UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034387 |
|---|---|
| Receipt number | R000039202 |
| Scientific Title | Long-term renoprotective effect of SGLT2 inhibitors |
| Date of disclosure of the study information | 2018/11/01 |
| Last modified on | 2019/12/19 18:31:25 |
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Basic information
Public title
Long-term renoprotective effect of SGLT2 inhibitors
Acronym
Renoprotection by SGLT2 inhibitors
Scientific Title
Long-term renoprotective effect of SGLT2 inhibitors
Scientific Title:Acronym
Renoprotection by SGLT2 inhibitors
Region
| Japan |
Condition
Condition
type 2 diabetes melllitus
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the long-term renoprotective effect of SGLT2 inhibitors
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
decline rate of eGFR three years before and afater administration of SGLT2 inhibitors
Key secondary outcomes
clinical factors affecting decline rate of eGFR before and afater administration of SGLT2 inhibitors
quantitative changes of albuminuria and proteinuria
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
| 15 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The cases receiving SGLT2 inhibitors for 3 years or loger at JA Toride Medical Center
Key exclusion criteria
nothing particular
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Maeda |
Organization
JA Toride Medical Center
Division name
Nephrology
Zip code
302-0022
Address
2-1-1 Hongo, Toride, Ibaraki, Japan
TEL
81-297-74-5551
yoshimaeda43@toride-medical.or.jp
Public contact
Name of contact person
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Maeda |
Organization
JA Toride Medical Center
Division name
Nephrology
Zip code
302-0022
Address
2-1-1 Hongo, Toride, Ibaraki, Japan
TEL
81-297-74-5551
Homepage URL
yoshimaeda43@toride-medical.or.jp
Sponsor or person
Institute
Nephrology Division, JA Toride Medical Center
Institute
Department
Personal name
Funding Source
Organization
Nephrology Division, JA Toride Medical Center
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
Ethical Comitte of JA Toride Medical Center
Address
2-1-1 Hongo, Toride, Ibaraki, Japan
Tel
81-297-74-5551
toride@medical.email.ne.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
JAとりで総合医療センター（茨城県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 11 | Month | 01 | 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
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
Main results already published
Date of protocol fixation
| 2018 | Year | 10 | Month | 04 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 20 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2018 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 01 | Month | 01 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
patients in whom any of SGLT2 inhibitors has been prescribed since September 2015 or before until September 2018
Management information
Registered date
| 2018 | Year | 10 | Month | 05 | Day |
Last modified on
| 2019 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039202
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
