Clinical trial NCT02331680: A Trial to Investigate the Efficacy and Safety of Orally Administered Tolvaptan (OPC-41061) in Patients With Chronic Renal Failure Undergoing Hemodialysis or Hemodiafiltration
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Renal Failure
Keywords: Undergoing Hemodialysis
Undergoing Hemodiafiltration
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-01-06
Enrollment: 124
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change From Baseline in Daily Urine Volume
timeFrame: Baseline，End of the treatment
Secondary outcomes:
measure: Change in Total Volume of Fluid Removed by Dialysis Per Week
timeFrame: Baseline，End of the treatment
Other outcomes:
Locations:
city: Kanto
country: Japan
state: Region
city: Kinki
country: Japan
state: Region
city: Kyushu
country: Japan
state: Region
city: Tohoku
country: Japan
state: Region
Study officials:
affiliation: Otsuka Pharmaceutical Co., Ltd.
name: Hiroaki Ono, Mr.
role: STUDY_DIRECTOR
References: