UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Frontier of Renal Outcome Modifications in Japan(FROM-J)cohort study
Title of the study (Brief title)	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	Kunihiro Yamagata
Organization	University of Tsukuba
Division name	Department of Nephrology,Division of Clinical Medicine, Faculty of Medicine
Address	1-1-1 Tennodai, Tsukuba, Ibaraki
TEL	029-853-3336
Email	k-yamaga@md.tsukuba.ac.jp

Public contact
Name of contact person	Chie Saito
Organization	University of Tsukuba
Division name	Department of Nephrology,Division of Clinical Medicine, Faculty of Medicine
Address	1-1-1 Tennodai, Tsukuba, Ibaraki
TEL	029-853-3202
Homepage URL
Email	fromj-info@md.tsukuba.ac.jp

Sponsor
Institute	University of Tsukuba
Institute
Department

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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2012 Year 06 Month 03 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009849