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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

308 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-15

Study Completion Date

2021-01-21

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

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Detailed Description

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Conditions

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Diabetic Nephropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Canagliflozin 100mg

Group Type EXPERIMENTAL

Canagliflozin

Intervention Type DRUG

Canagliflozin 100mg orally once daily

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo orally once daily

Interventions

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Canagliflozin

Canagliflozin 100mg orally once daily

Intervention Type DRUG

Placebo

Placebo orally once daily

Intervention Type DRUG

Other Intervention Names

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TA-7284, Canaglu

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

Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No