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

Tanabe Pharma Corporation

Status and phase: Completed; Phase 3

Conditions: Diabetic Nephropathy

Treatments: Drug: Placebo; Drug: Canagliflozin

Study type: Interventional

Funder types: Industry

Identifiers

NCT03436693

TA-7284-14

Details and patient eligibility

About

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

Enrollment: 308 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

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) ≥100mmHg or systolic blood pressure (SBP) ≥180mmHg)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

308 participants in 2 patient groups, including a placebo group

Canagliflozin 100mg

Experimental group

Treatment:

Drug: Canagliflozin

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo