NCT06289998Active, not recruitingPhase 2
Study of Tamibarotene in Patients With ADPKD
Phase IIa Clinical Trial of Tamibarotene in Patients With Autosomal Dominant Polycystic Kidney Disease
Source: ClinicalTrials.gov · Last updated 4 Apr 2025
Brief summary (registry, in English)
Clinical trial of tamibarotene in patients with Autosomal Dominant Polycystic Kidney Disease
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 70 (estimated)
- First submitted
- 18 Feb 2024
- Start date
- 22 Dec 2023
- Primary completion date
- Dec 2025
- Lead sponsor
- Rege Nephro Co., Ltd.
- Diseases
- Polycystic kidney disease
- NCT number
- NCT06289998
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 70
- From 22 Dec 2023 to the primary completion date, Dec 2025
- 8 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Females with childbearing potential or male subjects with a fertile partner who is unable to use contraception for the following periods:
- Female: From informed consent to 2 years after the last administration of the study drug
- 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
Other illness
- Patients with complications of intracranial aneurysm, malignant tumor, uncontrolled diabetes, osteoporosis, uncontrolled dyslipidemia, or abnormal liver function
Other
- Women who are pregnant or may be pregnant
- Nursing mother
Who the study is looking for
- 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
Age in the registry: 26 years to 55 years · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Juntendo University School of Medicine Juntendo Hospital Coordinator of this site? Confirm its status | Bunkyō-Ku | Japan | Unknown status |
| Shonan Kamakura General Hospital Coordinator of this site? Confirm its status | Kamakura | Japan | Unknown status |
| Toranomon Hospital Kajigaya Coordinator of this site? Confirm its status | Kawasaki | Japan | Unknown status |
| Kurume University Hospital Coordinator of this site? Confirm its status | Kurume | Japan | Unknown status |
| Kyoto University Hospital Coordinator of this site? Confirm its status | Kyoto | Japan | Unknown status |
| Toranomon Hospital Coordinator of this site? Confirm its status | Minato-ku | Japan | Unknown status |
| Hokkaido University Hospital Coordinator of this site? Confirm its status | Sapporo | Japan | Unknown status |
| Tokyo Women's Medical University Hospital Coordinator of this site? Confirm its status | Shinjukuku | Japan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.