UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058199 |
|---|---|
| Receipt number | R000066533 |
| Scientific Title | Fifteen-year effects of the medical support system of Frontier of Renal Outcome Modifications in Japan |
| Date of disclosure of the study information | 2025/06/16 |
| Last modified on | 2025/06/16 23:05:58 |
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Basic information
Public title
Fifteen-year effects of the medical support system of Frontier of Renal Outcome Modifications in Japan
Acronym
FROM-J15
Scientific Title
Fifteen-year effects of the medical support system of Frontier of Renal Outcome Modifications in Japan
Scientific Title:Acronym
FROM-J15
Region
| Japan |
Condition
Condition
chronic kidney disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
From April 2007 to March 2012, a study titled Research on the Efficacy of a Clinical Care System for Preventing the Progression of Chronic Kidney Disease by Promoting Collaboration Between Primary Care Physicians/Non-Nephrologists and Nephrologists (hereinafter referred to as FROM-J Study) will verify the annual rate of kidney function decline, the number of new chronic dialysis initiations, and the incidence of cardiovascular diseases between the intervention group and the non-intervention group 15 years after the completion of the cluster randomized controlled intervention trial.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Proportion of patients with CKD stage progression of two or more stages
Key secondary outcomes
eGFR decline rate
eGFR 50% decline rate
Initiation of renal replacement therapy
Cardiovascular events
Survival rate
Achievement rate of collaboration between primary care physicians and nephrologists
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 | Kunihiro |
| Middle name | |
| Last name | Yamagata |
Organization
University of Tsukuba
Division name
Department of Nephrology,Division of Clinical Medicine, Faculty of Medicine
Zip code
305-8575
Address
1-1-1 Tennodai, Tsukuba, Ibaraki
TEL
029-853-3202
k-yamaga@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Chie |
| Middle name | |
| Last name | Saito |
Organization
University of Tsukuba
Division name
Department of Nephrology,Division of Clinical Medicine, Faculty of Medicine
Zip code
305-8575
Address
1-1-1 Tennodai, Tsukuba, Ibaraki
TEL
029-853-3202
Homepage URL
chie.saito@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Cross-ministerial Strategic Innovation Promotion Program
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
University of Tsukuba
Address
1-1-1 Tennodai, Tsukuba, Ibaraki
Tel
0298533202
chie.saito@md.tsukuba.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 06 | Month | 16 | Day |
Related information
URL releasing protocol
https://reach-j.jp/wg/wg4
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
2300
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
| 2025 | Year | 03 | Month | 03 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 03 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 03 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observation study
Management information
Registered date
| 2025 | Year | 06 | Month | 16 | Day |
Last modified on
| 2025 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066533
