Efficacy and Safety of Canagliflozin (TA-7284) in Patients With Diabetic Nephropathy
A Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy and Safety of Canagliflozin (TA-7284) in Patients With Diabetic Nephropathy
1 other identifier
interventional
308
1 country
26
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Feb 2018
Typical duration for phase_3
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 1, 2018
CompletedStudy Start
First participant enrolled
February 15, 2018
CompletedFirst Posted
Study publicly available on registry
February 19, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 21, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 21, 2021
CompletedResults Posted
Study results publicly available
July 15, 2024
CompletedJanuary 7, 2026
December 1, 2025
2.9 years
February 1, 2018
March 30, 2023
December 15, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With 30% Decline in Estimated Glomerular Filtration Rate (eGFR) From Baseline at Week 104
Percentage of participants with 30% decline in eGFR was calculated by multiple imputation method for missing data.
Week 104
Secondary Outcomes (4)
Percentage of Participants With 40% Decline in eGFR From Baseline at Week 104
Week 104
Change From Baseline in eGFR at Week 104
Baseline and Week 104
Composite Endpoint of End-stage Renal Disease (ESRD), Doubling of Serum Creatinine, Renal Death, and Cardiovascular (CV) Death
up to approximately 108 weeks
Change From Baseline in Percentage of Urine Albumin-to -Creatinine Ratio (UACR) at Week 104
Baseline and Week 104
Study Arms (2)
Canagliflozin 100mg
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Canagliflozin 100mg orally once daily
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
Research site
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
Hyōgo, 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
Okinawa, Japan
Research site
Osaka, Japan
Research site
Ōita, 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
Related Publications (2)
Wada T, Mori-Anai K, Takahashi A, Matsui T, Inagaki M, Iida M, Maruyama K, Tsuda H. Effect of canagliflozin on the decline of estimated glomerular filtration rate in chronic kidney disease patients with type 2 diabetes mellitus: A multicenter, randomized, double-blind, placebo-controlled, parallel-group, phase III study in Japan. J Diabetes Investig. 2022 Dec;13(12):1981-1989. doi: 10.1111/jdi.13888. Epub 2022 Aug 9.
PMID: 35861630RESULTNatale P, Tunnicliffe DJ, Toyama T, Palmer SC, Saglimbene VM, Ruospo M, Gargano L, Stallone G, Gesualdo L, Strippoli GF. Sodium-glucose co-transporter protein 2 (SGLT2) inhibitors for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 May 21;5(5):CD015588. doi: 10.1002/14651858.CD015588.pub2.
PMID: 38770818DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Trials, Information Desk
- Organization
- Tanabe Pharma Corporation
Study Officials
- STUDY DIRECTOR
General Manager
Tanabe Pharma Corporation
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 1, 2018
First Posted
February 19, 2018
Study Start
February 15, 2018
Primary Completion
January 21, 2021
Study Completion
January 21, 2021
Last Updated
January 7, 2026
Results First Posted
July 15, 2024
Record last verified: 2025-12