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Introduction: Everolimus (EVR), allows for reduction in CNI exposure with preserved renal function without loss of efficacy in renal transplant recipients (RTs). Data from earlier studies suggests that targeting EVR C0 levels to >3ng/mL may provide optimal benefits in RTs. This study explores the optimal EVR C0 level by correlating trough levels of EVR at 12 months (M) with efficacy and safety parameters. Methods: This 24M, randomized, multi-center, openlabel, non-inferiority study compared 2 target trough levels of EVR (C0 3-8ng/mL or C0 6-12ng/mL) with reduced CsA versus control group receiving enteric-coated mycophenolate sodium (MPA) 1.44g/day with standard CsA exposure. All RTs received basiliximab induction and steroids as per center practice. The objective of this post-hoc analysis was to correlate EVR C0 ranges with key efficacy and safety parameters including % of RTs with selected renal function events by 12M. Pooled analysis using the geometric mean of all measured EVR C0 levels up to the time of outcome or last study visit (12M) were used to correlate with key outcomes. Results: Donor and recipient characteristics were comparable between groups. Both EVR groups were statistically non-inferior to the MPA control group for the primary composite efficacy failure (treated biopsy proven acute rejection [BPAR], graft loss, death or loss to follow up) and the renal function safety endpoints at 12M. Mean CsA C0 at 12M were 55, 49 and 137 ng/mL for 3-8, 6-12ng/mL EVR and MPA groups respectively, reflecting a 60% reduction in CsA levels for both EVR groups. Mean EVR C0 at 12M were 5.2 and 7.9ng/mL for 3-8 and 6-12ng/ mL groups respectively. (Results listed in table). The probability of decreased glomerular filtration rate (GFR) correlates with CsA C0, but not with EVR C0 levels. Conclusions: EVR C0 range of 3-<8ng/ mL during the first 12M provided similar efficacy and renal function outcomes to MPA control. In addition, EVR C0 target of 3-<8ng/ml had less proteinuria and other adverse events compared to higher EVR C0 targets. Therefore, EVR C0 range of 3-<8ng/mL appears to be the optimal EVR C0 target range in de novo RTs receiving reduced exposure CsA. [Table] EVR C0 levels and efficacy and safety outcomes in patients

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Cyclosporin A has been associated with an apparent increased incidence of non Hodgkins lymphoma, most often in conjunction with multiple immunosuppressive agents. We report a patient who developed a non Hodgkins lymphoma arising in the right tonsillar fossa six months following renal transplantation. The development of the lymphoma was associated with seroconversion for the Epstein Barr capsid antigen and nuclear antigen. The patient was receiving cyclosporin A alone as immunosuppression.