Efficacy and Safety Outcomes Among De Novo Renal Transplant Recipients Managed by C2 Monitoring of Cyclosporine A Microemulsion: Results of a 12-Month, Randomized, Multicenter Study

Abstract

Both C2 target ranges investigated showed excellent and nearly equivalent outcomes at 12 months. The decision to target the higher or lower end of these C2 ranges should be made on an individual basis, taking into account patient and graft characteristics, and co-medication.

Early Cyclosporine C0 and C2 Monitoring in De Novo Kidney Transplant Patients: A Prospective Randomized Single-Center Pilot Study

“…Thus, the theoretical advantages of optimizing CsA bioavailability with C2 may well be offset by logistical complications. One may also wonder, why in a well organized study setting with C2 monitoring (19) only one third of patients were within the target C2 range at one year. Due to the logistical difficulties described above, we could not extend the double sampling beyond the primary hospitalization.…”

Three-years experience with Neoral C2 monitoring adjusted to a target range of 500–600 ng/ml in long-term renal transplant recipients receiving dual immunosuppressive therapy

“…The MO2ART [8] study evaluated two C 2 target ranges (800Á1000 and 600Á800 ng/ml at Months 7Á12) up to 1 year post-transplant and showed excellent and nearly equivalent outcomes at 12 months. To date, there is little knowledge regarding the optimal C 2 -CsA level in maintenance patients beyond the first year post-transplant [9,10].…”

“…Recently [7,8], CsA-C 2 monitoring has been investigated in clinical randomized controlled trials in which de novo renal transplant recipients received triple immunosuppressive therapy. The MO2ART [8] study evaluated two C 2 target ranges (800Á1000 and 600Á800 ng/ml at Months 7Á12) up to 1 year post-transplant and showed excellent and nearly equivalent outcomes at 12 months.…”

The Contribution of Pharmacological Agents in the History of Organ Transplantation

“…Moreover, to further simplify TDM, it was proposed that the concentration 2 hours after administration (C2) be used, because it has the strongest correlation with AUC0-4 [47]. Called C2 monitoring, its clinical usefulness was verified in prospective multicenter studies in renal [48], liver [49], and heart transplant patients [50]. In this way, the pharmacological agents used in transplantation medicine-namely calcineurin inhibitorspromoted the evolution of TDM and helped to realize the concept of individualized therapy.…”