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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.
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

Full criteria on ClinicalTrials.gov

Sites (8)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Juntendo University School of Medicine Juntendo Hospital
Coordinator of this site? Confirm its status
Bunkyō-KuJapanUnknown status
Shonan Kamakura General Hospital
Coordinator of this site? Confirm its status
KamakuraJapanUnknown status
Toranomon Hospital Kajigaya
Coordinator of this site? Confirm its status
KawasakiJapanUnknown status
Kurume University Hospital
Coordinator of this site? Confirm its status
KurumeJapanUnknown status
Kyoto University Hospital
Coordinator of this site? Confirm its status
KyotoJapanUnknown status
Toranomon Hospital
Coordinator of this site? Confirm its status
Minato-kuJapanUnknown status
Hokkaido University Hospital
Coordinator of this site? Confirm its status
SapporoJapanUnknown status
Tokyo Women's Medical University Hospital
Coordinator of this site? Confirm its status
ShinjukukuJapanUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.