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

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ClinicalTrials.gov Identifier: NCT03436693
Recruitment Status : Recruiting
First Posted : February 16, 2018
Last Update Posted : April 5, 2018
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation

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
Diabetic Nephropathy Drug: Canagliflozin Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 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 : February 15, 2018
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Canagliflozin 100mg Drug: Canagliflozin
Canagliflozin 100mg orally once daily
Other Name: TA-7284, Canaglu

Placebo Comparator: Placebo Drug: Placebo
Placebo orally once daily




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

Secondary Outcome Measures :
  1. Change from baseline in eGFR at each assessment time point [ Time Frame: 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 [ Time Frame: up to approximately 104 weeks ]
  3. Change from baseline in urine albumin-to-creatinine ratio (UACR) at each assessment time point [ Time Frame: Baseline to Week 104 ]


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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03436693


Contacts
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Contact: Clinical Trials Information Desk, to prevent miscommunication, please email: cti-inq-ml@ml.mt-pharma.co.jp

Locations
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Japan
Research site Recruiting
Aichi, Japan
Research site Recruiting
Chiba, Japan
Research site Recruiting
Fukuoka, Japan
Research site Recruiting
Fukushima, Japan
Research site Recruiting
Gunma, Japan
Research site Recruiting
Hiroshima, Japan
Research site Recruiting
Hokkaido, Japan
Research site Recruiting
Hyogo, Japan
Research site Recruiting
Ibaraki, Japan
Research site Recruiting
Kagawa, Japan
Research site Recruiting
Kagoshima, Japan
Research site Recruiting
Kanagawa, Japan
Research site Recruiting
Kumamoto, Japan
Research site Recruiting
Mie, Japan
Research site Recruiting
Nagano, Japan
Research site Recruiting
Nagasaki, Japan
Research site Recruiting
Oita, Japan
Research site Recruiting
Okinawa, Japan
Research site Recruiting
Osaka, Japan
Research site Recruiting
Saitama, Japan
Research site Recruiting
Shizuoka, Japan
Research site Recruiting
Tochigi, Japan
Research site Recruiting
Tokyo, Japan
Research site Recruiting
Wakayama, Japan
Research site Recruiting
Yamagata, Japan
Research site Recruiting
Yamaguchi, Japan
Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation
Investigators
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Study Director: General Manager Mitsubishi Tanabe Pharma Corporation

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Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT03436693     History of Changes
Other Study ID Numbers: TA-7284-14
First Posted: February 16, 2018    Key Record Dates
Last Update Posted: April 5, 2018
Last Verified: April 2018

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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:
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Diabetes Complications
Diabetes Mellitus
Hypoglycemic Agents
Kidney Diseases
Diabetic Nephropathies
Urologic Diseases
Endocrine System Diseases
Canagliflozin
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs