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Completed

NCT Number: NCT03436693

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

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Key information

Conditions

Diabetic Nephropathy Diabetes Complications Diabetes Mellitus Diabetes Mellitus, Type 2 Diabetic Nephropathies Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Urogenital Diseases Urologic Diseases

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research site, Aichi, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Canagliflozin

Drug

Canagliflozin 100mg orally once daily

Other names: TA-7284, Canaglu

Placebo

Drug

Placebo orally once daily

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Change From Baseline in eGFR at Week 104

    Time frame: Baseline and Week 104

  3. 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

  4. Change From Baseline in Percentage of Urine Albumin-to -Creatinine Ratio (UACR) at Week 104

    Time frame: Baseline and Week 104

Sponsors and collaborators

Lead sponsor

Tanabe Pharma Corporation

Industry

Registry information

Official study title

A Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy and Safety of Canagliflozin (TA-7284) in Patients With Diabetic Nephropathy

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Feb 19, 2018
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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