UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009783
Receipt number R000011317
Scientific Title Prospective cohort study of silent brain damage in chronic kidney disease(CKD) patients.
Date of disclosure of the study information 2013/04/10
Last modified on 2019/03/31 19:46:05

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Basic information

Public title

Prospective cohort study of silent brain damage in chronic kidney disease(CKD) patients.

Acronym

SBI-CKD

Scientific Title

Prospective cohort study of silent brain damage in chronic kidney disease(CKD) patients.

Scientific Title:Acronym

SBI-CKD

Region

Japan


Condition

Condition

Chronic kidney disease (CKD)

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify the predictive value of silent brain damage for global outcome in patients with chronic kidney disease

Basic objectives2

Others

Basic objectives -Others

Examination about other complications

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Composite of kidney function loss, new onset of cerebro/cardio-vascular disease, and mortality

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

16 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

presence of CKD

Key exclusion criteria

malignancy
hereditary renal disease
polycystic kidney disease
patients without written informed consent

Target sample size

500


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Eiji Ishimura

Organization

Osaka City University Graduate School of Medicine

Division name

Department of Nephrology

Zip code


Address

1-4-3, Asahimachi, Abeno-ku, Osaka-shi

TEL

06-6645-3806

Email

ish@med.osaka-cu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hideaki Shima

Organization

Osaka Medical College

Division name

Nephrology

Zip code


Address

2-7, daigaku-machi, Takatsuki-shi

TEL

072-683-1221

Homepage URL


Email

in3130@poh.osaka-med.ac.jp


Sponsor or person

Institute

Osaka City University Graduate School of Medicine
Department of Nephrology

Institute

Department

Personal name



Funding Source

Organization

none

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

大阪市立大学医学部附属病院(大阪府)、大野記念病院(大阪府)


Other administrative information

Date of disclosure of the study information

2013 Year 04 Month 10 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

https://www.ncbi.nlm.nih.gov/pubmed/27354659

Number of participants that the trial has enrolled


Results

1) Higher prevalence of cerebral microbleeds in patients with more advanced stages of CKD.
2) Higher prevalence and severity of white matter lesions in patients with more advanced stages of CKD.
3) Silent microbleeds is new predictor of future kidney outcome and CVD events.

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

2008 Year 08 Month 31 Day

Date of IRB

2008 Year 08 Month 28 Day

Anticipated trial start date

2008 Year 09 Month 30 Day

Last follow-up date

2013 Year 09 Month 30 Day

Date of closure to data entry

2016 Year 09 Month 30 Day

Date trial data considered complete

2016 Year 09 Month 30 Day

Date analysis concluded

2018 Year 08 Month 15 Day


Other

Other related information

Silent Cerebral Microbleeds and Longitudinal Risk of Renal and Cardiovascular Events in Patients with CKD.
Clin J Am Soc Nephrol 2016 Sep 7;11(9):1557-65
PMID: 27354659


Management information

Registered date

2013 Year 01 Month 15 Day

Last modified on

2019 Year 03 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011317


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name