Introduction of everolimus in kidney transplant recipients at a late posttransplant stage

Table 1 Summary of late everolimus conversion clinical trials

Ref.	No. of subjects/follow-up	EVLtreatment	Groups	Outcomes
ASCERTAIN[17] (2011)	394/2 yr	Conversion to EVL with CNI elimination or minimization at mean of 5.6 yr	Gp 1: CNI elimination (EVL C0, 8-12 ng/mL), n = 127 Gp 2: CNI minimization (EVL C0, 3-8 ng/mL and CNI reduced to 80%-90% below baseline), n = 144 Gp 3: control (CsA C2, > 400 ng/mL; Tac C0, > 4 ng/mL), n = 123	Graft survival: 96.9%, 94.6%, 95.1% (P = NS) Patient survival: 97.6%, 97.1%, 100% (P = NS) Comparable eGFR in 3 groups; recipients with baseline CrCl > 50 mL/min had greater increase in measured GFR after CNI elimination Adverse events resulted in discontinuation: 28.3%, 16.7%, 4.1% (Gp 1 vs GP 3, P < 0.001; Gp 2 vs Gp 3, P = 0.020)
APOLLO[18] (2015)	93/1 yr	Conversion from CNI to EVL at mean of 7 yr	Gp 1: CNI elimination (EVL C0, 6-10 ng/mL), n = 46 Gp 2: control (CsA C0, 80-150 ng/mL; Tac C0, 5-10 ng/mL), n = 47	Graft survival: 100%, 100% Patient survival: 97.8%, 97.9% (P = NS) Adjusted eGFR was significantly higher in Gp 1 within on-treatment population Adverse events resulted in discontinuation: 32.6%, 10.6% (P < 0.01)

C0: Zero hour blood level; CNI: Calcineurin inhibitor; CrCl: Creatinine clearance; CsA: Cyclosporine; eGFR: Estimated glomerular filtration rate; EVL: Everolimus; Gp: Group; No.: Number; NS: Not significant; Tac: Tacrolimus.