Clareo Health | A Trial to Investigate the Efficacy and Safety of Orally Administered Tolvaptan (OPC-41061) in Patients With Chronic Renal Failure Undergoing Hemodialysis or Hemodiafiltration
A Trial to Investigate the Efficacy and Safety of Orally Administered Tolvaptan (OPC-41061) in Patients With Chronic Renal Failure Undergoing Hemodialysis or Hemodiafiltration
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Otsuka Pharmaceutical Co., Ltd.
Age
20–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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 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
