UMIN-CTR Clinical Trial

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
Email	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
Email	kiyopon19840330@yahoo.co.jp

Sponsor
Institute	Obihiro-Kosei General Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000045887