UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy and safety of sodium-glucose co-transporter (SGLT2) inhibitor in diabetic patients post renal transplantation
Title of the study (Brief title)	Efficacy and safety of sodium-glucose co-transporter (SGLT2) inhibitor in diabetic patients post renal transplantation
Region	Japan

Condition
Condition	Diabetic patients after kidney transplant
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to evaluate safety and efficacy of SGLT2 inhibitor for diabetic patients who have undergone kidney transplantation.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change in HbA1c (NGSP value), glycoalbumin, blood glucose before and after treatment
Key secondary outcomes	1. Change before and after treatment of the following items; Urinary protein, urinary albumin and renal function (estimated glomerular filtration rate; eGFR) 2. Safety Event of the following side effects; Low blood sugar Urinary Tract Infections and Genital Infections Diabetic ketoacidosis Renal dysfunction Liver dysfunction fracture Malignant tumor Cardiac and cerebrovascular events Skin symptoms

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	SGLT2 inhibitor is administered once a day for 6 months.
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	20 years-old <=
Age-upper limit	70 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Male and female aged 20 years or over, under 70 years old at the time of agreement acquisition 2. Patients diagnosed with diabetes 3. Patients who have undergone renal transplant 4. Patients with HbA1c (NGSP) of 6.0% or more and 9.0% or less Patients with Estimated Glomerular Filtration Rate (eGFR) of 30 mL / min / 1.73 m ^ 2 or more 5. Patients judged to have indications to use SGLT 2 inhibitors under normal medical treatment 6. Patients who have not used other SGLT2 inhibitors prior to the initiation of SGLT2 inhibitor prescription
Key exclusion criteria	1. Patients with a history of hypersensitivity to components of SGLT2 inhibitors 2. Type 1 diabetes 3. Patients with postoperative ureteral stenosis such as ureteral stent placement 4. Patients with a history of repeated pyelonephritis 5. Patients with severe ketosis or diabetic coma 6. Patients with severe infections, before and after surgery, severe trauma 7. Patients with end-stage renal failure who are undergoing hemodialysis or peritoneal dialysis 8. Pregnant women or patients with potential pregnancy 9. Patients who research managers judged inappropriate as subjects
Target sample size	15

Research contact person
Name of lead principal investigator	Tetsuya Babazono
Organization	Tokyo Women's Medical University School of Medicine
Division name	Diabetes Center
Address	8-1 Kawada-cho, Shinjuku, Tokyo 162-8666, Japan
TEL	03-3353-8111
Email	babazono.dmc@twmu.ac.jp

Public contact
Name of contact person	Nobue Tanaka
Organization	Tokyo Women's Medical University School of Medicine
Division name	Diabetes Center
Address	8-1 Kawada-cho, Shinjuku, Tokyo 162-8666, Japan
TEL	03-3353-8111
Homepage URL
Email	nobuetan.dmc@twmu.ac.jp

Sponsor
Institute	Tokyo Women's Medical University School of Medicine
Institute
Department

Funding Source
Organization	Tokyo Women's Medical University School of Medicine
Organization
Division
Category of Funding Organization	Other
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 08 Month 06 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 09 Month 27 Day
Anticipated trial start date	2018 Year 03 Month 01 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 08 Month 03 Day
Last modified on	2018 Year 08 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038344