Objective: Treatment with sirolimus (SRL) is a potential therapeutic option for renal transplant recipients, especially those who have developed chronic graft nephropathy (CGN) or a neoplasm. Our aim was to analyze the efficacy and safety of conversion to SRL in renal transplant recipients.
Materials and methods: We undertook a retrospective study of 85 patients converted to SRL, 47% for tumors, 39% for CGN, and 14% for other causes. The follow-up period was 34 months (range, 1-93 months).
Results: Baseline creatinine was 1.8 +/- 0.69 mg/dL (1.6 +/- 0.59 for tumors and 2.3 +/- 0.6 for CGN). At 1 year, the creatinine was the same in both groups: 1.8 mg/dL (P = NS). Graft survival at 12 months was 89% (81% for tumors, 81% for CGN, and 100% for other causes). SRL was withdrawn in 34% of patients: 18% for severe side effects, 7% for patient death, and 9% for graft loss. The serum creatinine and proteinuria were significantly increased among those subjects who returned to dialysis because of CGN compared with those with conserved renal function. Patients who developed pneumonitis showed a lower baseline aMDRD, but no difference in SRL levels. Side effects occurred in 40% of patients, with no difference in renal function, proteinuria, or SRL levels. Renal function showed a significant improvement in the patients who continued SRL (aMDRD 45.7 vs 50.7 mL/min/1.73 m(2) at 12 months; P = .08), more marked among those who converted due to CGN. Increases were seen in levels of serum lipids, as well as in the percentage of patients treated with statins. Proteinuria increased significantly, as did the percentage of patients treated with ACE inhibitors/ARA2.
Conclusions: Conversion to SRL in patients with CGN was safe when renal function had not undergone marked worsening and there was no proteinuria. Patients who were converted experienced an improvement in renal function.