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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000011211
Receipt No. R000013135
Scientific Title Prospective survey of the patient characteristics and outcomes for outpatient nephrology clinics in Miyagi Prefecture
Date of disclosure of the study information 2013/07/18
Last modified on 2017/07/19

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Basic information
Public title Prospective survey of the patient characteristics and outcomes for outpatient nephrology clinics in Miyagi Prefecture
Acronym The Gonryo Study
Scientific Title Prospective survey of the patient characteristics and outcomes for outpatient nephrology clinics in Miyagi Prefecture
Scientific Title:Acronym The Gonryo Study
Region
Japan

Condition
Condition Chronic Kidney Disease
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the clinical outcomes of CKD (
end stage renal disease, cardiovascular event, and death) with respect to the underlying renal diseases.
Basic objectives2 Others
Basic objectives -Others Clinical outcome in prospective observation
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes End stage renal disease, Cardiovascular event, and Death
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Treated in nephrology outpatient clinic of center hospitals in Miyagi Prefecture.
Twenty years-old and over.The clinical finding is applecable to chronic kidney disease.
Informed and consent in writing about this study.
The medical record is available in essential data of baseline profile, laboratory finding, and treatment.
Key exclusion criteria Imcomplete baseline data.
Not agreed to inclusion
Target sample size 3000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mariko Miyazaki
Organization Tohoku University Hospital
Division name Department of Nephrology, Endocrinology and Vascular Medicine
Zip code
Address 1-1, Seiryo-machi, Aoba-ku, Sendai, JAPAN
TEL 022-717-7392
Email mamiyazaki-npr@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mariko Miyazaki
Organization Tohoku University Hospital
Division name Department of Nephrology, Endocrinology and Vascular Medicine
Zip code
Address 1-1, Seiryo-machi, Aoba-ku, Sendai. 980-8574, JAPAN
TEL 022-717-7392
Homepage URL
Email mamiyaza@med.tohoku.ac.jp

Sponsor
Institute Tohoku University Graduate School of Medicine, Department of Nephrology, Endocrinology and Vascular Medicine
Institute
Department

Funding Source
Organization Tohoku University Graduate School of Medicine, United Centers for Advanced Reserch and Translational Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Tohoku University Graduate School of Medicine, United Centers for Advanced Reserch and Translational Medicine, Center for Advanced Integrated Renal Science
Name of secondary funder(s) Ministry of Health, Labor and Welfare (JAPAN)
Miyagi Kidney Foundation
Astellas Pharma Inc.

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

Other administrative information
Date of disclosure of the study information
2013 Year 07 Month 18 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2006 Year 04 Month 17 Day
Date of IRB
Anticipated trial start date
2006 Year 05 Month 01 Day
Last follow-up date
2014 Year 02 Month 28 Day
Date of closure to data entry
2014 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information Annual observation is performed for 5 years from registration.

Management information
Registered date
2013 Year 07 Month 17 Day
Last modified on
2017 Year 07 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013135

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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