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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4 December 2018 |
Main ID: |
EUCTR2013-004494-28-ES |
Date of registration:
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22/05/2014 |
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 Kidney Disease
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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 |
Date of first enrolment:
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25/07/2014 |
Target sample size:
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3700 |
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: Single-blind run-in; 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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China
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Czech Republic
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France
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Germany
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Hong Kong
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Hungary
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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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Slovakia
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South Africa
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Spain
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Taiwan
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Ukraine
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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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Departamento Regulatory y Start Up
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Address:
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Parque Empresarial Cristalia. C/Vía de los Poblados 3, edificio 7/8, 5ª planta
28033
Madrid
Spain |
Telephone:
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0034918062000 |
Email:
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ensayosclinicos@quintiles.com |
Affiliation:
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Quintiles S.L. |
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Name:
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Departamento Regulatory y Start Up
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Address:
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Parque Empresarial Cristalia. C/Vía de los Poblados 3, edificio 7/8, 5ª planta
28033
Madrid
Spain |
Telephone:
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0034918062000 |
Email:
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ensayosclinicos@quintiles.com |
Affiliation:
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Quintiles S.L. |
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Key inclusion & exclusion criteria
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Inclusion criteria: -T2DM with a HbA1c ? 6.5% to ? 10.5%, 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: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1200 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2500
Exclusion criteria: - History of diabetic ketoacidosis or type 1 diabetes mellitus - History of hereditary glucose-galactose malabsorption or primary renal glucosuria - History of hyperkalemia requiring treatment, or blood potassium level >5.5 mmol/L at baseline - Use of mineralocorticoid receptor antagonists (MRA) or a direct renin inhibitor (DRI) - 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
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 Kidney Disease MedDRA version: 17.0
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: Canagliflozin 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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Timepoint(s) of evaluation of this end point: Baseline, up to Month 66
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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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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 MI, non-fatal stroke, hospitalized congestive heart failure, and hospitalized unstable angina ? the renal composite endpoint of ESKD, doubling of serum creatinine, and renal death ? all-cause 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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Secondary Outcome(s)
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Timepoint(s) of evaluation of this end point: Baseline, up to Month 66
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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
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Secondary ID(s)
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2013-004494-28-GB
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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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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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