Freedom from rejection and stable kidney function are excellent criteria for steroid withdrawal in tacrolimus-treated kidney transplant recipients.

Z. Włodarczyk, J. Wałaszewski, F. Perner, S. Vitko, M. Ostrowski, P. Bachleda, F. Kokot, M. Klinger, P. Szenohradszky, P. Studenik, P. Navratil, L. Asztalos, B. Rutkowski, K. Kalmar Nagy, D. Hickey

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Abstract

OBJECTIVES: This prospective, randomized, multicentre study investigated the efficacy and safety of two tacrolimus-based regimens and their potential to withdraw steroids. METHODS: In total 489 patients were randomised to receive either tacrolimus and MMF (n = 243) or tacrolimus and azathioprine (n = 246) concomitantly with steroids in both treatment groups. The initial oral dose of tacrolimus was 0.2 mg/kg/day, MMF dose was 1 g/day, azathioprine was administered at 1-2 mg/day. Steroids were tapered from 20 mg/day to 5 mg/day. From month 3 onwards, steroids were withdrawn in patients who were free from steroid-resistant rejection and who had serum creatinine concentrations <160 mumol/L. Study duration was 6 months. RESULTS: Patient survival at month 6 was 98.3% (Tac/MMF/S) and 98.4% (Tac/Aza/S), graft survival at 6 month was 95.0% (Tac/MMF/S) and 93.5% (Tac/Aza/S). The 6-month incidences of biopsy-proven acute rejection were 18.9% (Tac/MMF/S) compared with 26.8% (Tac/Aza/S), p = 0.038. The 6-month incidences of steroid-resistant acute rejection were 2.1% (Tac/MMF/S) and 4.9% (Tac/Aza/S), p = ns. At the end of month 3, steroid withdrawal was performed in 60.5% (Tac/MMF/S) and 48.8% (Tac/Aza/S) of patients, p <0.01. During months 4-6, 2.7% of patients in the Tac/MMF group had a biopsy-confirmed acute rejection compared with 0.8% of patients in the Tac/Aza group. In patients who continued to receive steroids, the incidences of biopsy-proven acute rejections during months 4-6 were 3.5% (Tac/MMF/S) and 7.1% (Tac/Aza/S). At study end, the steroid-free patients had an excellent kidney function, the median serum creatinine concentration was 119.5 mumol/L (Tac/MMF) and 115.1 mumol/L (Tac/Aza); the median serum creatinine of the total study group was 130.5 mumol/L (Tac/MMF/S) and 132.8 mumol/L (Tac/Aza/S). CONCLUSION: Both tacrolimus regimens are efficacious and safe. The combination of Tacrolimus and MMF achieved a lower rejection rate and permitted a higher proportion of steroid-free patients. The overall incidence of acute rejection was low and kidney function was good.

Original languageEnglish
Pages (from-to)28-31
Number of pages4
JournalAnnals of transplantation : quarterly of the Polish Transplantation Society
Volume7
Issue number3
Publication statusPublished - 2002

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Tacrolimus
Steroids
Kidney
Creatinine
Incidence
Azathioprine
Biopsy
Serum
Transplant Recipients
Graft Survival
Multicenter Studies
Safety
Survival

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Freedom from rejection and stable kidney function are excellent criteria for steroid withdrawal in tacrolimus-treated kidney transplant recipients. / Włodarczyk, Z.; Wałaszewski, J.; Perner, F.; Vitko, S.; Ostrowski, M.; Bachleda, P.; Kokot, F.; Klinger, M.; Szenohradszky, P.; Studenik, P.; Navratil, P.; Asztalos, L.; Rutkowski, B.; Nagy, K. Kalmar; Hickey, D.

In: Annals of transplantation : quarterly of the Polish Transplantation Society, Vol. 7, No. 3, 2002, p. 28-31.

