UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040424 |
|---|---|
| Receipt number | R000045887 |
| Scientific Title | Renal protective effect after administration of sodium-glucose cotransporter 2 inhibitors in type 2 diabetes patients and chronic kidney disease with normoalbuminuria |
| Date of disclosure of the study information | 2020/05/19 |
| Last modified on | 2021/11/17 12:16:34 |
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Basic information
Public title
Renal protective effect after administration of sodium-glucose cotransporter 2 inhibitors in type 2 diabetes patients and chronic kidney disease with normoalbuminuria
Acronym
Renal protective effect after administration of SGLT2 inhibitors in atypical DKD
Scientific Title
Renal protective effect after administration of sodium-glucose cotransporter 2 inhibitors in type 2 diabetes patients and chronic kidney disease with normoalbuminuria
Scientific Title:Acronym
Renal protective effect after administration of SGLT2 inhibitors in atypical DKD
Region
| Japan |
Condition
Condition
type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the renoprotective effects of SGLT2 inhibitor for with type 2 diabetes and CKD with normoalbuminuria
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
to assess the clinical effectiveness of SGLT2is on renal function by analyzing the change in eGFR at 1 years after initiating SGLT2 inhibitor compare with that in conventional antidiabetic medication
Key secondary outcomes
to investigate the variables associated with the change in eGFR at 1 years after initiating SGLT2 inhibitor
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with type 2 diabetes and CKD (eGFR < 60 mL/min/1.73 m2) with normoalbuminurea (urine albumin to creatinine ratio (UACR) < 30 mg/g Cr and/or urinary protein to creatinine ratio (UPCR) < 150 mg/g Cr)
Key exclusion criteria
1)type 1 diabetes
2)taking glucagon-like peptide-1 receptor agonists for type 2 diabetes
3)endocrine disease
4)taking steroid or immunosuppressant for autoimmune disease
5)dialysis, transplantation
6)liver cirrhosis and malignancy
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kiyohiko |
| Middle name | |
| Last name | Takahashi |
Organization
Obihiro-Kosei General Hospital
Division name
Third Department of Internal Medicine
Zip code
080-0024
Address
1,W14,S10,Obihiro, Hokkaido
TEL
0155-65-0101
kiyopon19840330@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Kiyohiko |
| Middle name | |
| Last name | Takahashi |
Organization
Obihiro-Kosei General Hospital
Division name
Third Department of Internal Medicine
Zip code
080-0024
Address
1,W14,S10,Obihiro, Hokkaido
TEL
0155-65-0101
Homepage URL
kiyopon19840330@yahoo.co.jp
Sponsor or person
Institute
Obihiro-Kosei General Hospital
Institute
Department
Personal name
Funding Source
Organization
Obihiro-Kosei General Hospital
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
Obihiro-Kosei General Hospital
Address
1,W14,S10,Obihiro, Hokkaido
Tel
0155-65-0101
obi.rinris@ja-hokkaidoukouseiren.or.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
| 2020 | Year | 05 | Month | 19 | Day |
Related information
URL releasing protocol
https://www.dou-kouseiren.com/byouin/obihiro/about/rinri/oputouteord/2020017.pdf
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1016/j.jcte.2020.100244
Number of participants that the trial has enrolled
46
Results
21 were treated with SGLT2 group and 25 were treated with other antidiabetic medications control group. Although eGFR was significantly decreased at 1 year in the control group, the decline in eGFR was not observed in the SGLT2 group. The decrease in eGFR was significantly smaller in the SGLT2 group than in the control group. Additionally, multiple linear regression analysis showed that an initial dip was an independent factor associated with the worsening of renal function in the SGLT2 group.
Results date posted
| 2021 | Year | 11 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
SGLT2 group G3a: 15, G3b: 5, and G4: 1; control group G3a: 18, G3b: 5, and G4: 2
Participant flow
The study was conducted with the approval of the Institutional Review Board of Obihiro Kosei Hospital (2020-017),
Adverse events
nothing
Outcome measures
The study outcome was a comparison of the change in renal function evaluated by eGFR after 1 year between the two groups.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 11 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 11 | Day |
Last follow-up date
| 2020 | Year | 05 | Month | 11 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Renal protective effect after administration of sodium-glucose cotransporter 2 inhibitors in type 2 diabetes patients and chronic kidney disease with normoalbuminuria
Management information
Registered date
| 2020 | Year | 05 | Month | 17 | Day |
Last modified on
| 2021 | Year | 11 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045887
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