UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy and safety of SGLT2 inhibitor in patients with diabetic kidney
Title of the study (Brief title)	Efficacy and safety of SGLT2 inhibitor in DKD
Region	Japan

Condition
Condition	Diabetic nephropathy
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To identify the efficacy and safety of SGLT2 inhibitor in patients with diabetic nephropathy
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes in albuminuria and hemoglobin
Key secondary outcomes	Urinary L-FABP, NAG, Beta2-microglobulin, eGFR, and safety

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification	NO
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	SGLT2 inhibitor
Interventions/Control_2	Standard care
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	20 years-old <=
Age-upper limit	85 years-old >=
Gender	Male and Female
Key inclusion criteria	1. type 2 diabetes with nephropathy under stable glycemic control, defined as a HbA1c level <10.0% after administration of oral anti-diabetic agents or insulin injection therapy for 8 consecutive weeks; 2) albuminuria: urinary albumin to creatinine (Cr) ratio (UACR) 30 to 2000 mg/g (average of two consecutive measurements recorded during the 8-week pre-treatment period); 3) estimated glomerular filtration rate (eGFR) of 45-89 mL/min/1.73 m2; and 4) hypertension who were treated with a fixed dose of RAS inhibitors for at least 8 weeks before the study.
Key exclusion criteria	1) age <20 years or >85 years; 2) eGFR >90 mL/min/1.73 m2 or <45 mL/min/1.73 m2; 3) HbA1c >10.0%; 4) severe heart failure, angina, myocardial infarction, or stroke occurring within 6 months before the trial; and 5) previous treatment with SGLT2 inhibitors for at least 8 weeks before the study.
Target sample size	40

Research contact person
Name of lead principal investigator	Masanori Abe
Organization	Nihon University Itabashi Hospital
Division name	Nephrology, Hypertension and Endocrinology
Address	30-1, Oyaguchi Kami-cho, Itabsahi-ku, Tokyo, Japan
TEL	03-3972-8311
Email	abe.masanori@nihon-u.ac.jp

Public contact
Name of contact person	Masanori Abe
Organization	Nihon University Itabashi Hospital
Division name	Nephrology, Hypertension and Endocrinology
Address	30-1, Oyaguchi Kami-cho, Itabsahi-ku, Tokyo, Japan
TEL	03-3972-8311
Homepage URL
Email	abe.masanori@nihon-u.ac.jp

Sponsor
Institute	Nihon University
Institute
Department

Funding Source
Organization	Nihon University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2018 Year 02 Month 23 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2017 Year 01 Month 18 Day
Anticipated trial start date	2017 Year 01 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 02 Month 23 Day
Last modified on	2018 Year 02 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035910