Clinical trial NCT00713284 - References

Renal Transplantation — Study Evaluating Conversion From Tacrolimus to Sirolimus in Stable Kidney Transplant Recipients Receiving Myfortic

Citation(s)

•   Budde K, Curtis J, Knoll G, Chan L, Neumayer HH, Seifu Y, Hall M; ERL B302 Study Group
  Enteric-coated mycophenolate sodium can be safely administered in maintenance renal transplant patients: results of a 1-year study. Am J Transplant. 2004 Feb;4(2):237-43.
•   Flechner SM, Goldfarb D, Modlin C, Feng J, Krishnamurthi V, Mastroianni B, Savas K, Cook DJ, Novick AC
  Kidney transplantation without calcineurin inhibitor drugs: a prospective, randomized trial of sirolimus versus cyclosporine. Transplantation. 2002 Oct 27;74(8):1070-6.
•   Flechner SM, Kurian SM, Solez K, Cook DJ, Burke JT, Rollin H, Hammond JA, Whisenant T, Lanigan CM, Head SR, Salomon DR
  De novo kidney transplantation without use of calcineurin inhibitors preserves renal structure and function at two years. Am J Transplant. 2004 Nov;4(11):1776-85.
•   Hariharan S, McBride MA, Cherikh WS, Tolleris CB, Bresnahan BA, Johnson CP
  Post-transplant renal function in the first year predicts long-term kidney transplant survival. Kidney Int. 2002 Jul;62(1):311-8.
•   Merion RM, White DJ, Thiru S, Evans DB, Calne RY
  Cyclosporine: five years' experience in cadaveric renal transplantation. N Engl J Med. 1984 Jan 19;310(3):148-54.
•   Morales JM, Wramner L, Kreis H, Durand D, Campistol JM, Andres A, Arenas J, Nègre E, Burke JT, Groth CG; Sirolimus European Renal Transplant Study Group
  Sirolimus does not exhibit nephrotoxicity compared to cyclosporine in renal transplant recipients. Am J Transplant. 2002 May;2(5):436-42.
•   Mota A, Arias M, Taskinen EI, Paavonen T, Brault Y, Legendre C, Claesson K, Castagneto M, Campistol JM, Hutchison B, Burke JT, Yilmaz S, Häyry P, Neylan JF; Rapamune Maintenance Regimen Trial
  Sirolimus-based therapy following early cyclosporine withdrawal provides significantly improved renal histology and function at 3 years. Am J Transplant. 2004 Jun;4(6):953-61.
•   Nankivell BJ, Borrows RJ, Fung CL, O'Connell PJ, Allen RD, Chapman JR
  The natural history of chronic allograft nephropathy. N Engl J Med. 2003 Dec 11;349(24):2326-33.
•   Oberbauer R, Segoloni G, Campistol JM, Kreis H, Mota A, Lawen J, Russ G, Grinyó JM, Stallone G, Hartmann A, Pinto JR, Chapman J, Burke JT, Brault Y, Neylan JF; Rapamune Maintenance Regimen Study Group
  Early cyclosporine withdrawal from a sirolimus-based regimen results in better renal allograft survival and renal function at 48 months after transplantation. Transpl Int. 2005 Jan;18(1):22-8. Erratum in: Transpl Int. 2005 Mar;18(3):369.
•   Pirsch JD, Miller J, Deierhoi MH, Vincenti F, Filo RS
  A comparison of tacrolimus (FK506) and cyclosporine for immunosuppression after cadaveric renal transplantation. FK506 Kidney Transplant Study Group. Transplantation. 1997 Apr 15;63(7):977-83.
•   Reitamo S, Spuls P, Sassolas B, Lahfa M, Claudy A, Griffiths CE; Sirolimus European Psoriasis Study Group
  Efficacy of sirolimus (rapamycin) administered concomitantly with a subtherapeutic dose of cyclosporin in the treatment of severe psoriasis: a randomized controlled trial. Br J Dermatol. 2001 Sep;145(3):438-45.
•   Salvadori M, Holzer H, de Mattos A, Sollinger H, Arns W, Oppenheimer F, Maca J, Hall M; ERL B301 Study Groups
  Enteric-coated mycophenolate sodium is therapeutically equivalent to mycophenolate mofetil in de novo renal transplant patients. Am J Transplant. 2004 Feb;4(2):231-6.
•   Simmons WD, Rayhill SC, Sollinger HW
  Preliminary risk-benefit assessment of mycophenolate mofetil in transplant rejection. Drug Saf. 1997 Aug;17(2):75-92. Review.
•   Stallone G, Di Paolo S, Schena A, Infante B, Grandaliano G, Battaglia M, Gesualdo L, Schena FP
  Early withdrawal of cyclosporine A improves 1-year kidney graft structure and function in sirolimus-treated patients. Transplantation. 2003 Apr 15;75(7):998-1003.

A Pilot Study to Evaluate the Safety and Efficacy of Mycophenolate Sodium (Myfortic®) in Combination With Sirolimus (Rapamune®) in Stable Renal Allograft Recipients

Details for clinical trial NCT00713284