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

Chronic Renal Failure Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02331680
• Other study ID #: 156-13-003
• Secondary ID: JapicCTI-142756
• Status: Completed
• Phase: Phase 2
• Start date: December 2014
• Est. completion date: May 2016

Study information

• Verified date: October 2019
• Source: Otsuka Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Renal Failure
• Kidney Failure, Chronic
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Drug:
• OPC-41061

• OPC-41061

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Daily Urine Volume	Change in daily urine volume from baseline to the end of the treatment was calculated using descriptive statistics.	Baseline,End of the treatment
Secondary	Change in Total Volume of Fluid Removed by Dialysis Per Week	Change in total volume of fluid removed by dialysis per week from baseline to the end of the treatment was calculated using descriptive statistics.	Baseline,End of the treatment