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• W1995604619 abstract "P218 Aims: Certican® (everolimus) is a proliferation signal inhibitor effective for the prevention of rejection in de novo renal and heart transplants in combination with full-dose Neoral®. In this study, safety and efficacy of Certican® were assessed with reduced exposure of Neoral® by evaluation of creatinine clearance and quantification of the incidence of biopsy-proven acute rejections, graft loss, death or lost to follow-up. Methods: This was a randomized, open label, multicenter trial, using concentration-controlled everolimus, to reach everolimus blood trough levels ≥3ng/mL. Subjects (N=237) were randomized to either Certican® 1.5 mg/day (N=112) or 3 mg/day (N=125), combined with steroids and reduced exposure of Neoral® (cyclosporine for microemulsion). Neoral® was tapered using C2-monitoring: 1200 ng/ml (week 0-4), 800 ng/ml (week 5-8), 600 ng/ml (week 9-12) and 400 ng/ml (month 4-12). Results: On-treatment renal function at 12 months was comparable between both treatment arms with a mean (median) serum creatinine of 126 (122) μmol/L in the Certican® 1.5 mg group and 134 (126) μmol/L in the Certican® 3 mg group. The mean (median) serum creatinine levels in the 12 month ITT analysis were 140 (131) μmol/L and 137 (130) μmol/L in the 1.5 mg and the 3 mg group, respectively. Mean (median) creatinine clearance (Cockcroft-Gault) was 65 (65) mL/min and 64 (63) mL/min (ITT-analysis). CMV infections were reported in 0.9% and 4.0% of the patients, respectively. Mean cholesterol levels were 6.3 and 6.2 mmol/L and mean triglyceride levels were 2.5 and 3.0 mmol/L in the two groups. Hypercholesterolemia (13% and 23%) and thrombocytopenia (4% and 8%) were lower in the 1.5 mg Certican® group. The incidence of primary efficacy failure (biopsy-proven acute rejection, graft loss, death or loss to follow-up) was comparable between Certican® 1.5 mg and Certican® 3 mg groups (28% and 26%, p=NS), as was the incidence of biopsy-proven acute rejection (26% and 19%, p=NS) Conclusions: With this regimen of Certican® and reduced exposure of Neoral®, the renal function was stable through 12 months, and compared favourably to the historical trial findings with Certican® and full dose Neoral®. Despite significant reduction of Neoral® exposure, good efficacy was maintained. This regimen appears to optimize Certican®, Neoral® and steroid combination therapy in de novo kidney transplantation." @default.
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• W1995604619 date "2004-07-01" @default.
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• W1995604619 title "12 MONTH CLINICAL TRIAL RESULTS OF SAFETY AND EFFICACY OF TROUGH-CONTROLLED CERTICAN® DOSING WITH REDUCED NEORAL® EXPOSURE IN DE NOVO KIDNEY TRANSPLANT RECIPIENTS" @default.
• W1995604619 doi "https://doi.org/10.1097/00007890-200407271-00713" @default.
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