UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007655
Receipt number R000008889
Scientific Title Hiroshima-Chronic kidney disease outcomes cohort study (Hi-COCS)
Date of disclosure of the study information 2012/04/03
Last modified on 2024/10/21 09:29:51

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Basic information

Public title

Hiroshima-Chronic kidney disease outcomes cohort study (Hi-COCS)

Acronym

Chronic kidney disease and outcomes

Scientific Title

Hiroshima-Chronic kidney disease outcomes cohort study (Hi-COCS)

Scientific Title:Acronym

Chronic kidney disease and outcomes

Region

Japan


Condition

Condition

Chronic kidney disease

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify incident rates of death in chronic kidney disease patients

Basic objectives2

Others

Basic objectives -Others

To clarify incident rates of complication in chronic kidney disease patients

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

death

Key secondary outcomes

Incident of complication


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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who underwent renal biopsy or start dialysis

Key exclusion criteria

Patients who are younger than 20 years old and will move out of Hiroshima prefecture after renal biopsy or induction for daialysis

Target sample size

5000


Research contact person

Name of lead principal investigator

1st name Takao
Middle name
Last name MASAKI

Organization

Hiroshima University Hospital

Division name

Department of Nephrology

Zip code

734-8551

Address

1-2-3 Kasumi Minami-ku, Hiroshima,

TEL

082-257-1506

Email

masakit@hiroshima-u.ac.jp


Public contact

Name of contact person

1st name Takao
Middle name
Last name Masaki

Organization

Hiroshima University Hospital

Division name

Department of Nephrology

Zip code

734-8551

Address

1-2-3 Kasumi Minami-ku, Hiroshima,

TEL

082-257-1506

Homepage URL


Email

masakit@hiroshima-u.ac.jp


Sponsor or person

Institute

Department of Nephrology, Hiroshima University Hospital

Institute

Department

Personal name



Funding Source

Organization

Department of Nephrology, Hiroshima University Hospital

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Hiroshima University hospital IRB

Address

1-2-3 Kasumi Minami-ku, Hiroshima,Japan

Tel

082-257-5596

Email

hugcp@hiroshima-u.ac.jp


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

広島大学病院(広島県)、尾道クリニック(広島県)、尾道総合病院(広島県)、中央内科クリニック(広島県)、呉共済病院(広島県)、呉医療センター(広島県)、博愛クリニック(広島県)、広島ベイクリニック(広島県)、小田内科クリニック(広島県)、県立広島病院(広島県)、イーストクリニック(広島県)、横川クリニック(広島県)、井口医院(広島県)、一陽会原田病院(広島県)、広島総合病院(広島県)、あかね会土谷総合病院(広島県)、中島土谷クリニック(広島県)、大町土谷クリニック(広島県)


Other administrative information

Date of disclosure of the study information

2012 Year 04 Month 03 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

Open public recruiting

Date of protocol fixation

2011 Year 05 Month 26 Day

Date of IRB

2011 Year 11 Month 01 Day

Anticipated trial start date

2012 Year 03 Month 01 Day

Last follow-up date

2031 Year 09 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

incident of event


Management information

Registered date

2012 Year 04 Month 03 Day

Last modified on

2024 Year 10 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008889