Frontiers in nephrology · 2026
Long-term outcomes of tacrolimus conversion to sirolimus in kidney transplant recipients: an eight-year follow-up.
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Tawhari Ibrahim, Park Sook, Yamani Fatmah, Ho Bing, Ansari Mohammed Javeed, Tawhari Mohammed, Leventhal Joseph, Gallon Lorenzo
Аннотация
OBJECTIVE: Calcineurin inhibitors, such as tacrolimus, are associated with long-term nephrotoxicity and renal allograft dysfunction despite evidence of improved kidney transplantation outcomes. Consequently, minimizing calcineurin inhibitor exposure has attracted considerable interest. This study aimed to investigate the long-term outcomes of late conversion of tacrolimus to sirolimus in a steroid-free immunosuppressive regimen in kidney transplant recipients.
METHODS: We conducted an 8-year retrospective analysis of outcomes in 207 kidney transplant recipients enrolled in a previous randomized clinical trial, in which patients receiving maintenance therapy with tacrolimus and mycophenolate were randomized 2:1 at 6-12 months post-transplantation to conversion from tacrolimus to sirolimus or continuation of tacrolimus.
RESULTS: Over the 8-year post-transplant follow-up, the sirolimus cohort exhibited a superior and more preserved GFR compared to the tacrolimus cohort, with a total GFR change of -1.18 mL/min/1.73 m² (95% CI, -4.86 to 3.06) with sirolimus versus -9.57 mL/min/1.73 m² (95% CI, -16.92 to -7.26) with tacrolimus, with a between-group difference of -8.39 mL/min/1.73 m². The two groups did not significantly differ in terms of graft loss, patient survival, or de novo donor-specific antibody development. The sirolimus group showed a numerically but insignificantly elevated biopsy-proven acute rejection rate. Adverse effect profiles revealed that the sirolimus group was associated with significantly lower BK viremia and cancer rates, whereas other adverse events did not significantly differ between the groups.
CONCLUSIONS: Delayed conversion from tacrolimus to sirolimus (≥6 months post-transplantation) was associated with long-term preserved estimated glomerular filtration rate without a significantly increased risk of renal allograft rejection or graft loss.
METHODS: We conducted an 8-year retrospective analysis of outcomes in 207 kidney transplant recipients enrolled in a previous randomized clinical trial, in which patients receiving maintenance therapy with tacrolimus and mycophenolate were randomized 2:1 at 6-12 months post-transplantation to conversion from tacrolimus to sirolimus or continuation of tacrolimus.
RESULTS: Over the 8-year post-transplant follow-up, the sirolimus cohort exhibited a superior and more preserved GFR compared to the tacrolimus cohort, with a total GFR change of -1.18 mL/min/1.73 m² (95% CI, -4.86 to 3.06) with sirolimus versus -9.57 mL/min/1.73 m² (95% CI, -16.92 to -7.26) with tacrolimus, with a between-group difference of -8.39 mL/min/1.73 m². The two groups did not significantly differ in terms of graft loss, patient survival, or de novo donor-specific antibody development. The sirolimus group showed a numerically but insignificantly elevated biopsy-proven acute rejection rate. Adverse effect profiles revealed that the sirolimus group was associated with significantly lower BK viremia and cancer rates, whereas other adverse events did not significantly differ between the groups.
CONCLUSIONS: Delayed conversion from tacrolimus to sirolimus (≥6 months post-transplantation) was associated with long-term preserved estimated glomerular filtration rate without a significantly increased risk of renal allograft rejection or graft loss.