UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031821
Receipt number R000036338
Scientific Title Study on proper use of the incretin related drugs and effects on renal function.
Date of disclosure of the study information 2018/03/20
Last modified on 2021/09/21 12:42:47

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Basic information

Public title

Study on proper use of the incretin related drugs and effects on renal function.

Acronym

Super REAL

Scientific Title

Study on proper use of the incretin related drugs and effects on renal function.

Scientific Title:Acronym

Super REAL

Region

Japan


Condition

Condition

type 2 diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We clarify whether the use of incretin related drugs for diabetic patients is properly used based on renal function. In addition, we study the effects on clinical parameters, especially kidney function.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

eGFR change

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

Type 2 diabetes patients who used incretin related drugs in our hospital from 1st December 2009 to 31st May 2017.

Key exclusion criteria

Cases in which the test results were lost due to the transfer.

Target sample size

2000


Research contact person

Name of lead principal investigator

1st name Masao
Middle name
Last name Toyoda

Organization

Tokai University School of Medicine

Division name

Division of Nephrology, Endocrinology and Metabolism

Zip code

259-1193

Address

143 Shimokasuya, Isehara, Kanagawa 2 59-1193, JAPAN

TEL

0463-93-1121

Email

m-toyoda@is.icc.u-tokai.ac.jp


Public contact

Name of contact person

1st name Kanori
Middle name
Last name Iwamatsu

Organization

Tokai University School of Medicine

Division name

Division of Nephrology, Endocrinology and Metabolism

Zip code

259-1193

Address

143 Shimokasuya, Isehara, Kanagawa 2 59-1193, JAPAN

TEL

0463-93-1121

Homepage URL


Email

k-iwamtsu@tsc.u-tokai.ac.jp


Sponsor or person

Institute

Division of Nephrology, Endocrinology and Metabolism, Tokai University Scho ol of Medicine

Institute

Department

Personal name



Funding Source

Organization

Division of Nephrology, Endocrinology and Metabolism, Tokai University Scho ol of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Institutional review board for clinical research, Tokai University

Address

143 Shimokasuya, Isehara, Kanagawa 2 59-1193, JAPAN

Tel

0463-93-1121

Email

tokai-rinsho@ml.tokai-u.jp


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

2018 Year 03 Month 20 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled

200

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

2017 Year 11 Month 02 Day

Date of IRB

2017 Year 09 Month 06 Day

Anticipated trial start date

2017 Year 11 Month 02 Day

Last follow-up date

2019 Year 12 Month 31 Day

Date of closure to data entry

2020 Year 12 Month 31 Day

Date trial data considered complete

2020 Year 12 Month 31 Day

Date analysis concluded

2021 Year 12 Month 31 Day


Other

Other related information

No intervention, retrospective observation study.


Management information

Registered date

2018 Year 03 Month 20 Day

Last modified on

2021 Year 09 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036338


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name