The purpose of this study is to evaluate the efficacy and safety of Canagliflozin (TA-7284) in Japanese patients with Diabetic Nephropathy, compared with placebo
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
308
Canagliflozin 100mg orally once daily
Placebo orally once daily
Research site
Aichi, Japan
Research site
Chiba, Japan
Percentage of Participants With 30% Decline in Estimated Glomerular Filtration Rate (eGFR) From Baseline at Week 104
Percentage of participants with 30% decline in eGFR was calculated by multiple imputation method for missing data.
Time frame: Week 104
Percentage of Participants With 40% Decline in eGFR From Baseline at Week 104
Percentage of participants with 40% decline in eGFR was calculated by multiple imputation method for missing data.
Time frame: Week 104
Change From Baseline in eGFR at Week 104
Time frame: Baseline and Week 104
Composite Endpoint of End-stage Renal Disease (ESRD), Doubling of Serum Creatinine, Renal Death, and Cardiovascular (CV) Death
Time frame: up to approximately 108 weeks
Change From Baseline in Percentage of Urine Albumin-to -Creatinine Ratio (UACR) at Week 104
Time frame: Baseline and Week 104
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Research site
Fukuoka, Japan
Research site
Fukushima, Japan
Research site
Gunma, Japan
Research site
Hiroshima, Japan
Research site
Hokkaido, Japan
Research site
Hyōgo, Japan
Research site
Ibaraki, Japan
Research site
Kagawa, Japan
...and 16 more locations