UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035278 |
|---|---|
| Receipt number | R000040193 |
| Scientific Title | A retrospective study: Effects of additional SGLT2-inhibitor therapy on renal functions in patients with type 2 diabetes mellitus and stage 3b and 4 chronic kidney disease |
| Date of disclosure of the study information | 2018/12/18 |
| Last modified on | 2019/06/19 09:38:06 |
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Basic information
Public title
A retrospective study: Effects of additional SGLT2-inhibitor therapy on renal functions in patients with type 2 diabetes mellitus and stage 3b and 4 chronic kidney disease
Acronym
Renal benefits of SGLT2-inhibitors in advanced CKD
Scientific Title
A retrospective study: Effects of additional SGLT2-inhibitor therapy on renal functions in patients with type 2 diabetes mellitus and stage 3b and 4 chronic kidney disease
Scientific Title:Acronym
Renal benefits of SGLT2-inhibitors in advanced CKD
Region
| Japan |
Condition
Condition
type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigated the annual changes in eGFR before and after the SGLT2-inhibitor therapy in patients suffered from moderate-to-severe renal impairment as CKD stages 3b-4 (15< eGFR <45 ml/min/1.73m2) at beginning SGTL2-inhibitor treatment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
improvement of annual changes in eGFR
Key secondary outcomes
improvement of urinary protein
decrease in HbA1c
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
type 2 diabetes
more than one year treatment history of SGLT2-inhibitors
impaired renal function (15<eGFR<45) at beginning SGLT2-inhibitor therapy
Key exclusion criteria
type 1 DM
cancer
auto-immune disease
active inflammation
dimentia
Target sample size
22
Research contact person
Name of lead principal investigator
| 1st name | Seigo |
| Middle name | |
| Last name | Sugiyama |
Organization
Jinnouchi Hospital
Division name
Diabetes Care Center
Zip code
862-0976
Address
6-2-3 Kuhonji Chuo-ku Kumamoto-city Kumamoto Japan
TEL
096-363-0011
seigosugiyama@jinnouchi.or.jp
Public contact
Name of contact person
| 1st name | Seigo |
| Middle name | |
| Last name | Sugiyama |
Organization
Jinnouchi Hospital
Division name
Diabetes Care Center
Zip code
862-0976
Address
6-2-3 Kuhonji Chuo-ku Kumamoto-city Kumamoto Japan
TEL
096-363-0011
Homepage URL
seigosugiyama@jinnouchi.or.jp
Sponsor or person
Institute
Jinnouchi Hospital
Diabetes Care Center
Institute
Department
Personal name
Funding Source
Organization
Jinnouchi Hospital
Diabetes Care 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
Jinnouchi Hospital
Address
6-2-3 Kuhonji Chuo-ku Kumamoto-city Kumamoto Japan
Tel
096-363-0011
hisyo@jinnouchi.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
陣内病院
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 12 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
doi: https://doi.org/10.14740/jocmr3761
Number of participants that the trial has enrolled
42
Results
We analyzed 42 T2DM patients with median GFR of 40.4 mL/min/1.73 m2. The annual decline in eGFR improved significantly after SGLT2 inhibitor therapy (eGFR: (median), pre: -3.8, vs. post: 0.1 mL/min/1.73 m2 per year, P < 0.01). We also found a significant decrease in urinary protein excretion after SGLT2 inhibitor therapy (urinary protein-to-creatinine ratio: (median), pre: 0.36, vs. post: 0.23 g/g creatinine, n = 35, P < 0.01).
Results date posted
| 2019 | Year | 06 | Month | 19 | Day |
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
Completed
Date of protocol fixation
| 2018 | Year | 03 | Month | 30 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 25 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The results will be presented at the Japan Diabetes Society Annual meeting 2019.
Management information
Registered date
| 2018 | Year | 12 | Month | 17 | Day |
Last modified on
| 2019 | Year | 06 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040193
