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Sirolimus Does Not Exhibit Nephrotoxicity Compared to Cyclosporine in Renal Transplant Recipients

  1. José M. Morales1,
  2. Lars Wramner2,
  3. Henri Kreis3,
  4. Dominique Durand4,
  5. Josep M. Campistol5,
  6. Amado Andres1,
  7. Joaquin Arenas1,
  8. Eric Nègre6,
  9. James T. Burke6,
  10. Carl G. Groth7,
  11. Sirolimus European Renal Transplant Study Group†

Article first published online: 23 MAY 2002

DOI: 10.1034/j.1600-6143.2002.20507.x

Issue

American Journal of Transplantation

American Journal of Transplantation

Volume 2, Issue 5, pages 436–442, May 2002

Additional Information

How to Cite

Morales, J. M., Wramner, L., Kreis, H., Durand, D., Campistol, J. M., Andres, A., Arenas, J., Nègre, E., Burke, J. T., Groth, C. G. and Sirolimus European Renal Transplant Study Group (2002), Sirolimus Does Not Exhibit Nephrotoxicity Compared to Cyclosporine in Renal Transplant Recipients. American Journal of Transplantation, 2: 436–442. doi: 10.1034/j.1600-6143.2002.20507.x

Author Information

  1. 1

    Hospital 12 de Octubre, Madrid, Spain

  2. 2

    Salgrenska University Hospital, Göteborg, Sweden

  3. 3

    Hôpital Necker, Paris, France

  4. 4

    CHU Rangueil, Toulouse, France

  5. 5

    Hospital Clinic I Provincial, Barcelona, Spain

  6. 6

    Wyeth-Ayerst Research, Paris, France

  7. 7

    Huddinge Hospital, Stockholm, Sweden

  1. †

    * Other members of the Sirolimus European Renal Transplant Study Group: F.C. Berthoux (Hôpital Nord, Saint Etienne, France), P. Vialtel (Hôpital Albert Michalon, Grenoble, France), G. Mourad (CHU Lapeyronie, Montpellier, France), J.M. Grinyo (Hospital Bellvitge, Barcelona, Spain), R. Calne and C. Watson (Addenbrooke's Hospital, Cambridge, United Kingdom), P. Lang (Hôpital Henri Mondor, Créteil, France), J.L. Touraine (Hôpital Edouard Herriot, Lyon, France), K. Claesson (University Hospital, Uppsala, Sweden), B. Charpentier (Hôpital de Bicêtre, Kremlin Bicêtre, France), C. Brattström (Huddinge Hospital, Stockholm, Sweden), D. Abramowicz (Hôpital Erasme, Brussels, Belgium), J.P. Squifflet (Clinique Universitaire St. Luc, Brussels, Belgium), Y. Lebranchu (CHU Tours, Tours, France), W. Land (University of Munich, Munich, Germany).

** Corresponding author: José M. Morales, jmorales@h120.es

  • †

    * Other members of the Sirolimus European Renal Transplant Study Group: F.C. Berthoux (Hôpital Nord, Saint Etienne, France), P. Vialtel (Hôpital Albert Michalon, Grenoble, France), G. Mourad (CHU Lapeyronie, Montpellier, France), J.M. Grinyo (Hospital Bellvitge, Barcelona, Spain), R. Calne and C. Watson (Addenbrooke's Hospital, Cambridge, United Kingdom), P. Lang (Hôpital Henri Mondor, Créteil, France), J.L. Touraine (Hôpital Edouard Herriot, Lyon, France), K. Claesson (University Hospital, Uppsala, Sweden), B. Charpentier (Hôpital de Bicêtre, Kremlin Bicêtre, France), C. Brattström (Huddinge Hospital, Stockholm, Sweden), D. Abramowicz (Hôpital Erasme, Brussels, Belgium), J.P. Squifflet (Clinique Universitaire St. Luc, Brussels, Belgium), Y. Lebranchu (CHU Tours, Tours, France), W. Land (University of Munich, Munich, Germany).

Publication History

  1. Issue published online: 23 MAY 2002
  2. Article first published online: 23 MAY 2002
  3. Received 29 June 2001,revised and accepted for publication 17 December 2001

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Keywords:

  • Cyclosporine;
  • nephrotoxicity;
  • renal function;
  • renal transplantation;
  • sirolimus

Sirolimus and cyclosporine (CsA) prevent acute rejection in man when used as primary therapies in triple drug regimens. Sirolimus does not act via the calcineurin pathway and therefore is not expected to produce the same renal side-effects. This paper presents the pooled 2-year data analysis of renal function parameters from two open-label, randomized, multicenter studies. Patients (18–68 years) receiving a primary renal allograft were randomized to receive concentration-controlled sirolimus (n = 81) or CsA (n = 80), in combination with azathioprine and steroids (n = 83), or mycophenolate mofetil (MMF) and steroids (n = 78). From week 10 through year 2, calculated glomerular filtration rate (GFR) was significantly higher in sirolimus- than in CsA-treated patients (69.3 vs. 56.8 mL/min, at 2 years, p = 0.004). Serum uric acid was significantly higher in the CsA-treated patients and magnesium was significantly lower; these parameters were more likely to be within normal limits in the sirolimus group. Mean serum potassium and phosphorus were lower in sirolimus-treated patients. In conclusion, sirolimus, when administered as primary therapy in combination with azathioprine or MMF, has a favorable safety profile compared to CsA with regards to renal function.

View Full Article (HTML) Get PDF (120K)