Efficacy and Safety of Canagliflozin (TA-7284) in Patients With Diabetic Nephropathy

• Status: Completed
• Trial end date: 2021-01-21
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation
• Treatments: Canagliflozin

Criteria

Inclusion Criteria:

Additional criteria check may apply for qualification:

• Glycated hemoglobin(HbA1c) of ≥6.5% and ≤12.0%

• eGFR of ≥30 mL/min/1.73m2 and <90 mL/min/1.73m2

• The median UACR of the first morning void urine samples is ≥300 mg/g Cr and ≤5000 mg/g Cr

• Patients who are taking on angiotensin-converting enzyme inhibitor (ACE-I) or angiotensin receptor blocker (ARB)

• Patients who are under dietary management and taking therapeutic exercise for diabetes

Exclusion Criteria:

Additional criteria check may apply for qualification:

• Type I diabetes, diabetes mellitus resulting from pancreatic disorder, or secondary diabetes

• A diagnosis of non-diabetic renal disease

• Hereditary glucose-galactose malabsorption or primary renal glucosuria

• Class IV heart failure symptoms according to New York Heart Association (NYHA) functional classification

• Severe hepatic disorder or severe renal disorder

• Blood potassium level >5.5 mmoL/L

• Stable blood pressure (diastolic blood pressure (DBP) ≥180mmHg or systolic blood pressure (SBP) ≥100mmHg)