Clinical trial of tamibarotene in patients with Autosomal Dominant Polycystic Kidney Disease

Inclusion Criteria:

• Patients diagnosed as ADPKD by modified Pei-Ravine
• eGFR(CKD-EPI) is equal to or greater than 60 mL/min/1.73m^2
• Patients who are judged to be hard to treat with tolvaptan or who do not wish to be treated with tolvaptan, at the time of obtaining consent
• Patients with systolic blood pressure below 140 mmHg and diastolic blood pressure below 90 mmHg. For patients receiving angiotensin-converting enzyme inhibitors or angiotensin II receptor antagonists, the dose must be constant for at least 6 weeks before obtaining informed consent

Exclusion Criteria:

• Women who are pregnant or may be pregnant

• Nursing mother

• Females with childbearing potential or male subjects with a fertile partner who is unable to use contraception for the following periods:

  1. Female: From informed consent to 2 years after the last administration of the study drug
  2. Male: From informed consent to 6 months after the last administration of the study drug

• Patients within 12 weeks from the last dose of a drug that affects renal cysts, such as tolvaptan, to the first dose of the study drug

• Patients with complications of intracranial aneurysm, malignant tumor, uncontrolled diabetes, osteoporosis, uncontrolled dyslipidemia, or abnormal liver function