UMIN-CTR Clinical Trial

Public title

Efficacy and safety of sodium-glucose co-transporter (SGLT2) inhibitor in diabetic patients post renal transplantation

Acronym

Efficacy and safety of sodium-glucose co-transporter (SGLT2) inhibitor in diabetic patients post renal transplantation

Scientific Title

Efficacy and safety of sodium-glucose co-transporter (SGLT2) inhibitor in diabetic patients post renal transplantation

Scientific Title:Acronym

Efficacy and safety of sodium-glucose co-transporter (SGLT2) inhibitor in diabetic patients post renal transplantation

Region

Japan

Condition

Diabetic patients after kidney transplant

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Tetsuya Babazono

Organization

Tokyo Women's Medical University School of Medicine

Division name

Diabetes Center

Zip code

Address

8-1 Kawada-cho, Shinjuku, Tokyo 162-8666, Japan

TEL

03-3353-8111

Email

babazono.dmc@twmu.ac.jp

Name of contact person

1st name
Middle name
Last name	Nobue Tanaka

Organization

Tokyo Women's Medical University School of Medicine

Division name

Diabetes Center

Zip code

Address

8-1 Kawada-cho, Shinjuku, Tokyo 162-8666, Japan

TEL

03-3353-8111

Homepage URL

Email

nobuetan.dmc@twmu.ac.jp

Institute

Tokyo Women's Medical University School of Medicine

Institute

Department

Personal name

Organization

Tokyo Women's Medical University School of Medicine

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2018

Year

08

Month

06

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

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

Recruitment status

Open public recruiting

Date of protocol fixation

2017

Year

09

Month

27

Day

Date of IRB

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

Other related information

Registered date

2018

Year

08

Month

03

Day

Last modified on

2018

Year

08

Month

03

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038344