Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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28 February 2019 |
Main ID: |
EUCTR2013-004494-28-GB |
Date of registration:
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21/02/2014 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A Study of the Effects of Canagliflozin on Renal and Cardiovascular Outcomes in Subjects With Type 2 Diabetes Mellitus and Diabetic Nephropathy
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Scientific title:
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A Randomized, Double-blind, Event-driven, Placebo-controlled, Multicenter Study of the Effects of Canagliflozin on Renal and Cardiovascular Outcomes in Subjects With Type 2 Diabetes Mellitus and Diabetic Nephropathy - 28431754DNE3001 |
Date of first enrolment:
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18/07/2014 |
Target sample size:
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4200 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-004494-28 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: no
Cross over: no
Other: yes
Other trial design description: Event driven
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
Number of treatment arms in the trial: 2
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Argentina
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Australia
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Brazil
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Bulgaria
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Canada
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Chile
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China
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Colombia
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Czech Republic
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Egypt
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France
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Germany
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Guatemala
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Hungary
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India
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Italy
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Japan
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Korea, Republic of
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Lithuania
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Malaysia
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Mexico
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New Zealand
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Philippines
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Poland
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Romania
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Russian Federation
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Serbia
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Slovakia
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South Africa
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Spain
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Sri Lanka
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Taiwan
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Ukraine
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United Arab Emirates
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United Kingdom
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United States
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Contacts
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Name:
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Clinical Registry Group
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Address:
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Archimedesweg 29
2333 CM
Leiden
Netherlands |
Telephone:
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0031 (0)71 524 |
Email:
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ClinicalTrialsEU@its.jnj.com |
Affiliation:
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Janssen Pharmaceutica N.V. |
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Name:
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Clinical Registry Group
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Address:
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Archimedesweg 29
2333 CM
Leiden
Netherlands |
Telephone:
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0031 (0)71 524 |
Email:
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ClinicalTrialsEU@its.jnj.com |
Affiliation:
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Janssen Pharmaceutica N.V. |
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Key inclusion & exclusion criteria
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Inclusion criteria: -T2DM with a HbA1c = 6.5% and to = 12%, with an eGFR = 30 to < 90 mL/min/1.73m2 - Participants need to be on a maximum tolerated labeled daily dose of an angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB) for at least 4 weeks prior to randomization - Must have an urine albumin to creatinine ratio (UACR) > 300 mg/g to = 5000 mg/g Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 2800 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1400
Exclusion criteria: - History of diabetic ketoacidosis or type 1 diabetes mellitus - History of hereditary glucose-galactose malabsorption or primary renal glucosuria - Renal disease that required treatment with immunosuppressive therapy - Known significant liver disease - Current or history of New York Heart Association (NYHA) Class IV heart failure -Blood Potassium level >5.5 millimole ( mmol) / litre (L) during screening.
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
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Type 2 Diabetes Mellitus and Diabetic Nephropathy
MedDRA version: 20.1
Level: LLT
Classification code 10045242
Term: Type II diabetes mellitus
System Organ Class: 100000004861
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Intervention(s)
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Trade Name: Invokana Product Name: Invokana Product Code: JNJ-28431754-ZAE Pharmaceutical Form: Capsule INN or Proposed INN: CANAGLIFLOZIN CAS Number: 928672-86-0 Other descriptive name: CANAGLIFLOZIN Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Main Objective: In subjects with T2DM, Stage 2 or 3 CKD and macroalbuminuria who are receiving standard of care, to assess the efficacy of canagliflozin relative to placebo in reducing the composite endpoint of ESKD, doubling of serum creatinine, and renal or CV death.
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Primary end point(s): -Time to the first occurrence of an event in the primary composite endpoint
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Timepoint(s) of evaluation of this end point: Baseline, up to approximately Month 66
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Secondary Objective: In subjects with T2DM, Stage 2 or 3 CKD and macroalbuminuria who are receiving standard of care, to assess the efficacy of canagliflozin relative to placebo in reducing: •the CV composite endpoint of CV death, non-fatal myocardial infarction (MI)MI, non-fatal stroke, hospitalized congestive heart failure, and hospitalized unstable angina • the composite endpoint of CV death and hospitalized congestive heart failure •the composite endpoint of CV death, non-fatal myocardial infarction (MI), and non-fatal stroke (ie, 3-point major adverse cardiac event [MACE]) •Hospitalized congestive heart failure • the renal composite endpoint of ESKD, doubling of serum creatinine, and renal death •CV death • all-cause death
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Secondary Outcome(s)
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Secondary end point(s): -Time to the first occurrence of an event in the CV composite endpoint -Time to the first occurrence of an event in the renal composite endpoint -Time to all-cause death -Time to the first occurrence of an event in the CV Composite Endpoint of CV Death, non-fatal MI, and non-fatal stroke (ie, 3-point MACE); and Hospitalised Congestive Heart Failure -Time to CV death
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Timepoint(s) of evaluation of this end point: Baseline, up to approximately Month 66
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Secondary ID(s)
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28431754DNE3001
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Source(s) of Monetary Support
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Janssen Research and Development, LLC
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Ethics review
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Status: Approved
Approval date:
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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