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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000010793
Receipt No. R000012632
Scientific Title Prospective cohort study of patients with CKD and development of medical system for CKD and CVD
Date of disclosure of the study information 2013/05/24
Last modified on 2020/05/29

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Basic information
Public title Prospective cohort study of patients with CKD and development of medical system for CKD and CVD
Acronym Kakusyo CKD/CVD cohort (3C) study
Scientific Title Prospective cohort study of patients with CKD and development of medical system for CKD and CVD
Scientific Title:Acronym Kakusyo CKD/CVD cohort (3C) study
Region
Japan

Condition
Condition Chronic Kidney Disease
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of the current study is to prospective follow patients with CKD including high risk patients for CVD in associated hospitals of Okayama University Hospital, and to evaluate risk factors and predictive factors for progression of CKD, ESRD, CVD onset and death.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Others
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes 1. Composite renal endpoint (ESRD, 50% reduction of eGFR and death)
2. Onset of cardiovascular events
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
20 years-old <=
Age-upper limit
75 years-old >
Gender Male and Female
Key inclusion criteria Patients with chronic kidney disease
Key exclusion criteria Patients on dialysis and patients receiving renal transplantation
Target sample size 1200

Research contact person
Name of lead principal investigator
1st name Haruhito
Middle name A
Last name Uchida
Organization Okayama Univ. Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name Dept. of CKD and CVD
Zip code 7008558
Address 2-5-1, Shikata-cho, Kita-ku, Okayama city
TEL 086-235-7235
Email hauchida@okayama-u.ac.jp

Public contact
Name of contact person
1st name Haruhito
Middle name A
Last name Uchida
Organization Okayama Univ. Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name Dept. of CKD and CVD
Zip code 7008558
Address 2-5-1,Shikata-cho, Kita-ku, Okayama city
TEL 086-235-7235
Homepage URL
Email hauchida@okayama-u.ac.jp

Sponsor
Institute Okayama University Hospital
Institute
Department

Funding Source
Organization Okayama Univ. Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization Ethics Committee, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital
Address 2-5-1 Shikata-cho, Kita-ku, Okayama city
Tel 086-235-6503
Email mae6605@adm.okayama-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 岡山大学病院、岡山大学病院関連施設

Other administrative information
Date of disclosure of the study information
2013 Year 05 Month 24 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 200
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 No longer recruiting
Date of protocol fixation
2012 Year 09 Month 01 Day
Date of IRB
2012 Year 10 Month 23 Day
Anticipated trial start date
2013 Year 05 Month 25 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
2021 Year 06 Month 01 Day
Date trial data considered complete
2021 Year 09 Month 01 Day
Date analysis concluded
2022 Year 03 Month 31 Day

Other
Other related information Registration of subjects was closed.

Management information
Registered date
2013 Year 05 Month 23 Day
Last modified on
2020 Year 05 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012632

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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