OBJECTIVETo investigate the efficacy and safety of sirolimus in management of chronic allograft nephropathy (CAN).

METHODSA retrospective study was conducted involving 31 CAN patients followed up since March 2002, who experienced a change from a calcineurin inhibitor (CNI)-based regimen to a SRL-based regimen. Serum creatinine (Cr) in these patients was compared before and after the regimen change, and the adverse events associated with SRL were analyzed.

RESULTSTill March 2007 when the study closed, 15 patients reached the primary endpoint for resuming dialysis, 8 had improved and 8 had stable renal function. In patients with high Cr(0)(> or =3 mg/L, n=12), 9 resumed dialysis and 2 had improved renal function, but one of the patients with renal improvement eventually died due to infection; in the patients with low Cr(0)(<3 mg/L, n=19), 5 resumed dialysis, 8 had stable renal function and 6 had improved renal function, showing significant difference between the 2 groups (P=0.003). Altogether 14 patients reached the secondary endpoint for ceasing SRL for severe infection (5 patients, of whom 4 resumed dialysis and 1 died of infection) or adverse events associated with SRL (9 patients, of whom 4 resumed dialysis, 2 had stable and 3 had improved renal function). Hyperlipidemia (51.6%), leukocytopenia (41.9%), mouth ulcer (29.0%) and liver function lesion (16.1%) were the commonest adverse events in these patients, and totalling 13 severe adverse events were recorded, including 2 fatal cerebral hemorrhage, 3 fatal infection episodes, and 8 pulmonary and urinary infections that require hospitalization.

CONCLUSIONConversion from a CNI-based to SRL-based regimen can be effective for some CAN cases, especially for those with Cr(0) below 3 mg/L. Attention must be given to adverse events like hyperlipidemia and leukocytopenia, as well as the related cerebral vascular accidents and infections.