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Published on: November 8, 2015
Open-Label, Randomized Study of Transition From Tacrolimus to Sirolimus Immunosuppression in Renal Allograft
Helio Tedesco-Silva1, V Ram Peddi2, Ana Sánchez-Fructuoso3
1Divisão de Nefrologia, Hospital do Rim, São Paulo, Brazil.
Unlabelled:
Calcineurin inhibitor-associated nephrotoxicity and other adverse events have prompted efforts to minimize/eliminate calcineurin inhibitor use in kidney transplant recipients.
Methods:
This open-label, randomized, multinational study evaluated the effect of planned transition from tacrolimus to sirolimus on kidney function in renal allograft recipients. Patients received tacrolimus-based immunosuppression and then were randomized 3 to 5 months posttransplantation to transition to sirolimus or continue tacrolimus. The primary end point was percentage of patients with 5 mL/min per 1.73 m(2) or greater improvement in estimated glomerular filtration rate from randomization to month 24.
Results:
The on-therapy population included 195 patients (sirolimus, 86; tacrolimus, 109). No between-group difference was noted in percentage of patients with 5 mL/min per 1.73 m(2) or greater estimated glomerular filtration rate improvement (sirolimus, 34%; tacrolimus, 42%; P = 0.239) at month 24. Sirolimus patients had higher rates of biopsy-confirmed acute rejection (8% vs 2%; P = 0.02), treatment discontinuation attributed to adverse events (21% vs 3%; P < 0.001), and lower rates of squamous cell carcinoma of the skin (0% vs 5%; P = 0.012).
Conclusions:
Our findings suggest that renal function improvement at 24 months is similar for patients with early conversion to sirolimus after kidney transplantation versus those remaining on tacrolimus.
Insights
Early conversion from tacrolimus to sirolimus in kidney transplant recipients showed similar renal function improvement compared to continuing tacrolimus. However, the sirolimus group experienced higher rates of acute rejection and adverse events.
Area of Science:
- Nephrology and Transplant Immunology
- Pharmacological Immunosuppression
Background:
- Calcineurin inhibitors (CNIs) like tacrolimus are standard immunosuppressants post-kidney transplant.
- CNI-associated nephrotoxicity and other adverse events necessitate strategies to minimize their use.
Purpose of the Study:
- To evaluate the impact of planned early conversion from tacrolimus to sirolimus on kidney function in renal transplant recipients.
- To compare estimated glomerular filtration rate (eGFR) changes between patients switched to sirolimus and those continuing tacrolimus.
Main Methods:
- Open-label, randomized, multinational study involving 195 renal allograft recipients.
- Patients received tacrolimus-based immunosuppression and were randomized 3-5 months post-transplant to either switch to sirolimus or continue tacrolimus.
- Primary endpoint: percentage of patients with ≥5 mL/min/1.73 m² eGFR improvement from randomization to 24 months.
Main Results:
- No significant difference in eGFR improvement at 24 months between the sirolimus (34%) and tacrolimus (42%) groups (P=0.239).
- Sirolimus group had higher rates of biopsy-confirmed acute rejection (8% vs 2%; P=0.02).
- Sirolimus group experienced more treatment discontinuations due to adverse events (21% vs 3%; P<0.001) but fewer skin cancers (0% vs 5%; P=0.012).
Conclusions:
- Early conversion to sirolimus demonstrates comparable renal function outcomes to continuing tacrolimus at 24 months post-kidney transplant.
- Sirolimus conversion is associated with increased risks of acute rejection and adverse event-related discontinuations.
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