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Transplantation. 2008 Mar 27;85(6):821-6. doi: 10.1097/TP.0b013e318166927b.

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

Author information

1
Health Sciences Center, University of Colorado, Denver, CO 80262, USA. larry.chan@uchsc.edu

Abstract

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.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT00170833.

PMID:
18360262
DOI:
10.1097/TP.0b013e318166927b
[Indexed for MEDLINE]
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