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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033628
Receipt No. R000038344
Official scientific title of the study Efficacy and safety of sodium-glucose co-transporter (SGLT2) inhibitor in diabetic patients post renal transplantation
Date of disclosure of the study information 2018/08/06
Last modified on 2018/08/03

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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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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