Table 2.
Outcomes of everolimus-based immunosuppressant as maintenance for lt recipients in prospective RCT
Ref. | Treatment group | Time (mo) from transplant surgery EVR was initiated | Key inclusion and exclusion criteria | n | Follow-up period (mo) | Efficacy | Mean improvement in CrCl (mL/min) | Safety |
De Simone et al[19] 2009 (RESCUE Study) | EVR with CNI reduction or elimination (EVR C0 3-8 ng/mL, FK C0 3-5 ng/mL or EVR C0 6-12 ng/mL with FK elimination | 12 to 60 mo | Inclusion: CrCl ≤ 60 mL/min and ≥ 20 mL/min Exclusion: Renal dysfunction not due to CNI toxicity, proteinuria ≥ 1 g/24 h, acute rejection < 6 mo, hepatitis C infection need active antiviral therapy | 72 | 12 | BPAR, graft loss or death: 8.3% in EVR group vs 4.1% in control group | -1.1 (P = 0.463) at month 6 | Higher incidence of hyperlipidemia, mouth ulceration, increased hepatitis C virus viral titer, dry skin, eczema, and rash in the EVR group |
Control: Standard exposure of FK or CsA | 73 |
BPAR: Biopsy proven acute rejection; C0: Trough level; CNI: Calcineurin inhibitor; CrCl: Creatinine clearance (based on Cockcroft-Gault formula); CsA: Cyclosporine; EVR: Everolimus; FK: Tacrolimus.