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Study of Tamibarotene in Patients With ADPKD | Clinical Trials | Clareo Health

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Active Not RecruitingPhase 2NCT06289998

Study of Tamibarotene in Patients With ADPKD

Clinical trial of tamibarotene in patients with Autosomal Dominant Polycystic Kidney Disease

Lead sponsor: Rege Nephro Co., Ltd.•8 locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Rege Nephro Co., Ltd.

Age

26 - 55 years

Sex

ALL

Healthy Volunteers

No

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: April 4, 2025Terms

Trial snapshot

StatusACTIVE_NOT_RECRUITING

PhasePHASE2

Enrollment70

Start dateDec 2023

Last updatedApr 4, 2025

Condition

Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Locations shown

Kurume University Hospital

Kurume, Fukuoka

Hokkaido University Hospital

Sapporo, Hokkaido

Shonan Kamakura General Hospital

Kamakura, Kanagawa

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 4, 2025Data synced to Clareo: May 10, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions