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

December 15, 2025 updated by: 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

  • Japan
      • 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
      • 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
      • Ōita, 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

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

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
Drug: Placebo
Placebo orally once daily
Experimental: Canagliflozin 100mg
Drug: Canagliflozin
Canagliflozin 100mg orally once daily
Other Names:
  • TA-7284, Canaglu

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With 30% Decline in Estimated Glomerular Filtration Rate (eGFR) From Baseline at Week 104
Time Frame: Week 104
Percentage of participants with 30% decline in eGFR was calculated by multiple imputation method for missing data.
Week 104

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With 40% Decline in eGFR From Baseline at Week 104
Time Frame: Week 104
Percentage of participants with 40% decline in eGFR was calculated by multiple imputation method for missing data.
Week 104
Change From Baseline in eGFR at Week 104
Time Frame: Baseline and Week 104
Baseline and Week 104
Composite Endpoint of End-stage Renal Disease (ESRD), Doubling of Serum Creatinine, Renal Death, and Cardiovascular (CV) Death
Time Frame: up to approximately 108 weeks
up to approximately 108 weeks
Change From Baseline in Percentage of Urine Albumin-to -Creatinine Ratio (UACR) at Week 104
Time Frame: Baseline and Week 104
Baseline and Week 104

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanabe Pharma Corporation

Investigators

  • Study Director: General Manager, Tanabe Pharma Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

January 7, 2026

Last Update Submitted That Met QC Criteria

December 15, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

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.

Clinical Trials on Diabetic Nephropathy

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe