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
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
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
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
