UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000035278
Receipt No. 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 (Ver. 4)

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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
Email 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
Email seigosugiyama@jinnouchi.or.jp

Sponsor
Institute Jinnouchi Hospital
Diabetes Care Center
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040193