- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03436693
Efficacy and Safety of Canagliflozin (TA-7284) in Patients With Diabetic Nephropathy
September 2, 2021 updated by: Mitsubishi Tanabe Pharma Corporation
A Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy and Safety of Canagliflozin (TA-7284) in Patients With Diabetic Nephropathy
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
308
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Aichi, Japan
- Research Site
-
Chiba, Japan
- Research Site
-
Fukuoka, Japan
- Research Site
-
Fukushima, Japan
- Research Site
-
Gunma, Japan
- Research Site
-
Hiroshima, Japan
- Research Site
-
Hokkaido, Japan
- Research Site
-
Hyogo, Japan
- Research Site
-
Ibaraki, Japan
- Research Site
-
Kagawa, Japan
- Research Site
-
Kagoshima, Japan
- Research Site
-
Kanagawa, Japan
- Research Site
-
Kumamoto, Japan
- Research Site
-
Mie, Japan
- Research Site
-
Nagano, Japan
- Research Site
-
Nagasaki, Japan
- Research Site
-
Oita, Japan
- Research Site
-
Okinawa, Japan
- Research Site
-
Osaka, Japan
- Research Site
-
Saitama, Japan
- Research Site
-
Shizuoka, Japan
- Research Site
-
Tochigi, Japan
- Research Site
-
Tokyo, Japan
- Research Site
-
Wakayama, Japan
- Research Site
-
Yamagata, Japan
- Research Site
-
Yamaguchi, Japan
- Research Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
Placebo orally once daily
|
Experimental: Canagliflozin 100mg
|
Canagliflozin 100mg orally once daily
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The proportion of subjects with a decline in estimated glomerular filtration rate (eGFR) from baseline at Week 104
Time Frame: Baseline and Week 104
|
Baseline and Week 104
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline in eGFR at each assessment time point
Time Frame: Baseline to Week 104
|
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
Time Frame: up to approximately 104 weeks
|
up to approximately 104 weeks
|
Change from baseline in urine albumin-to-creatinine ratio (UACR) at each assessment time point
Time Frame: Baseline to Week 104
|
Baseline to Week 104
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 15, 2018
Primary Completion (Actual)
January 21, 2021
Study Completion (Actual)
January 21, 2021
Study Registration Dates
First Submitted
February 1, 2018
First Submitted That Met QC Criteria
February 12, 2018
First Posted (Actual)
February 19, 2018
Study Record Updates
Last Update Posted (Actual)
September 5, 2021
Last Update Submitted That Met QC Criteria
September 2, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TA-7284-14
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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