UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective survey of the patient characteristics and outcomes for outpatient nephrology clinics in Miyagi Prefecture
Title of the study (Brief title)	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	Mariko Miyazaki
Organization	Tohoku University Hospital
Division name	Department of Nephrology, Endocrinology and Vascular Medicine
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	Mariko Miyazaki
Organization	Tohoku University Hospital
Division name	Department of Nephrology, Endocrinology and Vascular Medicine
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.

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2006 Year 04 Month 17 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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