title: Open-Label, Randomized Study of Transition From Tacrolimus to Sirolimus Immunosuppression in Renal Allograft Recipients.
abstract: 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.
authors: Divisão de Nefrologia, Hospital do Rim, São Paulo, Brazil.
authors: Helio
authors: H
authors: Tedesco-Silva
authors: Department of Transplantation, California Pacific Medical Center, San Francisco, CA.
authors: V Ram
authors: VR
authors: Peddi
authors: Department of Nephrology, Hospital Clínico San Carlos, Madrid, Spain.
authors: Ana
authors: A
authors: Sánchez-Fructuoso
authors: Internal Medicine and Nephrology, Presbyterian/St Luke's Medical Center, Denver, CO.
authors: Brad A
authors: BA
authors: Marder
authors: Renal and Transplant Service, Royal Adelaide Hospital, Adelaide South, Australia.
authors: Graeme R
authors: GR
authors: Russ
authors: Department of Nephrology and Renal Transplantation, Hospital Clínic de Barcelona, Barcelona, Spain.
authors: Fritz
authors: F
authors: Diekmann
authors: Pfizer, Global Innovative Pharma, Collegeville, PA.
authors: Alison
authors: A
authors: Flynn
authors: Pfizer, Global Innovative Pharma, Collegeville, PA.
authors: Carolyn M
authors: CM
authors: Hahn
authors: Pfizer, Global Innovative Pharma, Collegeville, PA.
authors: Huihua
authors: H
authors: Li
authors: Pfizer, Global Innovative Pharma, Collegeville, PA.
authors: Michael A
authors: MA
authors: Tortorici
authors: Pfizer, Global Innovative Pharma, Collegeville, PA.
authors: Seth L
authors: SL
authors: Schulman