Study of Tamibarotene in Patients With ADPKD

Phase 2

Active, not recruiting

• Conditions: Autosomal Dominant Polycystic Kidney Disease (ADPKD)
• Interventions: Drug: Tamibarotene; Drug: Placebo

• Registration Number: NCT06289998
• Lead Sponsor: Rege Nephro Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-22
• Study First Submitted: 2024-02-18
• Study First Submitted QC: 2024-02-25
• Study First Posted: 2024-03-04
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-03
• Last Update Posted: 2025-04-04
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tamibarotene Group	Tamibarotene	-
Placebo Group	Placebo	-

Primary Outcome Measures

Name	Time	Method
Changes in TKV from baseline	52 Week after administration of Investigational Product	TKV

Secondary Outcome Measures

Name	Time	Method
Changes in TLV from baseline	52 Week after administration of Investigational Product	TLV
Changes in eGFR from baseline	52 Week after administration of Investigational Product	eGFR
Incidence of adverse events	1 year	Safety

Trial Locations

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

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

Kyoto University Hospital; 🇯🇵 Kyoto, Japan