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NDT Advance Access published online on August 10, 2004
Nephrology Dialysis Transplantation, doi:10.1093/ndt/gfh446
© 2004 by European Renal Association - European Dialysis and Transplant Association
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Received October 23, 2003
Accepted June 2, 2004

Brief Report

The effect of sevelamer on the pharmacokinetics of cyclosporin A and mycophenolate mofetil after renal transplantation

Anne-Kathrin Pieper 1*, Franziska Buhle 1, Steffen Bauer 2, Ingrid Mai 2, Klemens Budde 3, Dieter Haffner 1, Hans-Hellmut Neumayer 3, Uwe Querfeld 1

1 Department of Pediatric Nephrology, Charité, Humboldt University, Berlin, Germany
2 Department of Clinical Pharmacology, Charité, Humboldt University, Berlin, Germany
3 Department of Nephrology, Charité, Humboldt University, Berlin, Germany

* To whom correspondence should be addressed. E-mail: anne-kathrin.pieper{at}charite.de.



  Abstract

Background. After renal transplantation, patients with insufficient graft function may require phosphate binders. It is still unknown if sevelamer, a new calcium-free phosphate binder, interferes with the uptake of immunosuppressants. We studied its effects on the pharmacokinetics of cyclosporin A (CsA) and mycophenolate mofetil.

Methods. We examined 10 adults and eight children with stable renal graft function and stable CsA trough levels. A 12 h pharmacokinetic profile (10 observation points) was conducted without sevelamer, after a single dose and after 4 days of treatment with it. CsA levels were measured with both a monoclonal antibody assay (CEDIA) and a polyclonal antibody assay (FPIA), mycophenolic acid (MPA) levels by EMIT assay and CsA metabolites AM1, AM9 and AM4N by a modified HPLC method.

Results. Sevelamer had no significant effect on CsA kinetics [area under the curve (AUC), peak concentration (Cmax), time of Cmax]. The AUC of AM1 was decreased by 30% and Cmax by 25% after 4 days of sevelamer intake. MPA levels were significantly reduced by a mean of 25% of the AUC (P<0.05) and by 30% of the Cmax after a single dose of sevelamer.

Conclusions. A single sevelamer dose reduces the Cmax and the AUC of MPA. Its intake for several days does not significantly influence CsA kinetics.

Keywords: cyclosporin A; interaction; mycophenolate mofetil; pharmacokinetics; sevelamer; transplantation.
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