Multicenter, Randomized Study of the Use of Everolimus With Tacrolimus After Renal Transplantation Demonstrates its Effectiveness
| Autor: | Laurence, Chan, Stuart, Greenstein, Mark A, Hardy, Erica, Hartmann, Suphamai, Bunnapradist, Diane, Cibrik, Leslie M, Shaw, Laura, Munir, Bettina, Ulbricht, Matthew, Cooper, Radi F, Zaki |
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| Rok vydání: | 2008 |
| Předmět: |
Adult
Male medicine.medical_specialty Basiliximab Urology Renal function chemical and pharmacologic phenomena Tacrolimus chemistry.chemical_compound Living Donors medicine Humans Everolimus Kidney transplantation Sirolimus Transplantation Creatinine business.industry Middle Aged medicine.disease Kidney Transplantation Tissue Donors Surgery Calcineurin surgical procedures operative chemistry Kidney Failure Chronic Drug Therapy Combination Female business Immunosuppressive Agents medicine.drug |
| Zdroj: | Transplantation. 85:821-826 |
| ISSN: | 0041-1337 |
| DOI: | 10.1097/tp.0b013e318166927b |
| Popis: | 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: | OpenAIRE |
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