UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009233
Receipt number R000010843
Scientific Title Chronic Kidney Disease and Vascular Cognitive Impairment
Date of disclosure of the study information 2012/12/14
Last modified on 2016/11/04 13:28:20

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Basic information

Public title

Chronic Kidney Disease and Vascular Cognitive Impairment

Acronym

CKD-VCI

Scientific Title

Chronic Kidney Disease and Vascular Cognitive Impairment

Scientific Title:Acronym

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

1st name
Middle name
Last name Masaaki Inaba

Organization

Osaka City University Graduate School of Medicine

Division name

Department of Metabolism, Endocrinology and Molecular Medicine

Zip code


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

1st name
Middle name
Last name Tetsuo Shoji

Organization

Osaka City University Graduate School of Medicine

Division name

Department of Vascular Medicine

Zip code


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 or person

Institute

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

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2012 Year 09 Month 28 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010843


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name