612
Participants
Start Date
December 27, 2012
Primary Completion Date
March 23, 2016
Study Completion Date
March 23, 2016
Everolimus
Tacrolimus
Capsules: 0.5 mg, 1 mg or 5 mg. Dosing schedule: transplant to month 2: 4-8ng/ml, month 3 to month 12 3-5 ng/ml according to standard blood levels
Cyclosporin A
Capsules: 10 mg, 25 mg, 50 mg or 100 mg. Transplantation to month 2: 75 - 125 ng/ml, month 3 to month 12: 50 - 100 ng/ml
Enteric Coated Mycophenolate Sodium (EC-MPS)
Tablets: 180 mg or 360 mg. Dosing: duration of study 360 mg bid and no less than 360 mg daily dose
Mycophenolate mofetil (MMF)
Capsules: 250 or 500 mg. Dosing: duration of study 500 mg bid and no less than 500 mg total daily dose
Corticosteroids
A minimum dose of 5 mg prednisolon or equivalent
Simulect
Lyophilisate in vials with ampoules of sterile water for injection (5 mL), one vial containing 20 mg lyophilisate given intravenously on the day of transplantation and on day four post-transplantation.
Novartis Investigative Site, Berlin
Novartis Investigative Site, Hamburg
Novartis Investigative Site, Dijon
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Novartis Investigative Site, Strasbourg
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Novartis Investigative Site, Freiburg im Breisgau
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Lead Sponsor
Novartis Pharmaceuticals
INDUSTRY