Phase IIa Clinical Trial of Tamibarotene in Patients With Autosomal Dominant Polycystic Kidney Disease

RP014-01

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

2023-12-22

2025-12-01

2025-12-01

Recruiting

Early phase I

70

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 70, 'type': 'ESTIMATED'}}

2024-03-04