UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Chronic Kidney Disease and Vascular Cognitive Impairment
Title of the study (Brief title)	CKD-VCI
Region	Japan

Condition
Condition	Pre-dialysis chronic kidney disease
Classification by specialty	Nephrology Geriatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the roles of subclinical cerebrovascular disease in cognitive impairment in patients with chronic kidney disease
Basic objectives2	Others
Basic objectives -Others	To examine the roles of humoral factors including uremic toxins in cognitive impairment in patients with chronic kidney disease
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	(1) Cognitive function (2) Subclinical cerebrovascular disease by MRI
Key secondary outcomes

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	50 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patients with CKD but not yet receiving renal transplantation or dialysis treatment (Pre-dialysis CKD) 2) Out-patients or In-patients of Osaka City University Hospital 3) Patients of 50 years old or older 4) Patients who gave written informed consent
Key exclusion criteria	1) Patients due to acute or severe illness 2) Patients who are receiving medication for dementia 3) Those who are judged inappropriate by an attending physician.
Target sample size	200

Research contact person
Name of lead principal investigator	Masaaki Inaba
Organization	Osaka City University Graduate School of Medicine
Division name	Department of Metabolism, Endocrinology and Molecular Medicine
Address	1-4-3, Asahi-machi, Abeno-ku, Osaka 545-8585, Japan
TEL	06-6645-3806
Email	inaba-m@med.osaka-cu.ac.jp

Public contact
Name of contact person	Tetsuo Shoji
Organization	Osaka City University Graduate School of Medicine
Division name	Department of Vascular Medicine
Address	1-4-3, Asahi-machi, Abeno-ku, Osaka 545-8585, Japan
TEL	06-6645-3930
Homepage URL
Email	t-shoji@med.osaka-cu.ac.jp

Sponsor
Institute	Department of Metabolism, Endocrinology and Molecular Medicine & Department of Vascular Medicine, Osaka City University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
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

Other administrative information
Date of disclosure of the study information	2012 Year 12 Month 14 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 09 Month 28 Day
Anticipated trial start date	2012 Year 12 Month 31 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Main measurements: Clinical background, cognitive function, complications, ability of daily living, quality of life, physical findings, clinical laboratory data, medications

Management information
Registered date	2012 Year 10 Month 31 Day
Last modified on	2016 Year 11 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000010843