UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035702 |
|---|---|
| Receipt number | R000040668 |
| Scientific Title | Ten-year effects of the medical support system of Frontier of Renal Outcome Modifications in Japan |
| Date of disclosure of the study information | 2019/01/28 |
| Last modified on | 2023/04/08 02:22:49 |
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Basic information
Public title
Ten-year effects of the medical support system of Frontier of Renal Outcome Modifications in Japan
Acronym
FROM-J 10
Scientific Title
Ten-year effects of the medical support system of Frontier of Renal Outcome Modifications in Japan
Scientific Title:Acronym
FROM-J 10
Region
| Japan |
Condition
Condition
chronic kidney disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the utility of clinical practice system for CKD patients who attended FROM-J study by use of their renal outcomeand prognosis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
multi end points: cardiovascular disease,renal replacement therapy and 50% reduction rate of eGFR.
Key secondary outcomes
1.survival rate
2. yearly decline of eGFR
3. coalition between general physician and nephrologist
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
| 40 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients with CKD stage 1,2,4 or 5.
2. Patients with CKD stage 3 who have proteinuria, also with diabetes mellitus or hypertension
Key exclusion criteria
1. Patients who did not attend FROM-J study.
2. Patients who attend FROM-J study but did not consent to attend follow-up study.
Target sample size
2300
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
029-853-3202
reach-j@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
reach-j@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 01 | Month | 28 | 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
| 2018 | Year | 11 | Month | 12 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 12 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
| 2020 | Year | 11 | Month | 01 | Day |
Date trial data considered complete
| 2021 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 01 | Day |
Other
Other related information
Study design: cohort study
Subject: CKD patients who attended FROM-J study
primary endpoint: multi endpoint(CVD, RRT and 50% reduction rate of eGFR)
Management information
Registered date
| 2019 | Year | 01 | Month | 28 | Day |
Last modified on
| 2023 | Year | 04 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040668
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
