臨床研究等提出・公開システム

Scientific Title	Influence of iron sufficiency factors by inflammatory status on prognosis in hemodialysis patients: The Japanese Dialysis Outcomes and Practice Pattern Study (J-DOPPS)
Public Title	Influence of iron sufficiency factors by inflammatory status on prognosis in hemodialysis patients: The Japanese Dialysis Outcomes and Practice Pattern Study (J-DOPPS)

Contact for Scientific Queries	Name	Eriguchi Masahiro
	Affiliation	Nara Medical Univrsity
	Address	840 Shijocho, Kashihara, Nara, 634-8521, Japan
	Telephone	+81-744-29-8865
	E-mail	meriguci@gmail.com
Contact for Public Queries	Name	Eriguchi Masahiro
	Affiliation	Nara Medical Univrsity
	Address	840 Shijocho, Kashihara, Nara, 634-8521, Japan
	Telephone	+81-744-29-8865
	E-mail	meriguci@gmail.com

Recruitment status	Not Recruiting

Anticipated date of first enrollment		Jan. 14, 2025
Actual date of first enrollment
Target sample size		5000
Study Type		Observational
Study Design	allocation
	masking
	control
	assignment
	purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Individuals who meet the following criteria are eligible for inclusion in the J-DOPPS database: Have been diagnosed with chronic kidney disease. Are undergoing hemodialysis treatment. Are 18 years of age or older.
	Exclusion Criteria	Exclusion criteria for the J-DOPPS database: Patients undergoing blood purification therapies other than hemodialysis. Patients receiving home hemodialysis. Patients with acute kidney injury. Exclusion criteria for this study: Patients without available baseline TIBC values.
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender
Health Condition(s) or Problem(s) Studied		Outpatients undergoing maintenance hemodialysis in Japanese dialysis facilities
Intervention(s)
Health Condition(s) Keyword		End-stage kidney disease, hemodialysis, total iron binding capacity, prognosis, nutritional status, chronic inflammation
Intervention(s) Keyword
Health Condition(s) Code		D051436
Intervention(s) Code
Primary Outcome(s)		All-cause mortality
Secondary Outcome(s)		Hospitalization or mortality resulting from cardiovascular and thromboembolic events Cardiovascular and thromboembolic events leading to hospitalization or death

Primary Sponsor	None

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support	Astellas Pharma Inc.
Secondary Sponsor

Name of Certified Review Board	Nara Medical University Certified Review Board
Address	840 Shijocho, Kashihara, Nara, 634-8521, Japan, Nara
Telephone	+81-744298865
E-Mail	meriguci@gmail.com
Approval Status	Approval
Date of approval

Plan to share IPD
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	None