Study of Tamibarotene in Patients With ADPKD

Autosomal Dominant Polycystic Kidney Disease (ADPKD) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06289998
• Other study ID #: RP014-01
• Status: Recruiting
• Phase: Phase 2
• Start date: December 22, 2023
• Est. completion date: December 2025

Study information

• Verified date: February 2024
• Source: Rege Nephro Co., Ltd.
• Contact: Ayuto Hayashi
• Phone: +81 75-744-6858
• Email: info[@]regenephro.co.jp
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 26 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthrogryposis
• Autosomal Dominant Polycystic Kidney Disease (ADPKD)
• Kidney Diseases
• Polycystic Kidney Diseases
• Polycystic Kidney, Autosomal Dominant

Intervention

Drug:
• Tamibarotene
Subjects are administrated to tamibarotene 4 mg in daily for 52 weeks.
• Placebo
Subjects are administrated to placebo in daily for 52 weeks.

Locations

Country	Name	City	State
Japan	Juntendo University School of Medicine Juntendo Hospital	Bunkyo-ku	Tokyo
Japan	Shonan Kamakura General Hospital	Kamakura	Kanagawa
Japan	Toranomon Hospital Kajigaya	Kawasaki	Kanagawa
Japan	Kurume University Hospital	Kurume	Fukuoka
Japan	Kyoto University Hospital	Kyoto
Japan	Toranomon Hospital	Minato-ku	Tokyo
Japan	Hokkaido University Hospital	Sapporo	Hokkaido
Japan	Tokyo Women's Medical University Hospital	Shinjukuku	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Rege Nephro Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in TKV from baseline	TKV	52 Week after administration of Investigational Product
Secondary	Changes in TLV from baseline	TLV	52 Week after administration of Investigational Product
Secondary	Changes in eGFR from baseline	eGFR	52 Week after administration of Investigational Product
Secondary	Incidence of adverse events	Safety	1 year