UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011211 |
|---|---|
| Receipt number | 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 20:28:05 |
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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
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
mamiyaza@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Graduate School of Medicine, Department of Nephrology, Endocrinology and Vascular Medicine
Institute
Department
Personal name
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
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
Value
https://center6.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 |
