Open-Label, Randomized Study of Transition From Tacrolimus to Sirolimus Immunosuppression in Renal Allograft Recipients
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Data
2016
Autores
Tedesco-Silva, Helio [UNIFESP]
Peddi, V. Ram
Sanchez-Fructuoso, Ana
Marder, Brad A.
Russ, Graeme R.
Diekmann, Fritz
Flynn, Alison
Hahn, Carolyn M.
Li, Huihua
Tortorici, Michael A.
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Artigo
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Background. 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.
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.
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Citação
Transplantation Direct. Philadelphia, v. 2, n. 4, p. -, 2016.