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

Sponsor
Mitsubishi Tanabe Pharma Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT03436693
Collaborator
(none)
308
Enrollment
26
Locations
2
Arms
35.2
Actual Duration (Months)
11.8
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
308 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy and Safety of Canagliflozin (TA-7284) in Patients With Diabetic Nephropathy
Actual Study Start Date :
Feb 15, 2018
Actual Primary Completion Date :
Jan 21, 2021
Actual Study Completion Date :
Jan 21, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Canagliflozin 100mg

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

    		•
    Placebo Comparator: Placebo

    Drug: Placebo
    Placebo orally once daily

    Outcome Measures

    Primary Outcome Measures

    1. The proportion of subjects with a decline in estimated glomerular filtration rate (eGFR) from baseline at Week 104 [Baseline and Week 104]

    Secondary Outcome Measures

    1. Change from baseline in eGFR at each assessment time point [Baseline to Week 104]

    2. 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 [up to approximately 104 weeks]

    3. Change from baseline in urine albumin-to-creatinine ratio (UACR) at each assessment time point [Baseline to Week 104]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research site Aichi Japan
    2 Research site Chiba Japan
    3 Research site Fukuoka Japan
    4 Research site Fukushima Japan
    5 Research site Gunma Japan
    6 Research site Hiroshima Japan
    7 Research site Hokkaido Japan
    8 Research site Hyogo Japan
    9 Research site Ibaraki Japan
    10 Research site Kagawa Japan
    11 Research site Kagoshima Japan
    12 Research site Kanagawa Japan
    13 Research site Kumamoto Japan
    14 Research site Mie Japan
    15 Research site Nagano Japan
    16 Research site Nagasaki Japan
    17 Research site Oita Japan
    18 Research site Okinawa Japan
    19 Research site Osaka Japan
    20 Research site Saitama Japan
    21 Research site Shizuoka Japan
    22 Research site Tochigi Japan
    23 Research site Tokyo Japan
    24 Research site Wakayama Japan
    25 Research site Yamagata Japan
    26 Research site Yamaguchi Japan

    Sponsors and Collaborators

    • Mitsubishi Tanabe Pharma Corporation

    Investigators

    • Study Director: General Manager, Mitsubishi Tanabe Pharma Corporation

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mitsubishi Tanabe Pharma Corporation
    ClinicalTrials.gov Identifier:
    NCT03436693
    Other Study ID Numbers:
    • TA-7284-14
    First Posted:
    Feb 19, 2018
    Last Update Posted:
    Sep 5, 2021
    Last Verified:
    Sep 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Mitsubishi Tanabe Pharma Corporation
    Diabetic Nephropathy
    Canagliflozin
    Canaglu
    Diabetes Mellitus, Type 2
    Additional relevant MeSH terms:
    Kidney Diseases
    Diabetic Nephropathies
    Canagliflozin

    Study Results

    No Results Posted as of Sep 5, 2021