Status:
COMPLETED
Efficacy and Safety of Canagliflozin (TA-7284) in Patients With Diabetic Nephropathy
Lead Sponsor:
Tanabe Pharma Corporation
Conditions:
Diabetic Nephropathy
Eligibility:
All Genders
30+ years
Phase:
PHASE3
Brief 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
Eligibility Criteria
Inclusion
- 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
- 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) ≥100mmHg or systolic blood pressure (SBP) ≥180mmHg)
Key Trial Info
Start Date :
February 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 21 2021
Estimated Enrollment :
308 Patients enrolled
Trial Details
Trial ID
NCT03436693
Start Date
February 15 2018
End Date
January 21 2021
Last Update
January 7 2026
Active Locations (26)
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1
Research site
Aichi, Japan
2
Research site
Chiba, Japan
3
Research site
Fukuoka, Japan
4
Research site
Fukushima, Japan