives such as mozavaptan hydrochloride or a history of impaired hepatic function(chronic hepatitis, drug-induced liver injury)
  • Patients with any of the following abnormal laboratory values: hemoglobin < 8.0 g/dL, total bilirubin > 3.0 mg/dL, ALT (GPT) or AST (GOT) > 2 times the upper limit of the reference range, serum sodium > upper limit of the reference range, serum sodium < 125 mEq/L, or serum potassium > 6.0 mEq/L
  • Patients who are unable to sense thirst or who have difficulty with fluid intake
  • Patients who have received OPC-41061 in history.
  • Participation in any other clinical trial or post-marketing clinical study within 4 weeks prior to informed consent for the present trial
  • Female patients who are pregnant, possibly pregnant, or nursing
  • Patients otherwise judged by the investigator or subinvestigator to be inappropriate for inclusion in the trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02331680


Locations
Japan
Kanto, Region, Japan
Kinki, Region, Japan
Kyushu, Region, Japan
Tohoku, Region, Japan
Sponsors and Collaborators
Otsuka Pharmaceutical Co., Ltd.
Investigators
Study Director: Hiroaki Ono, Mr. Otsuka Pharmaceutical Co., Ltd.

Responsible Party: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT02331680     History of Changes
Other Study ID Numbers: 156-13-003
JapicCTI-142756 ( Other Identifier: Japic )
First Posted: January 6, 2015    Key Record Dates
Last Update Posted: March 10, 2017
Last Verified: March 2017

Keywords provided by Otsuka Pharmaceutical Co., Ltd.:
Undergoing Hemodialysis
Undergoing Hemodiafiltration

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases
Tolvaptan
Antidiuretic Hormone Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Physiological Effects of Drugs