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

ACTIVE_NOT_RECRUITINGPHASE2

Study of Tamibarotene in Patients With ADPKD

Phase IIa Clinical Trial of Tamibarotene in Patients With Autosomal Dominant Polycystic Kidney Disease

NCT06289998•Rege Nephro Co., Ltd.

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

26 - 55 years

Sex

ALL

Healthy Volunteers

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

Locations (8)

Kurume University Hospital

Kurume, Fukuoka, Japan

Hokkaido University Hospital

Sapporo, Hokkaido, Japan

Shonan Kamakura General Hospital

Kamakura, Kanagawa, Japan

Toranomon Hospital Kajigaya

Kawasaki, Kanagawa, Japan

Kyoto University Hospital

Kyoto, Kyoto, Japan

Juntendo University School of Medicine Juntendo Hospital

Bunkyo-ku, Tokyo, Japan

Toranomon Hospital

Minato-ku, Tokyo, Japan

Tokyo Women's Medical University Hospital

Shinjukuku, Tokyo, Japan

Key Dates

Start Date

December 22, 2023

Primary Completion Date

December 1, 2025

Completion Date

December 1, 2025

Last Updated

April 4, 2025

Enrollment

ESTIMATED participants

Conditions

Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Interventions

Tamibarotene

DRUG

Placebo

DRUG

Metabolic Impacts of Ren-Nu: A Dietary Program for Polycystic Kidney Disease

NCT07454174

Autosomal Dominant Polycystic Kidney Disease (ADPKD)

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ACTIVE_NOT_RECRUITING

A Possible Founding PKD2 Mutation Associated With Variable Phenotypes of ADPKD in Bergamo Province

NCT06594367

Autosomal Dominant Polycystic Kidney Disease (ADPKD)

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TERMINATEDPHASE2

Long-Term Treatment and Follow up of Subjects Completing 24 Months of Treatment With Tesevatinib on Study KD019-101

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: March 29, 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.

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Study of Tamibarotene in Patients With ADPKD

Inclusion Criteria

Exclusion Criteria

Metabolic Impacts of Ren-Nu: A Dietary Program for Polycystic Kidney Disease

A Possible Founding PKD2 Mutation Associated With Variable Phenotypes of ADPKD in Bergamo Province

Long-Term Treatment and Follow up of Subjects Completing 24 Months of Treatment With Tesevatinib on Study KD019-101

Tolvaptan Extension Study in Participants With ADPKD

Triptolide-Containing Formulation as Treatment for Autosomal Dominant Polycystic Kidney Disease (ADPKD)