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

NCT02331680 | Completed Phase 2 Results

• 2 other identifiers: 156-13-003JapicCTI-142756
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 4

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.

Conditions

Chronic Renal Failure

Keywords

Undergoing Hemodialysis; Undergoing Hemodiafiltration

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in Total Volume of Fluid Removed by Dialysis Per Week

  Baseline，End of the treatment

Study Arms (3)

OPC-41061 15mg/day

EXPERIMENTAL

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

OPC-41061 30mg/day

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

OPC-41061 DRUG

Also known as: Tolvaptan

OPC-41061 15mg/day

Placebo DRUG

Also known as: Blank Tablet

Placebo

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 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

Sponsors & Collaborators

• Otsuka Pharmaceutical Co., Ltd.: lead

Study Sites (4)

Unknown Facility

Kanto, Region, Japan

Location

Unknown Facility

Kinki, Region, Japan

Location

Unknown Facility

Kyushu, Region, Japan

Location

Unknown Facility

Tōhoku, Region, Japan

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Tolvaptan

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: Otsuka Pharmaceutical Co., LTD.

+81-3-6361-7366

Study Officials

• Hiroaki Ono, Mr.

  Otsuka Pharmaceutical Co., Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2014
• First Posted: January 6, 2015
• Study Start: December 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: October 22, 2019
• Results First Posted: October 22, 2019

Record last verified: 2019-10

Locations

JP (4)