Autosomal Dominant Polycystic Kidney Disease
Conditions
Interventions
Tamibarotene or placebo once daily for 52 weeks.
Sponsors
Hayashi Ayuto
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy | — |
Contacts
Public ContactAyuto Hayashi
Rege Nephro Co., Ltd.
Outcome results
None listed