Ireland
--:--IST
Active, not recruiting Phase 2

Study of Tamibarotene in Patients With ADPKD

NCT06289998 · tracked via the Priya Life Science Japan tracker
Sponsor
Rege Nephro Co., Ltd
Phase
Phase 2
Started
2023-12-22
Last updated
2025-04-04

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

Sex
ALL
Min age
26 Years
Max age
55 Years
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

Primary outcome measure(s)

  • Changes in TKV from baseline — 52 Week after administration of Investigational Product
    TKV

Trial sites (8)

FacilityCityRegionStatus
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