Research output: Contribution to journalArticle

Włodarczyk, Z, Wałaszewski, J, Perner, F, Vitko, S, Ostrowski, M, Bachleda, P, Kokot, F, Klinger, M, Szenohradszky, P, Studenik, P, Navratil, P, Asztalos, L, Rutkowski, B, Nagy, KK & Hickey, D 2002, 'Freedom from rejection and stable kidney function are excellent criteria for steroid withdrawal in tacrolimus-treated kidney transplant recipients.', Annals of transplantation : quarterly of the Polish Transplantation Society, vol. 7, no. 3, pp. 28-31.
Włodarczyk, Z. ; Wałaszewski, J. ; Perner, F. ; Vitko, S. ; Ostrowski, M. ; Bachleda, P. ; Kokot, F. ; Klinger, M. ; Szenohradszky, P. ; Studenik, P. ; Navratil, P. ; Asztalos, L. ; Rutkowski, B. ; Nagy, K. Kalmar ; Hickey, D. / Freedom from rejection and stable kidney function are excellent criteria for steroid withdrawal in tacrolimus-treated kidney transplant recipients. In: Annals of transplantation : quarterly of the Polish Transplantation Society. 2002 ; Vol. 7, No. 3. pp. 28-31.
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abstract = "OBJECTIVES: This prospective, randomized, multicentre study investigated the efficacy and safety of two tacrolimus-based regimens and their potential to withdraw steroids. METHODS: In total 489 patients were randomised to receive either tacrolimus and MMF (n = 243) or tacrolimus and azathioprine (n = 246) concomitantly with steroids in both treatment groups. The initial oral dose of tacrolimus was 0.2 mg/kg/day, MMF dose was 1 g/day, azathioprine was administered at 1-2 mg/day. Steroids were tapered from 20 mg/day to 5 mg/day. From month 3 onwards, steroids were withdrawn in patients who were free from steroid-resistant rejection and who had serum creatinine concentrations <160 mumol/L. Study duration was 6 months. RESULTS: Patient survival at month 6 was 98.3{\%} (Tac/MMF/S) and 98.4{\%} (Tac/Aza/S), graft survival at 6 month was 95.0{\%} (Tac/MMF/S) and 93.5{\%} (Tac/Aza/S). The 6-month incidences of biopsy-proven acute rejection were 18.9{\%} (Tac/MMF/S) compared with 26.8{\%} (Tac/Aza/S), p = 0.038. The 6-month incidences of steroid-resistant acute rejection were 2.1{\%} (Tac/MMF/S) and 4.9{\%} (Tac/Aza/S), p = ns. At the end of month 3, steroid withdrawal was performed in 60.5{\%} (Tac/MMF/S) and 48.8{\%} (Tac/Aza/S) of patients, p <0.01. During months 4-6, 2.7{\%} of patients in the Tac/MMF group had a biopsy-confirmed acute rejection compared with 0.8{\%} of patients in the Tac/Aza group. In patients who continued to receive steroids, the incidences of biopsy-proven acute rejections during months 4-6 were 3.5{\%} (Tac/MMF/S) and 7.1{\%} (Tac/Aza/S). At study end, the steroid-free patients had an excellent kidney function, the median serum creatinine concentration was 119.5 mumol/L (Tac/MMF) and 115.1 mumol/L (Tac/Aza); the median serum creatinine of the total study group was 130.5 mumol/L (Tac/MMF/S) and 132.8 mumol/L (Tac/Aza/S). CONCLUSION: Both tacrolimus regimens are efficacious and safe. The combination of Tacrolimus and MMF achieved a lower rejection rate and permitted a higher proportion of steroid-free patients. The overall incidence of acute rejection was low and kidney function was good.",
author = "Z. Włodarczyk and J. Wałaszewski and F. Perner and S. Vitko and M. Ostrowski and P. Bachleda and F. Kokot and M. Klinger and P. Szenohradszky and P. Studenik and P. Navratil and L. Asztalos and B. Rutkowski and Nagy, {K. Kalmar} and D. Hickey",
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TY - JOUR

T1 - Freedom from rejection and stable kidney function are excellent criteria for steroid withdrawal in tacrolimus-treated kidney transplant recipients.

AU - Włodarczyk, Z.

AU - Wałaszewski, J.

AU - Perner, F.

AU - Vitko, S.

AU - Ostrowski, M.

AU - Bachleda, P.

AU - Kokot, F.

AU - Klinger, M.

AU - Szenohradszky, P.

AU - Studenik, P.

AU - Navratil, P.

AU - Asztalos, L.

AU - Rutkowski, B.

AU - Nagy, K. Kalmar

AU - Hickey, D.

