Use of Enteric-Coated Mycophenolate Sodium in De Novo Renal Transplant Recipients With High Incidence of Delayed Graft Function

Abstract

Patients with delayed graft function (DGF) are at risk of increased incidence for acute rejection episodes (ARE). Mycophenolate mofetil or induction therapy has produced a reduction in ARE incidence. An open, prospective, 3-month trial was performed in a group of Argentinian renal transplant recipients. We recruited 46 patients, 71.7% men, aged 41.7 ± 13.8 years; including 36 (78.3%) recipients of cadaveric donors (CD) who were aged 43.4 ± 15.5 years with a cold ischemia time of 19.4 hours ± 5.4 minutes, and 10 (27.7%) recipients of living donors (LD) aged 37.8 ± 12.9 years. HLA mismatches ≥ 3 were observed in 58.4% of CD and in 7% of LD. All patients received two doses of basiliximab (20 mg each, days 0 and 4), cyclosporine microemulsion (CsA-ME) monitored by the second-hour concentrations (C 2), enterio-coated mycophenolate sodium (EC-MPS; 720 mg twice a day, and steroids. A 58% incidence of DGF was observed. At the end of the third month the incidence of biopsy-proven ARE was 15%, with a median serum creatinine of was 1.54 ± 0.42 mg/dL, including three grafts lost. Two patients died. No patient required EC-MPS dose discontinuation but 20% of patients required dose adjustments. The absence of discontinuations and the low incidence of dose adjustments of EC-MPS in this high-risk de novo population provided support of a suitable tolerability profile for this EC-MPS, and the possibility to impact efficacy results.