Multicenter, randomized study of the use of everolimus with tacrolimus after renal transplantation demonstrates its effectiveness.

Autor:	Chan L; Health Sciences Center, University of Colorado, Denver, CO 80262, USA. larry.chan@uchsc.edu, Greenstein S, Hardy MA, Hartmann E, Bunnapradist S, Cibrik D, Shaw LM, Munir L, Ulbricht B, Cooper M
Jazyk:	angličtina
Zdroj:	Transplantation [Transplantation] 2008 Mar 27; Vol. 85 (6), pp. 821-6.
DOI:	10.1097/TP.0b013e318166927b
Abstrakt:	Background: Clinical data are lacking concerning concomitant administration of everolimus and tacrolimus in renal transplant recipients. Methods: In a prospective, multicenter, open-label, exploratory, randomized, 6-month study, 92 de novo renal transplant patients received everolimus, steroids, and basiliximab with low or standard tacrolimus exposure. The primary objective was to compare renal function at 6 months after transplant. Results: Mean 6-month serum creatinine (primary safety variable) was 112+/-31 micromol/L (1.26+/-0.35 mg/dL) and 127+/-50 micromol/L (1.44+/-0.57 mg/dL) in the low and standard tacrolimus groups, respectively, (n.s.); mean estimated GFR (Nankivell) was 75.3+/-16.6 mL/min and 72.5+/-15.2 mL/min (n.s.). Biopsy-proven acute rejection occurred in 13 patients: seven (14%) in the low tacrolimus group and six (14%) in the standard tacrolimus group, n.s. One graft was lost in the standard tacrolimus group. No patients died. Conclusions: Tacrolimus exposure reduction in the presence of everolimus, steroids and basiliximab induction results in good efficacy in de novo renal transplant recipients with very well-preserved renal function. Additional studies are warranted because between-group comparisons were limited by the relatively small differences in tacrolimus exposure in the 2 arms; trough levels were toward the upper end of the low-exposure ranges and toward the bottom of the standard-exposure ranges.
Databáze:	MEDLINE
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