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Multicenter, Randomized Study of the Use of Everolimus With Tacrolimus After Renal Transplantation Demonstrates its Effectiveness.

Author(s): Chan L, Greenstein S, Hardy MA, Hartmann E, Bunnapradist S, Cibrik D, Shaw LM, Munir L, Ulbricht B, Cooper M, for the CRADUS09 Study Group

Affiliation(s): 1 Health Sciences Center, University of Colorado, Denver, CO. 2 Montefiore Medical Center, Bronx, NY. 3 Columbia NY Presbyterian Hospital, New York, NY. 4 Wake Forest University Baptist Medical Center, Winston-Salem, NC. 5 University of California Los Angeles, Los Angeles, CA 90095. 6 University of Michigan, Ann Arbor, MI. 7 University of Pennsylvania, Philadelphia, PA. 8 Novartis Pharmaceuticals Corporation, East Hanover, NJ. 9 University of Maryland Medical System, Baltimore, MD.

Publication date & source: 2008-03-27, Transplantation., 85(6):821-826.

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 mumol/L (1.26+/-0.35 mg/dL) and 127+/-50 mumol/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.

Page last updated: 2008-03-26

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