Clinical Trials in Japan / NCT06289998
Active, not recruiting
Phase 2
Study of Tamibarotene in Patients With ADPKD
NCT06289998 · tracked via the Priya Life Science Japan tracker
Condition(s) studied
Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Investigational drug(s) / intervention(s)
Tamibarotene →Placebo
Tamibarotene: Subjects are administrated to tamibarotene 4 mg in daily for 52 weeks.
Placebo: Subjects are administrated to placebo in daily for 52 weeks.
Study summary
Clinical trial of tamibarotene in patients with Autosomal Dominant Polycystic Kidney Disease
Eligibility
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
Primary outcome measure(s)
- Changes in TKV from baseline — 52 Week after administration of Investigational Product
TKV
Trial sites (8)
| Facility | City | Region | Status |
|---|---|---|---|
| Kurume University Hospital | Kurume | Fukuoka | |
| Hokkaido University Hospital | Sapporo | Hokkaido | |
| Shonan Kamakura General Hospital | Kamakura | Kanagawa | |
| Toranomon Hospital Kajigaya | Kawasaki | Kanagawa | |
| Kyoto University Hospital | Kyoto | Kyoto | |
| Juntendo University School of Medicine Juntendo Hospital | Bunkyo-ku | Tokyo | |
| Toranomon Hospital | Minato-ku | Tokyo | |
| Tokyo Women's Medical University Hospital | Shinjukuku | Tokyo |
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06289998 on ClinicalTrials.gov ↗ ← All trials in Japan