A National Multi-center Randomized, Open Label Study to Evaluate Efficacy and Safety of Everolimus With EC-MPS Compared to Standard Treatment Combination Tacrolimus and EC-MPS in de Novo Liver Transplant Recipients
NCT ID: NCT01625377
Last Updated: 2016-04-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
188 participants
INTERVENTIONAL
2012-12-31
2015-03-31
Brief Summary
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The renal function was estimated by glomerular filtration rate.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Tacrolimus
From transplantation to randomization: Basiliximab (40mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids. From randomization to month 6 : tacrolimus (C0 6-10 ng/ml) + mycophenolic acid 1440 mg/d ± oral corticosteroids
tacrolimus
Arm 1 : tacrolimus (C0 6-10 ng/ml) from D3-D5 post-transplantation to month 6 post-transplantation. Arm 2 : tacolimus (C0 6-10 ng/ml) from D3-D5 post-transplantation to 16 weeks post-transplantation at the latest.
Basiliximab
Basiliximab was supplied to the participating centers as marketed, i.e. in packs containing one vial of 20-mg powder, and water for injection (WFI). 20 mg at D0 and D4
Mycophenolic Acid
Dose of 1440 mg/day from transplantation to month 6 post- transplantation
Corticosteroids
Administration of oral corticosteroid therapy was at the discretion of the centers according to their usual practice
Everolimus (RAD001)
From transplantation to randomization: Basiliximab (40mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids.
From randomization to month 6 : everolimus (recommended starting dose of 2 mg/day, then adjusted to achieve the target 6 ≤ C0 ≤ 10 ng/mL, until W24) + mycophenolic acid 1440 mg/d ± oral corticosteroids. The dose of tacrolimus was reduced by 50% twice: at the introduction of everolimus and at week 8 post-transplantation. Tacrolimus had to be finally discontinued in week 12 post-transplantation (by week 16 at the latest).
tacrolimus
Arm 1 : tacrolimus (C0 6-10 ng/ml) from D3-D5 post-transplantation to month 6 post-transplantation. Arm 2 : tacolimus (C0 6-10 ng/ml) from D3-D5 post-transplantation to 16 weeks post-transplantation at the latest.
everolimus
Arm 1: no everolimus Arm 2: everolimus (C0 6-10 ng/ml) from randomization to month 6 post-transplantation
Basiliximab
Basiliximab was supplied to the participating centers as marketed, i.e. in packs containing one vial of 20-mg powder, and water for injection (WFI). 20 mg at D0 and D4
Mycophenolic Acid
Dose of 1440 mg/day from transplantation to month 6 post- transplantation
Corticosteroids
Administration of oral corticosteroid therapy was at the discretion of the centers according to their usual practice
Interventions
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tacrolimus
Arm 1 : tacrolimus (C0 6-10 ng/ml) from D3-D5 post-transplantation to month 6 post-transplantation. Arm 2 : tacolimus (C0 6-10 ng/ml) from D3-D5 post-transplantation to 16 weeks post-transplantation at the latest.
everolimus
Arm 1: no everolimus Arm 2: everolimus (C0 6-10 ng/ml) from randomization to month 6 post-transplantation
Basiliximab
Basiliximab was supplied to the participating centers as marketed, i.e. in packs containing one vial of 20-mg powder, and water for injection (WFI). 20 mg at D0 and D4
Mycophenolic Acid
Dose of 1440 mg/day from transplantation to month 6 post- transplantation
Corticosteroids
Administration of oral corticosteroid therapy was at the discretion of the centers according to their usual practice
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Recipient of a liver from a living donor or cadaveric non heart beating donor
* ABO incompatible transplant graft
* Transplantation following autoimmune liver hepatitis, primitive sclerosing cholangitis or primitive biliary cirrhosis
* Estimated glomerular filtration rate ≤ 30ml/min at selection
* History of malignancy within the 5 past years, other than non-metastatic basal or squamous cell carcinoma and hepatocellular carcinoma
* Alpha-foeto-protein \> 1000 ng/ml (only in case of hepatocellular carcinoma)
18 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
Besançon, , France
Novartis Investigative Site
Bordeaux, , France
Novartis Investigative Site
Chambray-lès-Tours, , France
Novartis Investigative Site
Clichy, , France
Novartis Investigative Site
Créteil, , France
Novartis Investigative Site
Grenoble, , France
Novartis Investigative Site
Lille, , France
Novartis Investigative Site
Marseille, , France
Novartis Investigative Site
Montpellier, , France
Novartis Investigative Site
Nice, , France
Novartis Investigative Site
Paris, , France
Novartis Investigative Site
Rennes, , France
Novartis Investigative Site
Toulouse, , France
Novartis Investigative Site
Villejuif, , France
Countries
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Other Identifiers
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2012-000137-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CRAD001HFR02
Identifier Type: -
Identifier Source: org_study_id
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