Phase IIa study of tamibarotene in patients with ADPKD

JRCT ID: jRCT2011230055

Registered date:22/12/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Autosomal Dominant Polycystic Kidney Disease
• Date of first enrollment: 12/12/2023
• Target sample size: 70
• Study type: Interventional
• Intervention(s): Tamibarotene or placebo once daily for 52 weeks.

Outcome(s)

• Primary Outcome: efficacy

Key inclusion & exclusion criteria

• Age minimum: >= 26age old
• Age maximum: <= 55age old
• Gender: Both

Include 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.

Exclude 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

Related Information

• Primary Sponsor: Hayashi Ayuto