Steroid withdrawal at 3 months after kidney transplantation: A comparison of two tacrolimus-based regimens

Zbigniew Wlodarczyk, Janusz Walaszewski, Ferenc Perner, Stefan Vitko, Marek Ostrowski, Petr Bachleda, Franciszek Kokot, Marian Klinger, Pal Szenohradszky, Pavel Studenik, Pavel Navratil, Laszlo Asztalos, Boleslaw Rutkowski, Karoly Nagy Kalmar, David Hickey

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The 6 month prospective, randomized study compared the steroid-sparing potential of two tacrolimus-based regimens after renal transplantation. A total of 489 patients were randomized (1:1) to receive tacrolimus/mycophenolate mofetil (MMF)/steroids (n = 243; group Tac/MMF/S) or tacrolimus/azathioprine/ steroids (n = 246; group Tac/Aza/S). At 3 months, steroids were tapered off in 267 (54.6%) patients free from steroid-resistant acute rejection and with serum creatinine concentrations <160 μmol/l. The incidence of biopsy-confirmed acute rejection at month 3 was lower in group Tac/MMF/S compared with group Tac/Aza/S (18.1% vs. 26.0%, P = 0.035). Moreover, more patients in the Tac/MMF/S group met the criteria for steroid withdrawal than in the Tac/Aza/S group (60.5% vs. 48.8%; P < 0.01). The incidence of acute rejection during months 4-6 was low in all groups, both for patients on steroid-free dual therapy (Tac/MMF: 2.7%, Tac/Aza: 0.8%) and for patients who continued steroid maintenance therapy (Tac/MMF/S: 3.5%, Tac/Aza/S: 7.1%). Moreover, kidney function was well preserved in steroid-free patients with month 6 median serum creatinine levels of 119.5 μmol/l (Tac/MMF), and 115.1 μmol/l (Tac/Aza). For patients who continued to receive steroids, month 6 median creatinine levels were 130.5 μmol.l (Tac/MMF/S) and 132.8 μmol/l (Tac/Aza/S). The criteria for the selection of patients to discontinue steroids were adequate. Both tacrolimus-based regimens allowed the safe discontinuation of steroids in low-risk patients at month 3. The Tac/MMF combination was superior in the prevention of acute rejections and more patients met the chosen criteria for steroid withdrawal.

Original languageEnglish
Pages (from-to)157-162
Number of pages6
JournalTransplant International
Issue number2
Publication statusPublished - Feb 1 2005



  • Acute rejection
  • Azathioprine
  • Kidney transplantation
  • Mycophenolate mofetil
  • Steroid withdrawal
  • Tacrolimus

ASJC Scopus subject areas

  • Transplantation

Cite this

Wlodarczyk, Z., Walaszewski, J., Perner, F., Vitko, S., Ostrowski, M., Bachleda, P., Kokot, F., Klinger, M., Szenohradszky, P., Studenik, P., Navratil, P., Asztalos, L., Rutkowski, B., Kalmar, K. N., & Hickey, D. (2005). Steroid withdrawal at 3 months after kidney transplantation: A comparison of two tacrolimus-based regimens. Transplant International, 18(2), 157-162.