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 Hemodialysis or Hemodiafiltration

NCT01876381 | Completed Phase 2 Results

• 2 other identifiers: 156-12-007JapicCTI-132147
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 5

Brief Summary

To investigate the safety, pharmacokinetics, pharmacodynamics, and efficacy of OPC-41061 in patients with chronic renal failure undergoing hemodialysis or hemodiafiltration using variables, such as daily urine volume and increase in interval body weights between hemodialysis or hemodiafiltration, in 4-day intermittant administration (excluding the days of hemodialysis or hemodiafiltration) at the dose fixed during the dose-escalation period

Conditions

Chronic Renal Failure

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Daily Urine Volume

  The daily urine volume at each timepoint and its change and the percent change from baseline will be summarized with descriptive statistics (number, mean, standard deviation \[SD\], minimum, median, maximum \[same for following parameters\]).

  Baseline and Day 14 (Intermittent Administration Period)

Secondary Outcomes (1)

• Change From Baseline in Total Fluid Removal Per Week by Dialysis

  Baseline (pretreatment observation period) and Intermittent Administration Period (Day 10 to Day 15)

Study Arms (1)

OPC-41061

EXPERIMENTAL

Drug: OPC-41061

Interventions

OPC-41061 DRUG

The maximum number of days of administration will be 8 days (8 doses) in total 4 days each in the dose-escalation period and intermittant administration period. The investigational medicinal product (IMP) will be administered once daily after breakfast

OPC-41061

Eligibility Criteria

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

You may qualify if:

• Patients with chronic renal failure who are undergoing hemodialysis or hemodiafiltration three times a week
• Subjects between the ages of 20 and 80, inclusive (at time of informed consent)
• Subjects who are inpatients or who can be admitted to the trial site for the duration of the trial period
• 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
• Patients who are capable of providing written informed consent themselves before any trial-related procedures are performed

You may not qualify if:

• Subjects with a complication of urinary impairment due to urinary tract stricture, urinary calculus, tumor in urinary tract, or other cause
• Subject with daily urine volume less than 500 mL
• Subject with Cardiac function of NYHA class 4
• Subjects who are concomitantly undergoing peritoneal dialysis
• Subjects with ascites due to cirrhosis or cancer, requring medical treatments
• 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 8.0 g/dL, total bilirubin higher than 3.0 mg/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 125mEq/L
• Subjects who are unable to sense thirst or who have difficulty with fluid or food intake
• Subjects who have participated in any other clinical trial or post-marketing clinical studies within 4 weeks prior to informed consent
• Female subjects who are pregnant, possibly pregnant, or nursing, or who plan to become pregnant during the trial period

Sponsors & Collaborators

• Otsuka Pharmaceutical Co., Ltd.: lead

Study Sites (5)

Unknown Facility

Chube Region, Japan

Location

Unknown Facility

Kanto Region, Japan

Location

Unknown Facility

Kinki Region, Japan

Location

Unknown Facility

Kyushu Region, Japan

Location

Unknown Facility

Tohoku 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

• Kyoji Imaoka, Mr

  Otsuka Pharmaceutical Co., Ltd.

  STUDY CHAIR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2013
• First Posted: June 12, 2013
• Study Start: June 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: August 24, 2018
• Results First Posted: August 24, 2018

Record last verified: 2017-11

Locations

JP (5)