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

Laurence Chan, Stuart M. Greenstein, Mark A. Hardy, Erica Hartmann, Suphamai Bunnapradist, Diane Cibrik, Leslie M. Shaw, Laura Munir, Bettina Ulbricht, Matthew Cooper

Research output: Contribution to journalArticle

91 Citations (Scopus)

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 μmol/L (1.26±0.35 mg/dL) and 127±50 μmol/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.

Original languageEnglish (US)
Pages (from-to)821-826
Number of pages6
JournalTransplantation
Volume85
Issue number6
DOIs
StatePublished - Mar 2008

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Tacrolimus
Kidney Transplantation
Multicenter Studies
Kidney
Transplants
Steroids
Everolimus
Creatinine
Arm
Biopsy
Safety
Serum

Keywords

  • Certican
  • Efficacy
  • Everolimus
  • Tacrolimus

ASJC Scopus subject areas

  • Transplantation
  • Immunology

Cite this

Multicenter, randomized study of the use of everolimus with tacrolimus after renal transplantation demonstrates its effectiveness. / Chan, Laurence; Greenstein, Stuart M.; Hardy, Mark A.; Hartmann, Erica; Bunnapradist, Suphamai; Cibrik, Diane; Shaw, Leslie M.; Munir, Laura; Ulbricht, Bettina; Cooper, Matthew.

In: Transplantation, Vol. 85, No. 6, 03.2008, p. 821-826.

Research output: Contribution to journalArticle

Chan, L, Greenstein, SM, Hardy, MA, Hartmann, E, Bunnapradist, S, Cibrik, D, Shaw, LM, Munir, L, Ulbricht, B & Cooper, M 2008, 'Multicenter, randomized study of the use of everolimus with tacrolimus after renal transplantation demonstrates its effectiveness', Transplantation, vol. 85, no. 6, pp. 821-826. https://doi.org/10.1097/TP.0b013e318166927b
Chan, Laurence ; Greenstein, Stuart M. ; Hardy, Mark A. ; Hartmann, Erica ; Bunnapradist, Suphamai ; Cibrik, Diane ; Shaw, Leslie M. ; Munir, Laura ; Ulbricht, Bettina ; Cooper, Matthew. / Multicenter, randomized study of the use of everolimus with tacrolimus after renal transplantation demonstrates its effectiveness. In: Transplantation. 2008 ; Vol. 85, No. 6. pp. 821-826.
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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 μmol/L (1.26±0.35 mg/dL) and 127±50 μmol/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.",
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T1 - Multicenter, randomized study of the use of everolimus with tacrolimus after renal transplantation demonstrates its effectiveness

AU - Chan, Laurence

AU - Greenstein, Stuart M.

AU - Hardy, Mark A.

AU - Hartmann, Erica

AU - Bunnapradist, Suphamai

AU - Cibrik, Diane

AU - Shaw, Leslie M.

AU - Munir, Laura

AU - Ulbricht, Bettina

AU - Cooper, Matthew

PY - 2008/3

Y1 - 2008/3

N2 - 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 μmol/L (1.26±0.35 mg/dL) and 127±50 μmol/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.

AB - 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 μmol/L (1.26±0.35 mg/dL) and 127±50 μmol/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.

KW - Certican

KW - Efficacy

KW - Everolimus

KW - Tacrolimus

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