4.5 Article

Evaluation of the efficacy and safety of a slow conversion from calcineurin inhibitor- to sirolimus-based therapies in maintenance renal-transplant patients presenting with moderate renal insufficiency

期刊

TRANSPLANT INTERNATIONAL
卷 20, 期 2, 页码 128-134

出版社

WILEY
DOI: 10.1111/j.1432-2277.2006.00409.x

关键词

calcineurin inhibitor; kidney transplantation; lipids; microcytic anemia; renal insufficiency; sirolimus

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This prospective study assesses over a period of 6 months, the variations in glomerular filtration rate (GFR) and safety parameters within a cohort of 44 cadaveric renal-transplant (RT) patients presenting with moderate renal insufficiency. They were progressively switched from calcineurin inhibitors (CNIs) based- to sirolimus (SRL) based-therapies aiming SRL troughs at levels similar to 8 ng/ml (range 6-10). All the patients were receiving in addition mycophenolate mofetil. The intent-to-treat (ITT) patient and graft survivals were 100%. Thirty-four patients, i.e. 77.3% completed the study. Overall, there was a significant improvement in the calculated GFR (Nankivell formula) from day 0 to month 6, i.e. from 45.98 (+/- 16.3) to 53.07 (+/- 12.68) ml/mn (P = 0.03). However, renal function improved in only 20 cases (group I), and deteriorated in the others (group II). Groups I and II did not significantly differ with respect to time between transplantation and drug switch, GFR, serum creatinine, and proteinuria at baseline. There was only one case of steroid-sensitive acute rejection. Overall, there was a significant increase in proteinuria from 0 (0-3.15) to 0.57 (0-4.85) g/day (P = 0.002). Finally, the conversion was associated with a significant increase in lipids, and a significant decrease in hemoglobin levels.

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