UMIN-CTR Clinical Trial

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

Diabetes mellitus with/without neprhopathy

Classification by specialty

Medicine in general	Endocrinology and Metabolism	Nephrology

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

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

Institute

Department

Personal name

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

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）

Date of disclosure of the study information

2016

Year

06

Month

04

Day

URL releasing protocol

Publication of results

Partially published

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

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 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.

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