Efficacy, Safety and Tolerability of Everolimus in Combination With Reduced Exposure Cyclosporine or Tacrolimus in Paediatric Liver Transplant Recipients.
NCT ID: NCT01598987
Last Updated: 2017-05-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
56 participants
INTERVENTIONAL
2012-10-31
2016-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Everolimus based regimen
Conversion at Baseline from an immunosuppressive regimen which contains either cyclosporine (CsA) or tacrolimus (TAC) with or without mycophenolic acid (MPA), with or without corticosteroids in a regimen which contains everolimus combined reduced dose of either cyclosporine (CsA) or tacrolimus (TAC).
The dosing schedule was twice daily, 12 hours apart.
Introduction of everolimus with reduced cyclosporine or tacrolimus dose, the earliest 1 month and the latest 6 months after liver transplantation.
Immunosuppression after liver transplantation. Pediatric transplant recipients received a starting dose of 0.8 mg/m\^2/dose in combination wit Cyclosporine A or 2.0 mg/m\^2/dose in combination with tacrolimus, twice-daily. Thereafter, doses were adjusted to achieve everolimus C-0h blood trough level between 3 to 8 ng/ml.
Interventions
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Introduction of everolimus with reduced cyclosporine or tacrolimus dose, the earliest 1 month and the latest 6 months after liver transplantation.
Immunosuppression after liver transplantation. Pediatric transplant recipients received a starting dose of 0.8 mg/m\^2/dose in combination wit Cyclosporine A or 2.0 mg/m\^2/dose in combination with tacrolimus, twice-daily. Thereafter, doses were adjusted to achieve everolimus C-0h blood trough level between 3 to 8 ng/ml.
Eligibility Criteria
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Inclusion Criteria
Paediatric liver transplant recipients aged greater than or equal to 1 month and younger than 18 years of age.
Paediatric recipients at the earliest 1 month and latest 6 month after liver transplantation.
Exclusion Criteria
Presence of thrombosis of any major hepatic arteries, major/reconstructed hepatic veins, portal vein or inferior vena cava at any time prior to the start of study drug.
Patients with serum creatinine value \>2 times age-related ULN at Baseline or who received renal replacement therapy within one week prior to the start of study drug and patients with a confirmed spot urine protein/creatinine ratio indicating a urinary protein excretion \>500 mg/m2/24 hrs, at Baseline.
Patients with clinically significant systemic infection and/or in a critical care setting requiring life support measures such as mechanical ventilation, dialysis, or vasopressor agents.
Patients with a known hypersensitivity to the drugs used on study or their class, or to any of the excipients.
Pregnant or nursing (lactating) female patients, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive βHCG laboratory test (\>9 mIU/mL) at Baseline.
Female patients of child-bearing potential, defined as all women physiologically capable of becoming pregnant, UNLESS they agree for abstinence from sexual activity.
1 Month
17 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Los Angeles, California, United States
Novartis Investigative Site
New Haven, Connecticut, United States
Novartis Investigative Site
Chicago, Illinois, United States
Novartis Investigative Site
St Louis, Missouri, United States
Novartis Investigative Site
New York, New York, United States
Novartis Investigative Site
Charleston, South Carolina, United States
Novartis Investigative Site
Houston, Texas, United States
Novartis Investigative Site
Salt Lake City, Utah, United States
Novartis Investigative Site
Madison, Wisconsin, United States
Novartis Investigative Site
Parkville, Victoria, Australia
Novartis Investigative Site
Brussels, , Belgium
Novartis Investigative Site
Edmonton, Alberta, Canada
Novartis Investigative Site
København Ø, , Denmark
Novartis Investigative Site
Bron, , France
Novartis Investigative Site
Hanover, Germany, Germany
Novartis Investigative Site
Bonn, , Germany
Novartis Investigative Site
Essen, , Germany
Novartis Investigative Site
Hamburg, , Germany
Novartis Investigative Site
Regensburg, , Germany
Novartis Investigative Site
Tübingen, , Germany
Novartis Investigative Site
Budapest, , Hungary
Novartis Investigative Site
Budapest, , Hungary
Novartis Investigative Site
Bergamo, BG, Italy
Novartis Investigative Site
Roma, ITA, Italy
Novartis Investigative Site
Padua, PD, Italy
Novartis Investigative Site
Torino, TO, Italy
Novartis Investigative Site
Barcelona, Catalonia, Spain
Novartis Investigative Site
Madrid, Madrid, Spain
Novartis Investigative Site
Stockholm, , Sweden
Novartis Investigative Site
West Midlands, Birmingham, United Kingdom
Novartis Investigative Site
Leeds, , United Kingdom
Novartis Investigative Site
London, , United Kingdom
Countries
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Other Identifiers
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2011-003069-14
Identifier Type: -
Identifier Source: secondary_id
CRAD001H2305
Identifier Type: -
Identifier Source: org_study_id
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