A Study Investigating the Renal Tolerability, Efficacy, and Safety of a CNI-free Versus a Standard Regimen in de Novo Heart Transplant (HTx) Recipients

Everolimus 0.25mg, 0.75mg or 1.0mg based on blood levels (5-10 ng/mL)

10 mg, 25 mg, 50 mg or 100 mg capsule according to blood levels for CNI-regimen group. For CNI-free-regimen dispense on month 6 to 9 only

0.5 mg, 1 mg, or 5 mg capsule given according to blood levels for CNI-regimen. For CNI-free-regimen give on month 6 to 9 only

180 mg or 360 mg tablet dosed 1440-2280 mg per day

250 mg or 500 mg tablets with a dose of 1500-3000 mg per day

according to local standard: 0.05-0.3 mg/kg of prednisolone or equivalent