NDT Advance Access originally published online on April 23, 2007
Nephrology Dialysis Transplantation 2007 22(8):2316-2321; doi:10.1093/ndt/gfm181
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Influence of sirolimus on proteinuria in de novo kidney transplantation with expanded criteria donors: comparison of two CNI-free protocols
1Department of Nephrology and Renal Transplantation, Hospital Clínic, Barcelona, Spain and 2Department of Nephrology Charité Campus Mitte Berlin, Germany
Correspondence and offprint requests to: Fritz Diekmann, MD, Department of Nephrology and Renal Transplantation, Hospital Clínic, Villarroel, 170, E-08036 Barcelona, Spain. Email: fdiekman{at}clinic.ub.es
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Abstract |
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Background. The contribution of mammalian target of rapamycin (mTOR) inhibitors to proteinuria is controversial. The aim was to analyse proteinuria in suboptimal kidney calcineurin inhibitor-(CNI) free de novo immunosuppression.
Methods. All patients from our centre with donors >60 years and CNI-free treatment were included (n = 108). Patients were divided into two groups: (i) SRL group: sirolimus (SRL) + prednisone + mycophenolate mofetil (MMF) + antiCD25; (ii) MMF group: prednisone + MMF w/ or w/o antiCD25 (n = 75). Follow-up was 12 months.
Results. Donors were slightly younger in the SRL group (68 vs 71 years; P < 0.05), receptor age (67 vs 65 years) was not significantly different. Patient survival in the MMF group was 88 vs 94% in the SRL group, however, these differences did not reach statistical significance. One-year graft survival censored for death was 83% in the MMF group and 94% in the SRL group. Acute rejection rate was 45% in the MMF and 15% in the SRL group (P < 0.01). The incidence of CNI introduction was higher in the MMF-group (35 vs 5; P < 0.05). The intention-to-treat analysis revealed significant differences of proteinuria [SRL vs MMF at 12 months: 461 (163–6988) vs 270 (53–3029) mg/day], which did not exist in the on-therapy (OT) analysis [SRL vs MMF at 12 months: 357 (199–1428) vs 279 (53–3029) mg/day]. New onset nephrotic range proteinuria seemed to occur slightly more frequently in SRL patients (3/33 vs 1/75; P = 0.049), however, all four cases occurred in a context of recurrent disease, or previous drug-independent damage or non-adherence. All of these patients were converted to CNI.
Conclusion. SRL-based compared with MMF-based treatment in kidney transplantation with advanced age donors is associated with an acceptable outcome, however, with increased proteinuria in the intention-to-treat analysis. A large subgroup of the patients in the MMF group experienced acute rejection and required conversion to CNI.
Keywords: calcineurin inhibitor; expanded criteria donors; IL-2 receptor antagonist; mTOR inhibitor; mycophenolate mofetil; proteinuria
Received for publication: 9.10.06
Accepted in revised form: 8. 3.07
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