PY - 2002

Y1 - 2002

N2 - OBJECTIVES: This prospective, randomized, multicentre study investigated the efficacy and safety of two tacrolimus-based regimens and their potential to withdraw steroids. METHODS: In total 489 patients were randomised to receive either tacrolimus and MMF (n = 243) or tacrolimus and azathioprine (n = 246) concomitantly with steroids in both treatment groups. The initial oral dose of tacrolimus was 0.2 mg/kg/day, MMF dose was 1 g/day, azathioprine was administered at 1-2 mg/day. Steroids were tapered from 20 mg/day to 5 mg/day. From month 3 onwards, steroids were withdrawn in patients who were free from steroid-resistant rejection and who had serum creatinine concentrations <160 mumol/L. Study duration was 6 months. RESULTS: Patient survival at month 6 was 98.3% (Tac/MMF/S) and 98.4% (Tac/Aza/S), graft survival at 6 month was 95.0% (Tac/MMF/S) and 93.5% (Tac/Aza/S). The 6-month incidences of biopsy-proven acute rejection were 18.9% (Tac/MMF/S) compared with 26.8% (Tac/Aza/S), p = 0.038. The 6-month incidences of steroid-resistant acute rejection were 2.1% (Tac/MMF/S) and 4.9% (Tac/Aza/S), p = ns. At the end of month 3, steroid withdrawal was performed in 60.5% (Tac/MMF/S) and 48.8% (Tac/Aza/S) of patients, p <0.01. During months 4-6, 2.7% of patients in the Tac/MMF group had a biopsy-confirmed acute rejection compared with 0.8% of patients in the Tac/Aza group. In patients who continued to receive steroids, the incidences of biopsy-proven acute rejections during months 4-6 were 3.5% (Tac/MMF/S) and 7.1% (Tac/Aza/S). At study end, the steroid-free patients had an excellent kidney function, the median serum creatinine concentration was 119.5 mumol/L (Tac/MMF) and 115.1 mumol/L (Tac/Aza); the median serum creatinine of the total study group was 130.5 mumol/L (Tac/MMF/S) and 132.8 mumol/L (Tac/Aza/S). CONCLUSION: Both tacrolimus regimens are efficacious and safe. The combination of Tacrolimus and MMF achieved a lower rejection rate and permitted a higher proportion of steroid-free patients. The overall incidence of acute rejection was low and kidney function was good.

AB - OBJECTIVES: This prospective, randomized, multicentre study investigated the efficacy and safety of two tacrolimus-based regimens and their potential to withdraw steroids. METHODS: In total 489 patients were randomised to receive either tacrolimus and MMF (n = 243) or tacrolimus and azathioprine (n = 246) concomitantly with steroids in both treatment groups. The initial oral dose of tacrolimus was 0.2 mg/kg/day, MMF dose was 1 g/day, azathioprine was administered at 1-2 mg/day. Steroids were tapered from 20 mg/day to 5 mg/day. From month 3 onwards, steroids were withdrawn in patients who were free from steroid-resistant rejection and who had serum creatinine concentrations <160 mumol/L. Study duration was 6 months. RESULTS: Patient survival at month 6 was 98.3% (Tac/MMF/S) and 98.4% (Tac/Aza/S), graft survival at 6 month was 95.0% (Tac/MMF/S) and 93.5% (Tac/Aza/S). The 6-month incidences of biopsy-proven acute rejection were 18.9% (Tac/MMF/S) compared with 26.8% (Tac/Aza/S), p = 0.038. The 6-month incidences of steroid-resistant acute rejection were 2.1% (Tac/MMF/S) and 4.9% (Tac/Aza/S), p = ns. At the end of month 3, steroid withdrawal was performed in 60.5% (Tac/MMF/S) and 48.8% (Tac/Aza/S) of patients, p <0.01. During months 4-6, 2.7% of patients in the Tac/MMF group had a biopsy-confirmed acute rejection compared with 0.8% of patients in the Tac/Aza group. In patients who continued to receive steroids, the incidences of biopsy-proven acute rejections during months 4-6 were 3.5% (Tac/MMF/S) and 7.1% (Tac/Aza/S). At study end, the steroid-free patients had an excellent kidney function, the median serum creatinine concentration was 119.5 mumol/L (Tac/MMF) and 115.1 mumol/L (Tac/Aza); the median serum creatinine of the total study group was 130.5 mumol/L (Tac/MMF/S) and 132.8 mumol/L (Tac/Aza/S). CONCLUSION: Both tacrolimus regimens are efficacious and safe. The combination of Tacrolimus and MMF achieved a lower rejection rate and permitted a higher proportion of steroid-free patients. The overall incidence of acute rejection was low and kidney function was good.

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