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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000031454
Receipt No. 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

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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
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)

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
URL(English) https://upload.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


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