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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000001159
Receipt No. R000001409
Scientific Title Effects of modifications of CKD care systems at general practice physicians on cooperation with nephrologists and outcome of CKD patients.
Date of disclosure of the study information 2008/05/16
Last modified on 2013/05/16

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Basic information
Public title Effects of modifications of CKD care systems at general practice physicians on cooperation with nephrologists and outcome of CKD patients.
Acronym Frontier of Renal Outcome Modifications in Japan (FROM-J)
Scientific Title Effects of modifications of CKD care systems at general practice physicians on cooperation with nephrologists and outcome of CKD patients.
Scientific Title:Acronym Frontier of Renal Outcome Modifications in Japan (FROM-J)
Region
Japan

Condition
Condition chronic kidney disease
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To prevent progression of CKD stages, we constructed general practice physician's support system for CKD care.
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 Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Strict control of Japanese CKD treatment guide by general practice physician's support system for CKD care
Interventions/Control_2 Usual medical care
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
74 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. Dialysis patients
2. Patients who undergoes treatment of CKD only at nephrologists, not at general practical physicians
3. Patients who undergoes treatment of CKD at physicians who do not register this study
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 029-853-3202
Email

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
Email from-j@md.tsukuba.ac.jp

Sponsor
Institute University of Tsukuba
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2008 Year 05 Month 16 Day

Related information
URL releasing protocol http://fromj.jp/index.html
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
2008 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2008 Year 06 Month 01 Day
Last follow-up date
2014 Year 03 Month 31 Day
Date of closure to data entry
2014 Year 09 Month 30 Day
Date trial data considered complete
2015 Year 03 Month 31 Day
Date analysis concluded
2015 Year 06 Month 30 Day

Other
Other related information

Management information
Registered date
2008 Year 05 Month 16 Day
Last modified on
2013 Year 05 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001409

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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