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

Study Overview
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Brief Summary
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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

Official Title
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A Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy and Safety of Canagliflozin (TA-7284) in Patients With Diabetic Nephropathy

Conditions
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Diabetic Nephropathy

Intervention / Treatment
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* Drug: Canagliflozin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Canagliflozin 100mg<br> | Drug: Canagliflozin<br>* Canagliflozin 100mg orally once daily<br>* Other names: TA-7284, Canaglu;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo orally once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of subjects with a decline in estimated glomerular filtration rate (eGFR) from baseline at Week 104 |  | Baseline and Week 104 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in eGFR at each assessment time point |  | Baseline to Week 104 | 
| Time to the first occurrence of an event in the composite endpoint: end-stage renal disease (ESRD), doubling of serum creatinine, renal death, or cardiovascular (CV) death |  | up to approximately 104 weeks | 
| Change from baseline in urine albumin-to-creatinine ratio (UACR) at each assessment time point |  | Baseline to Week 104 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetic Nephropathy, Canagliflozin, Canaglu, Diabetes Mellitus, Type 2