Discontinuation of mycophenolate mofetil from a tacrolimus-based triple regimen 2 months after renal transplantation: a comparative randomized multicentre study

  1. Władysław Sułowicz1,
  2. Petr Bachleda2,
  3. Andrzej Rydzewski3,
  4. Bolesław Rutkowski4,
  5. Péter Szakály5,
  6. Lászlo Asztalos6,
  7. Jiři Samlik7,
  8. Eva Lacková8,
  9. Andrzej Ksia˛żek9,
  10. Pavel Studenik10,
  11. Michał Myśliwiec11,
  12. Zbigniew Hruby12,
  13. Pavel Navrátil13,
  14. Janusz Gumprecht14

Article first published online: 28 NOV 2006

DOI: 10.1111/j.1432-2277.2006.00421.x

Issue

Transplant International

Transplant International

Volume 20, Issue 3, pages 230–237, March 2007

Additional Information

How to Cite

Sułowicz, W., Bachleda, P., Rydzewski, A., Rutkowski, B., Szakály, P., Asztalos, L., Samlik, J., Lacková, E., Ksia˛żek, A., Studenik, P., Myśliwiec, M., Hruby, Z., Navrátil, P. and Gumprecht, J. (2007), Discontinuation of mycophenolate mofetil from a tacrolimus-based triple regimen 2 months after renal transplantation: a comparative randomized multicentre study. Transplant International, 20: 230–237. doi: 10.1111/j.1432-2277.2006.00421.x

Author Information

  1. 1

     Department of Nephrology, Collegium Medicum of Jagiellonian University, Kraków, Poland

  2. 2

     Transplant Centre, FN a LF UP Olomouc, Olomouc, Czech Republic

  3. 3

     Internal Diseases and Nephrology Department, Centralny Szpital Kliniczny MSWiA, Warszawa, Poland

  4. 4

     Department of Nephrology, Medical University of Gdańsk, Samodzielny Publiczny Szpital Kliniczny Nr 1, Gdańsk, Poland

  5. 5

     POTE, 1. Surgery Clinic, Pécs, Hungary

  6. 6

     Surgery Clinic, Transplantation Ward, Debrecen, Hungary

  7. 7

     Transplant Centre, FNsP Ostrava, Ostrava, Czech Republic

  8. 8

     Transplant Centre, NsP F.D. Roosevelta, Banská Bystrica, Slovakia

  9. 9

     Department of Nephrology, Samodzielny Publiczny Szpital Kliniczny Nr 4, Lublin, Poland

  10. 10

     Transplant Department, CKTCH, University Hospital St Ann, Brno, Czech Republic

  11. 11

     Nephrology Department, Wojewódzki Szpital Specjalistyczny, Białystok, Poland

  12. 12

     Internal-Nephrology Department, Wojewódzki Szpital Specjalistyczny, Wrocław, Poland

  13. 13

     Faculty Hospital, Hradec Králové, Urology Department, Hradec Králové, Czech Republic

  14. 14

     Department of Internal Diseases, Diabetics and Nephrology, Samodzielny Publiczny Szpital Kliniczny Nr 1, Zabrze, Poland

*Prof. Władysław Sułowicz, Oddział Kliniczny Kliniki Nefrologii, Szpital Uniwersytecki, ul. Kopernika 15C, 31-501 Kraków, Poland. Tel.: +48 12 4247800; fax: +48 12 4247149; e-mail: wladsul@mp.pl

Publication History

  1. Issue published online: 28 NOV 2006
  2. Article first published online: 28 NOV 2006
  3. Received: 18 May 2006 Revision requested: 7 June 2006 Accepted: 17 October 2006

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Keywords:

  • immunosuppression;
  • mycophenolate mofetil;
  • renal transplantation;
  • tacrolimus

Summary

Previous clinical data suggested that with a tacrolimus-based regimen adjunctive immunosuppressives may be withdrawn after an initial treatment period. This study investigated the early discontinuation of mycophenolate mofetil (MMF) from a standard triple regimen. Patients were randomized either to receive a continued tacrolimus/MMF/steroids triple regimen (control group) or to reduce and then stop the MMF dose (MMF stop group). Both groups received identical daily tacrolimus and corticosteroid doses. The initial MMF dose was 1 g/day in both arms, but in the MMF stop group the dose was reduced to 0.5 g/day from week 7 to week 12 and then stopped. The intent-to-treat population consisted of 74 (control) and 78 (MMF stop) patients. MMF was tapered off as planned in 82.9% of the patients in the MMF stop arm. The 6-month incidence of biopsy-proven acute rejection was similar in both arms (21.6% control, 16.7% MMF stop). Graft loss occurred in 5.4% (control) and 3.8% (MMF stop) of the patients. MMF could be safely discontinued from a tacrolimus-based triple therapy early after transplantation without any rebound in efficacy during the 6-month follow-up period.

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