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 receivedeverolimus, steroids, and basiliximab with low or standard tacrolimus exposure. The primary objective was to compare renal function at 6 months after transplant. RESULTS:Mean6-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.
RCT Entities:
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.
Authors: Angela C Webster; Lorenn P Ruster; Richard McGee; Sandra L Matheson; Gail Y Higgins; Narelle S Willis; Jeremy R Chapman; Jonathan C Craig Journal: Cochrane Database Syst Rev Date: 2010-01-20
Authors: Klemens Budde; Claudia Sommerer; Thomas Rath; Petra Reinke; Hermann Haller; Oliver Witzke; Barbara Suwelack; Daniel Baeumer; Christian Sieder; Martina Porstner; Wolfgang Arns Journal: J Nephrol Date: 2014-09-06 Impact factor: 4.393
Authors: Steven J Chadban; Josette Marie Eris; John Kanellis; Helen Pilmore; Po Chang Lee; Soo Kun Lim; Chad Woodcock; Nicol Kurstjens; Graeme Russ Journal: Transpl Int Date: 2014-01-06 Impact factor: 3.782
Authors: Claudia Sommerer; Barbara Suwelack; Duska Dragun; Peter Schenker; Ingeborg A Hauser; Björn Nashan; Friedrich Thaiss Journal: Trials Date: 2016-02-17 Impact factor: 2.279