臨床研究等提出・公開システム

Scientific Title	Post-marketing clinical trial of Pemafibrate in patients with impaired renal function
Public Title	PALT02

Contact for Scientific Queries	Name	Ishibashi Shun
	Affiliation	Jichi Medical University
	Address	3311-1 Yakushiji, Shimotsuke-shi, Tochigi-ken, Japan
	Telephone	+81-3-3279-7454
	E-mail	ctrdinfo@kowa.co.jp
Contact for Public Queries	Name	Sogabe Yukihisa
	Affiliation	Kowa Company, Ltd.
	Address	4-14, Nihonbashi-honcho 3-chome, Chuo-ku, Tokyo
	Telephone	+81-3-3279-7454
	E-mail	ctrdinfo@kowa.co.jp

Recruitment status	Complete

Anticipated date of first enrollment		Aug. 27, 2020
Actual date of first enrollment		Sept. 08, 2020
Target sample size		20
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	placebo control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1) Dyslidemia : Fasting Serum TG>=150mg/dL 2) Renal dysfunction (A:eGFR<30mL/min/1.73m^2, B:Hemodialysis, C:30<=eGFR<60mL/min/1.73m^2)
	Exclusion Criteria	1) Patients with severe liver damage, cirrhosis or biliary atresia patient 2) Patients with gallstones 3) Pregnant women or women who may be pregnant 4) Patients who have had a kidney transplant
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Dyslidemia
Intervention(s)		0.1mg, twice a day, oral
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Pharmacokinetic parameter (AUC)
Secondary Outcome(s)

Primary Sponsor	Kowa Company, Ltd.

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Review Board of Human Rights and Ethics for Clinical Studies
Address	13-2 Ichibancho, Chiyoda-ku, Tokyo
Telephone	+81-3-5213-0028
E-Mail	info@hurecs.org
Approval Status	Approval
Date of approval	July. 20, 2020

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	Mar. 30, 2022	(this page)	Changes
1	Oct. 28, 2020	Detail

List of change history