UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022602 |
|---|---|
| Receipt number | R000026054 |
| Scientific Title | Pursuance of Retrospective eGFR study for Strategic Trial for the Prevention of Progression of Overt Diabetic Nephropathy |
| Date of disclosure of the study information | 2016/06/04 |
| Last modified on | 2018/12/06 16:37:14 |
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Basic information
Public title
Pursuance of Retrospective eGFR study for Strategic Trial for the Prevention of Progression of Overt Diabetic Nephropathy
Acronym
PRe-STOPPER study
Scientific Title
Pursuance of Retrospective eGFR study for Strategic Trial for the Prevention of Progression of Overt Diabetic Nephropathy
Scientific Title:Acronym
PRe-STOPPER study
Region
| Japan |
Condition
Condition
Diabetes mellitus with/without neprhopathy
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It is unknown how kidney function was being deteriorated in diabetic subjects, particularly in diabetic nephropathy. We recruited delta-eGFRslope0-1y as the marker of change of eGFR during a year, and clarify how it changes at the several stage of kidney function.
Basic objectives2
Others
Basic objectives -Others
This study is a retrospective observation study. We use the clinical data during a year, and clarify how kidney function was being deteriorated. Additionally, we analyze the other clinical factor during a year and clarify whether those data have any relation to the change of kidney function.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
delta-eGFRslope0-1y during a year from the clinical data
Key secondary outcomes
Clinical data: HbA1c, UACR, UPCR, LDL-C, HDL-C, TG, sBP, dBP.
Medications: for diabetes mellitus, hypertension and dyslipidemia.
Certified diabetic education.
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
Diabetic subjects who were cared and treated during a year in several medical center.
Key exclusion criteria
Less than 20 years old.
Target sample size
10000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masayuki Miuchi |
Organization
Hyogo College of Medicine
Division name
Division of Diabetes, Endocrinology and Metabolism, Department of Internal Medicine
Zip code
Address
1-1 Mukogawa, Nishinomiya, Hyogo, Japan
TEL
0798-45-6592
masa-miu@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masayuki Miuchi |
Organization
Hyogo College of Medicine
Division name
Division of Diabetes, Endocrinology and Metabolism, Department of Internal Medicine
Zip code
Address
1-1 Mukogawa, Nishinomiya, Hyogo, Japan
TEL
0798-45-6592
Homepage URL
http://jmap.or.jp
masa-miu@hyo-med.ac.jp
Sponsor or person
Institute
Division of Diabetes, Endocrinology and Metabolism, Department of Internal Medicine, Hyogo College of Medicine
Institute
Department
Personal name
Funding Source
Organization
Division of Diabetes, Endocrinology and Metabolism, Department of Internal Medicine, Hyogo College of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
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
兵庫医科大学（兵庫県）、函館稜北病院（北海道）、大館市立総合病院（秋田）、千葉県循環器病センター（千葉）、総合病院 国保旭中央病院（千葉）、皆野病院（埼玉）、獨協医科大学 日光医療センター（栃木）、佐久市立国保浅間総合病院（長野）、やわたメディカルセンター（石川）、伊勢赤十字病院（三重）、入江病院（兵庫）、徳島県立中央病院（徳島）、市立八幡浜総合病院（愛媛）、佐賀大学（佐賀）、唐津赤十字病院（佐賀）、臼杵市医師会立コスモス病院（大分）、国東市民病院（大分）、すながわ内科クリニック（沖縄）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 06 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
http://jmap.or.jp
Number of participants that the trial has enrolled
Results
We clarified the difference of delta-eGFR during a year at the several stage of kidney function in diabetic subjects with nephropathy, from the interim report of Pre-STOPPER study. Delta-eGFR during a year was dramatically dropped worse around the area of kidney failure. Additionally, incremental HbA1c was much related to the deterioration of delta-eGFR during a year.
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
| 2015 | Year | 06 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 06 | Month | 10 | Day |
Last follow-up date
| 2015 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2017 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 28 | Day |
Other
Other related information
We then investigate that delta-eGFR during a year has any relation with the other clinical data, medications and certified diabetes education.
The data of the interim report of "PRe-STOPPER" study was presented in the annual meeting of European Association for the Study of Diabetes (EASD) 2016 at Munich, Germany. Both of average HbA1c and its %CV were significantly higher in the patients whose eGFR was rapidly declined. It is important to control the glucose level intensively.
Management information
Registered date
| 2016 | Year | 06 | Month | 04 | Day |
Last modified on
| 2018 | Year | 12 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026054
