臨床研究等提出・公開システム

Japanese

Date of registration	Dec. 22, 2023
Last modified on	July. 09, 2024
Trial ID	jRCT2011230055

Scientific Title	Phase IIa clinical trial of tamibarotene in patients with Autosomal Dominant Polycystic Kidney Disease
Public Title	Phase IIa study of tamibarotene in patients with ADPKD

Contact for Scientific Queries	Name	Hayashi Ayuto
	Affiliation	Rege Nephro Co., Ltd.
	Address	Graduate School and Faculty of Pharmaceutical Sciences, Kyoto University, 46-29, Yoshidashimoadachicho, Kyoto Sakyo-ku, Kyoto
	Telephone	+81-75-744-6858
	E-mail	info@regenephro.co.jp
Contact for Public Queries	Name	Hayashi Ayuto
	Affiliation	Rege Nephro Co., Ltd.
	Address	Graduate School and Faculty of Pharmaceutical Sciences, Kyoto University, 46-29, Yoshidashimoadachicho, Kyoto Sakyo-ku, Kyoto
	Telephone	+81-75-744-6858
	E-mail	info@regenephro.co.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Dec. 12, 2023
Actual date of first enrollment
Target sample size		70
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	single blind
	control	placebo control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	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.
	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
	Age Minimum	26age old over
	Age Maximum	55age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		Autosomal Dominant Polycystic Kidney Disease
Intervention(s)		Tamibarotene or placebo once daily for 52 weeks.
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		efficacy
Secondary Outcome(s)

Primary Sponsor	Rege Nephro Co., Ltd.

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Juntendo university institutional review board
Address	3-1-3 Hongo, Bunkyo-ku, Tokyo
Telephone	+81-3-3813-3111
E-Mail
Approval Status	Approval
Date of approval	Nov. 28, 2023

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
4	July. 09, 2024	(this page)	Changes
3	Mar. 29, 2024	Detail	Changes
2	Feb. 29, 2024	Detail	Changes
1	Dec. 22, 2023	Detail

List of change history