臨床研究等提出・公開システム

Date of registration	Aug. 28, 2024
Last modified on	Dec. 10, 2024
Trial ID	jRCT1041240077

Scientific Title	Pemafibrate therapy for hyperlipidemia with chronic kidney disease, including dialysis patients
Public Title	Pema-Dialysis

Contact for Scientific Queries	Name	MIMA AKIRA
	Affiliation	Nagai Hospital
	Address	29-29 Nishi-marunouchi, Tsu-city, Mie
	Telephone	+81-59-228-5181
	E-mail	akira.mima@ompu.ac.jp
Contact for Public Queries	Name	MIMA AKIRA
	Affiliation	Nagai Hospital
	Address	29-29 Nishi-marunouchi, Tsu-city, Mie
	Telephone	+81-59-228-5181
	E-mail	akira.mima@ompu.ac.jp

Recruitment status	Recruiting


Anticipated date of first enrollment		Aug. 28, 2024
Target sample size		30
Study Type		Observational
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1. serum TG more or 150 mg/dL 2. eGFR less than 20mL/min/1.73m2
	Exclusion Criteria	(1) Patients with any of the following Patients with malignant tumors Patients on immunosuppressive drugs Patients with contraindications to pemafibrate (2) Other research subjects who are judged by the principal investigator or physician in charge to be unsuitable for the safe conduct of this study.
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Chronic kidney disease patients with hypertriglyceridemia
Primary Outcome(s)		Percentage of TG concentrations achieving <150 mg/dL at 24 weeks
Secondary Outcome(s)		TG, LDL-C, HDL-C, TC, nonHDL-C, RLP-C, sdLDL-C, AST, ALT, g-GTP, ALP, creatinine, eGFR, BUN, cystatin C, blood glucose, HbA1c, insulin, HOMA-IR, GA, BNP, NT-proBNP, CPK, uric acid, Total protein, albumin, RBC, WBC, platelet count, hemoglobin, hematocrit, TNF-a, IL-6, hsCRP, FABP, urine NAG, urine b2 myoglobin, urine albumin, urine protein, urine creatinine, UACR, UPCR adverse events

Primary Sponsor	Kowa

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Nagai Hospital Clinical Research Review Board
Address	29-29 Nishi-marunouchi, Tsu-city, Mie
Telephone	+81-59-228-5181
Date of approval	Dec. 05, 2024

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	Dec. 10, 2024	(this page)	Changes
1	Aug. 28, 2024	Detail

List of change history