UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Biomarkers for cardiovascular disease in chronic kidney disease
Title of the study (Brief title)	Biomarkers for cardiovascular disease in chronic kidney disease
Region	Japan

Condition
Condition	chronic kidney disease
Classification by specialty	Cardiology Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We investigated the relationship between biomarkers for cardiovascular disease and clinical parameters in CKD patients.
Basic objectives2	Others
Basic objectives -Others	None
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	relationship between clinical parameters and biomarkers for cardiovascular disease
Key secondary outcomes	None

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	CKD patients who admitted in our hospital from December 2014 to December 2015
Key exclusion criteria	Patients who reject the participation of this study
Target sample size	1050

Research contact person
Name of lead principal investigator	Shinichi Nishi
Organization	Kobe university graduate school of medicine
Division name	Division of Nephrology
Address	7-5-2 kusunoki cho, chuou ku, Kobe city
TEL	078-382-6500
Email	snishi@med.kobe-u.ac.jp

Public contact
Name of contact person	Hideki Fujii
Organization	Kobe university graduate school of medicine
Division name	Division of Nephrology
Address	7-5-2 kusunoki cho, chuou ku, Kobe city
TEL	078-382-6500
Homepage URL	http://www.med.kobe-u.ac.jp/kidney/index.html
Email	fhideki@med.kobe-u.ac.jp

Sponsor
Institute	Division of nephrology, Kobe university graduate school of medicine
Institute
Department

Funding Source
Organization	Roche diagnostics
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	神戸大学病院（兵庫県）

Other administrative information
Date of disclosure of the study information	2017 Year 10 Month 30 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2016 Year 06 Month 01 Day
Anticipated trial start date	2016 Year 06 Month 01 Day
Last follow-up date	2020 Year 01 Month 01 Day
Date of closure to data entry	2020 Year 01 Month 01 Day
Date trial data considered complete	2020 Year 06 Month 01 Day
Date analysis concluded	2020 Year 12 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	None

Management information
Registered date	2017 Year 10 Month 30 Day
Last modified on	2017 Year 10 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033999