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
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
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
- Research site
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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
NCT ID
NCT03436693
First Posted
February 1, 2018
Last Updated
September 2, 2021
Sponsor
Mitsubishi Tanabe Pharma Corporation
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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