UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031454
Receipt number R000035910
Scientific Title Efficacy and safety of SGLT2 inhibitor in patients with diabetic kidney
Date of disclosure of the study information 2018/02/23
Last modified on 2018/02/23 19:56:39

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Basic information

Public title

Efficacy and safety of SGLT2 inhibitor in patients with diabetic kidney

Acronym

Efficacy and safety of SGLT2 inhibitor in DKD

Scientific Title

Efficacy and safety of SGLT2 inhibitor in patients with diabetic kidney

Scientific Title:Acronym

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

1st name
Middle name
Last name Masanori Abe

Organization

Nihon University Itabashi Hospital

Division name

Nephrology, Hypertension and Endocrinology

Zip code


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

1st name
Middle name
Last name Masanori Abe

Organization

Nihon University Itabashi Hospital

Division name

Nephrology, Hypertension and Endocrinology

Zip code


Address

30-1, Oyaguchi Kami-cho, Itabsahi-ku, Tokyo, Japan

TEL

03-3972-8311

Homepage URL


Email

abe.masanori@nihon-u.ac.jp


Sponsor or person

Institute

Nihon University

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


Related information

URL releasing protocol


Publication of results

Unpublished


Result

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



Progress

Recruitment status

Enrolling by invitation

Date of protocol fixation

2017 Year 01 Month 18 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035910


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name