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

Primary Purpose

Diabetic Nephropathy

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Canagliflozin
Placebo
Sponsored by
Mitsubishi Tanabe Pharma Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Nephropathy focused on measuring Diabetic Nephropathy, Canagliflozin, Canaglu, Diabetes Mellitus, Type 2

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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) ≥180mmHg or systolic blood pressure (SBP) ≥100mmHg)

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Canagliflozin 100mg

Placebo

Arm Description

Outcomes

Primary Outcome Measures

The proportion of subjects with a decline in estimated glomerular filtration rate (eGFR) from baseline at Week 104

Secondary Outcome Measures

Change from baseline in eGFR at each assessment time point
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
Change from baseline in urine albumin-to-creatinine ratio (UACR) at each assessment time point

Full Information

First Posted
February 1, 2018
Last Updated
September 2, 2021
Sponsor
Mitsubishi Tanabe Pharma Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT03436693
Brief Title
Efficacy and Safety of Canagliflozin (TA-7284) in Patients With Diabetic Nephropathy
Official Title
A Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy and Safety of Canagliflozin (TA-7284) in Patients With Diabetic Nephropathy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
February 15, 2018 (Actual)
Primary Completion Date
January 21, 2021 (Actual)
Study Completion Date
January 21, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mitsubishi Tanabe Pharma Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Nephropathy
Keywords
Diabetic Nephropathy, Canagliflozin, Canaglu, Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
308 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Canagliflozin 100mg
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Canagliflozin
Other Intervention Name(s)
TA-7284, Canaglu
Intervention Description
Canagliflozin 100mg orally once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo orally once daily
Primary Outcome Measure Information:
Title
The proportion of subjects with a decline in estimated glomerular filtration rate (eGFR) from baseline at Week 104
Time Frame
Baseline and Week 104
Secondary Outcome Measure Information:
Title
Change from baseline in eGFR at each assessment time point
Time Frame
Baseline to Week 104
Title
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
Time Frame
up to approximately 104 weeks
Title
Change from baseline in urine albumin-to-creatinine ratio (UACR) at each assessment time point
Time Frame
Baseline to Week 104

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
General Manager
Organizational Affiliation
Mitsubishi Tanabe Pharma Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Research site
City
Aichi
Country
Japan
Facility Name
Research site
City
Chiba
Country
Japan
Facility Name
Research site
City
Fukuoka
Country
Japan
Facility Name
Research site
City
Fukushima
Country
Japan
Facility Name
Research site
City
Gunma
Country
Japan
Facility Name
Research site
City
Hiroshima
Country
Japan
Facility Name
Research site
City
Hokkaido
Country
Japan
Facility Name
Research site
City
Hyogo
Country
Japan
Facility Name
Research site
City
Ibaraki
Country
Japan
Facility Name
Research site
City
Kagawa
Country
Japan
Facility Name
Research site
City
Kagoshima
Country
Japan
Facility Name
Research site
City
Kanagawa
Country
Japan
Facility Name
Research site
City
Kumamoto
Country
Japan
Facility Name
Research site
City
Mie
Country
Japan
Facility Name
Research site
City
Nagano
Country
Japan
Facility Name
Research site
City
Nagasaki
Country
Japan
Facility Name
Research site
City
Oita
Country
Japan
Facility Name
Research site
City
Okinawa
Country
Japan
Facility Name
Research site
City
Osaka
Country
Japan
Facility Name
Research site
City
Saitama
Country
Japan
Facility Name
Research site
City
Shizuoka
Country
Japan
Facility Name
Research site
City
Tochigi
Country
Japan
Facility Name
Research site
City
Tokyo
Country
Japan
Facility Name
Research site
City
Wakayama
Country
Japan
Facility Name
Research site
City
Yamagata
Country
Japan
Facility Name
Research site
City
Yamaguchi
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

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

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