At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multi-center, Randomized, Open-label, Parallel Group Study Investigating the Renal Tolerability, Efficacy and Safety of a CNI-free Regimen (Everolimus and MPA) Versus a CNI-regimen With Everolimus in Heart Transplant Recipients
In Brief
A Phase 4 clinical trial evaluating Everolimus (EVR), cyclosporine A (CyA), and 4 other interventions for Heart Transplantation. Completed, enrolled 162 participants across 9 sites.
Detailed Summary
This study will assess whether a calcineurin inhibitor (CNI)-free regimen with everolimus and mycophenolic acid is associated with a better renal outcome as compared to the standard regimen containing cyclosporine A (which belongs to the class of CNIs) and everolimus; while both treatments are expected to be comparable with respect to efficacy.
Study Details
Timeline
Interventions
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