Unique ID issued by UMIN | UMIN000031454 |
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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 |
Efficacy and safety of SGLT2 inhibitor in patients with diabetic kidney
Efficacy and safety of SGLT2 inhibitor in DKD
Efficacy and safety of SGLT2 inhibitor in patients with diabetic kidney
Efficacy and safety of SGLT2 inhibitor in DKD
Japan |
Diabetic nephropathy
Nephrology |
Others
NO
To identify the efficacy and safety of SGLT2 inhibitor in patients with diabetic nephropathy
Safety,Efficacy
Changes in albuminuria and hemoglobin
Urinary L-FABP, NAG, Beta2-microglobulin, eGFR, and safety
Interventional
Parallel
Randomized
Cluster
Open -but assessor(s) are blinded
Active
NO
YES
Institution is not considered as adjustment factor.
NO
2
Treatment
Medicine |
SGLT2 inhibitor
Standard care
20 | years-old | <= |
85 | years-old | >= |
Male and Female
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.
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.
40
1st name | |
Middle name | |
Last name | Masanori Abe |
Nihon University Itabashi Hospital
Nephrology, Hypertension and Endocrinology
30-1, Oyaguchi Kami-cho, Itabsahi-ku, Tokyo, Japan
03-3972-8311
abe.masanori@nihon-u.ac.jp
1st name | |
Middle name | |
Last name | Masanori Abe |
Nihon University Itabashi Hospital
Nephrology, Hypertension and Endocrinology
30-1, Oyaguchi Kami-cho, Itabsahi-ku, Tokyo, Japan
03-3972-8311
abe.masanori@nihon-u.ac.jp
Nihon University
Nihon University
Self funding
NO
2018 | Year | 02 | Month | 23 | Day |
Unpublished
Enrolling by invitation
2017 | Year | 01 | Month | 18 | Day |
2017 | Year | 01 | Month | 20 | Day |
2018 | Year | 02 | Month | 23 | Day |
2018 | Year | 02 | Month | 23 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035910
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