NDT Advance Access originally published online on August 10, 2004
Nephrology Dialysis Transplantation 2004 19(10):2630-2633; doi:10.1093/ndt/gfh446
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Nephrol Dial Transplant Vol. 19 No. 10 © ERA-EDTA 2004; all rights reserved
Brief Report
The effect of sevelamer on the pharmacokinetics of cyclosporin A and mycophenolate mofetil after renal transplantation
1 Department of Pediatric Nephrology, 2 Department of Clinical Pharmacology and 3 Department of Nephrology, Charité, Humboldt University, Berlin, Germany
Correspondence and offprint requests to: Anne-Kathrin Pieper, MD, Department of Pediatric Nephrology, Charité Campus Virchow, Augustenburger Platz 1, D-13353 Berlin, Germany. Email: anne-kathrin.pieper{at}charite.de
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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