UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016787 |
|---|---|
| Receipt number | R000019448 |
| Scientific Title | An extended study in patients who completed the Japan CKD cohort study -Observational study in patients with chronic kidney disease- |
| Date of disclosure of the study information | 2015/03/31 |
| Last modified on | 2022/09/20 11:49:12 |
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Basic information
Public title
An extended study in patients who completed the Japan CKD cohort study
-Observational study in patients with chronic kidney disease-
Acronym
An extended study in patients who completed the Japan CKD cohort study
-CKD-JAC2 Study-
Scientific Title
An extended study in patients who completed the Japan CKD cohort study
-Observational study in patients with chronic kidney disease-
Scientific Title:Acronym
An extended study in patients who completed the Japan CKD cohort study
-CKD-JAC2 Study-
Region
| Japan |
Condition
Condition
chronic kidney disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate factors that affect long -term progression of clinical conditions in patients with chronic kidney disease in Japan, collecting data after the Japan CKD cohort study (the CKD-JAC study) in patients who completed the CKD-JAC study, and being integrated with CKD-JAC study data.
Basic objectives2
Others
Basic objectives -Others
Deterioration of renal function,
Cardiovascular disease related events, Death
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Deterioration of renal function,
Cardiovascular disease related events, Death
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients who completed the CKD-JAC study.
2) Patients who transferred to another hospital during the CKD-JAC study.
Key exclusion criteria
None
Target sample size
2173
Research contact person
Name of lead principal investigator
| 1st name | Masafumi |
| Middle name | |
| Last name | Fukagawa |
Organization
Japanese Society of Nephrology
Division name
-
Zip code
113-0033
Address
3-28-8, Hongo, Bunkyo-ku, Tokyo 113-0033
TEL
03-5842-4131
office@jsn.or.jp
Public contact
Name of contact person
| 1st name | Masahiko |
| Middle name | |
| Last name | Yamamoto |
Organization
Japanese Society of Nephrology
Division name
Secretariat
Zip code
113-0033
Address
3-28-8, Hongo, Bunkyo-ku, Tokyo 113-0033
TEL
03-5842-4131
Homepage URL
office@jsn.or.jp
Sponsor or person
Institute
Japanese Society of Nephrology,
Kyowa Kirin Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Japanese Society of Nephrology,
Kyowa Kirin Co., Ltd.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japanese Society of Nephrology
Address
3-28-8, Hongo, Bunkyo-ku, Tokyo 113-0033
Tel
03-5842-4131
office@jsn.or.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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 03 | Month | 31 | Day |
Related information
URL releasing protocol
https://cdn.jsn.or.jp/member/registry/Ethics-plan-doc-25.pdf
Publication of results
Published
Result
URL related to results and publications
https://academic.oup.com/ndt/advance-article/doi/10.1093/ndt/gfac134/6552146
Number of participants that the trial has enrolled
2173
Results
CGA outperformed GA classification in outcome prediction.
Results date posted
| 2022 | Year | 09 | Month | 20 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 03 | Month | 22 | Day |
Baseline Characteristics
Predialysis CKD patients who participated in the CKD-JAC study
Participant flow
1)The data center will select patients who are eligible for the study among the patients who participated in the CKD-JAC study, and contact the participating institutions.
2)Investigators, etc., investigate the necessary items and describe them in the patient list for investigation.
Adverse events
Not obtained because it is a prognostic transcription study.
Outcome measures
Deterioration of renal function
CVD event
Death
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2014 | Year | 11 | Month | 20 | Day |
Date of IRB
| 2014 | Year | 11 | Month | 20 | Day |
Anticipated trial start date
| 2015 | Year | 03 | Month | 31 | Day |
Last follow-up date
| 2018 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2018 | Year | 12 | Month | 27 | Day |
Date trial data considered complete
| 2018 | Year | 12 | Month | 27 | Day |
Date analysis concluded
Other
Other related information
multicenter, observational study
Management information
Registered date
| 2015 | Year | 03 | Month | 12 | Day |
Last modified on
| 2022 | Year | 09 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019448
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
