UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008378 |
|---|---|
| Receipt number | R000009849 |
| Scientific Title | Frontier of Renal Outcome Modifications in Japan(FROM-J)cohort study |
| Date of disclosure of the study information | 2012/07/08 |
| Last modified on | 2019/01/28 19:56:22 |
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Basic information
Public title
Frontier of Renal Outcome Modifications in Japan(FROM-J)cohort study
Acronym
FROM-J2
Scientific Title
Frontier of Renal Outcome Modifications in Japan(FROM-J)cohort study
Scientific Title:Acronym
FROM-J2
Region
| Japan |
Condition
Condition
chronic kidney disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate general practice physician's support system for CKD care for prevention of progression of CKD stages.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Discontinuation rate of general practice physicians consultation
2. Good communication rate between general practice physicians and nephrologists
3. Progression of CKD stages
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
| 43 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who have participated FROM-J study
Key exclusion criteria
1. Patients who is dropout from FROM-J study
2. Patients who revoke the informed consent
Target sample size
2500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kunihiro Yamagata |
Organization
University of Tsukuba
Division name
Department of Nephrology,Division of Clinical Medicine, Faculty of Medicine
Zip code
Address
1-1-1 Tennodai, Tsukuba, Ibaraki
TEL
029-853-3336
k-yamaga@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Chie Saito |
Organization
University of Tsukuba
Division name
Department of Nephrology,Division of Clinical Medicine, Faculty of Medicine
Zip code
Address
1-1-1 Tennodai, Tsukuba, Ibaraki
TEL
029-853-3202
Homepage URL
fromj-info@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Japanese Society of Nephrology
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
Address
Tel
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
筑波大学（茨城県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 07 | Month | 08 | 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
No longer recruiting
Date of protocol fixation
| 2012 | Year | 06 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 06 | Month | 03 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 03 | Month | 31 | Day |
Other
Other related information
prospective cohort study
Management information
Registered date
| 2012 | Year | 07 | Month | 08 | Day |
Last modified on
| 2019 | Year | 01 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009849
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
