UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010793 |
|---|---|
| Receipt number | 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 | 2022/11/29 16:37:53 |
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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
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
hauchida@okayama-u.ac.jp
Sponsor or person
Institute
Okayama University Hospital
Institute
Department
Personal name
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
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
| Delay expected |
Results Delay Reason
To delay in writing manuscript
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
Main results already published
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
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
All data were fixed, and writing manuscript is going
Management information
Registered date
| 2013 | Year | 05 | Month | 23 | Day |
Last modified on
| 2022 | Year | 11 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012632
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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