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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000022602
Receipt No. 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

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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
Email 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
Email masa-miu@hyo-med.ac.jp

Sponsor
Institute Division of Diabetes, Endocrinology and Metabolism, Department of Internal Medicine, Hyogo College of Medicine
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026054

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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