Tacrolimus combined with two different corticosteroid-free regimens compared with a standard triple regimen in renal transplantation

One year observational results

Bernhard K. Krämer, Marian Klinger, Zbigniew Wlodarczyk, Marek Ostrowski, Karsten Midvedt, Sergio Stefoni, Franco Citterio, Frank Pietruck, Jean Paul Squifflet, Giuseppe Segoloni, Bernd Krüger, Heide Sperschneider, Bernhard Banas, Lars Bäckman, Markus Weber, Mario Carmellini, F. Perner, Kerstin Claesson, Wojciech Marcinkowski, Štefan Vítko & 3 others Grzegorz Senatorski, Kaija Salmela, Johan Nordström

Research output: Contribution to journalArticle

7 Citations (Scopus)

Abstract

Side effects of steroid use have led to efforts to minimize their use in transplantation. Two corticosteroid-free regimens were compared with a triple immunosuppressive therapy. Data from the original intent-to-treat (ITT) population (153 tacrolimus/basiliximab [Tac/Bas], 151 tacrolimus/MMF [Tac/MMF], and 147 tacrolimus/MMF/steroids [control]) were analyzed in a 12-month follow-up. Percentage of graft survival were 92.8%, 95.4%, and 95.9% (KM estimates 89.9%, 95.3%, 95.9%), percentage of surviving patients were 98.7%, 98.0%, and 100% (KM estimates 95.9%, 92.8%, and 100%). During months 7-12, graft loss occurred in 3 Tac/Bas, 2 Tac/MMF, and zero control patients, patient deaths in 1 Tac/Bas, 2 Tac/MMF, and zero control, and biopsy-proven acute rejection episodes in 4 Tac/Bas, 3 Tac/MMF, and zero control. Mean serum creatinine at month 12 was 141.9 ± 69.6 μM, 144.0 ± 82.1 μM, and 134.5 ± 71.2 μM (ns). New-onset insulin use in previously non-diabetic patients at month 12 was 1/138, 6/127, and 4/126. Patient and graft survival as well as renal function at 12 months were not different between patient groups, despite considerably higher rates of acute rejection occurring within the first six months after transplantation in both steroid-free patient groups. Tac/Bas therapy might offer benefits in terms of a trend for a more favorable cardiovascular risk profile.

Original languageEnglish
JournalClinical Transplantation
Volume24
Issue number1
DOIs
Publication statusPublished - Jan 2010

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Tacrolimus
Kidney Transplantation
Adrenal Cortex Hormones
Steroids
Graft Survival
Transplantation
Immunosuppressive Agents
Creatinine
basiliximab
Insulin
Transplants
Kidney
Biopsy

Keywords

  • Basiliximab
  • Corticosteroid withdrawal
  • Mycophenolate mofetil
  • Renal transplantation
  • Tacrolimus

ASJC Scopus subject areas

  • Transplantation

Cite this

Tacrolimus combined with two different corticosteroid-free regimens compared with a standard triple regimen in renal transplantation : One year observational results. / Krämer, Bernhard K.; Klinger, Marian; Wlodarczyk, Zbigniew; Ostrowski, Marek; Midvedt, Karsten; Stefoni, Sergio; Citterio, Franco; Pietruck, Frank; Squifflet, Jean Paul; Segoloni, Giuseppe; Krüger, Bernd; Sperschneider, Heide; Banas, Bernhard; Bäckman, Lars; Weber, Markus; Carmellini, Mario; Perner, F.; Claesson, Kerstin; Marcinkowski, Wojciech; Vítko, Štefan; Senatorski, Grzegorz; Salmela, Kaija; Nordström, Johan.

In: Clinical Transplantation, Vol. 24, No. 1, 01.2010.

Research output: Contribution to journalArticle

Krämer, BK, Klinger, M, Wlodarczyk, Z, Ostrowski, M, Midvedt, K, Stefoni, S, Citterio, F, Pietruck, F, Squifflet, JP, Segoloni, G, Krüger, B, Sperschneider, H, Banas, B, Bäckman, L, Weber, M, Carmellini, M, Perner, F, Claesson, K, Marcinkowski, W, Vítko, Š, Senatorski, G, Salmela, K & Nordström, J 2010, 'Tacrolimus combined with two different corticosteroid-free regimens compared with a standard triple regimen in renal transplantation: One year observational results', Clinical Transplantation, vol. 24, no. 1. https://doi.org/10.1111/j.1399-0012.2009.01162.x
Krämer, Bernhard K. ; Klinger, Marian ; Wlodarczyk, Zbigniew ; Ostrowski, Marek ; Midvedt, Karsten ; Stefoni, Sergio ; Citterio, Franco ; Pietruck, Frank ; Squifflet, Jean Paul ; Segoloni, Giuseppe ; Krüger, Bernd ; Sperschneider, Heide ; Banas, Bernhard ; Bäckman, Lars ; Weber, Markus ; Carmellini, Mario ; Perner, F. ; Claesson, Kerstin ; Marcinkowski, Wojciech ; Vítko, Štefan ; Senatorski, Grzegorz ; Salmela, Kaija ; Nordström, Johan. / Tacrolimus combined with two different corticosteroid-free regimens compared with a standard triple regimen in renal transplantation : One year observational results. In: Clinical Transplantation. 2010 ; Vol. 24, No. 1.
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