A Trial to Investigate the Efficacy and Safety of Orally Administered Tolvaptan (OPC-41061) in Patients With Chronic Renal Failure Undergoing Hemodialysis or Hemodiafiltration
Condition: Chronic Renal Failure
MeSH terms: Renal Insufficiency; Kidney Failure, Chronic; Renal Insufficiency, Chronic
Intervention: OPC-41061; OPC-41061; Placebo
Intervention MeSH terms: Tolvaptan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 124.0
Sex: All
Minimum age: 20 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Undergoing Hemodialysis; Undergoing Hemodiafiltration

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