Pilot Randomized Study of Early Tacrolimus Withdrawal from a Regimen with Sirolimus Plus Tacrolimus in Kidney Transplantation

来自 Wiley

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作者：

JM Grinyo，JM Campistol，J Paul，Javier García㎝artínez，JM Morales，D Prats，M Arias，M Brunet，J Cabrera，E Granados

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摘要：

We performed a randomized trial to compare two regimens of low-risk kidney allograft recipients in the first year after transplantation. Both regimens initially included sirolimus, tacrolimus and steroids; one with long-term maintenance with these drugs vs. tacrolimus withdrawal. Group I: sirolimus levels of 4–8 ng/mL, plus tacrolimus 8–12 ng/mL for 3 months, and 5–10 ng/mL after month 3. Group II: sirolimus concentration of 8–16 ng/mL, plus tacrolimus 3–8 ng/mL with tacrolimus elimination from month 3 onwards. Owing to difficulties in achieving target levels, the protocol was amended to increase the doses. Eighty-seven patients were recruited. In the intention-to-treat analysis, glomerular filtration rate (GFR) at 12 months, adjusted to zero for graft loss, was similar in both groups (58.8 and 59.9 mL/min). Analysis of patients remaining on protocol showed that GFR was higher in group II only in the patients postamendment (58.4 and 72.9 mL/min, p = 0.03).

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关键词：

Kidney transplantation sirolimus tacrolimus

DOI：

10.1111/j.1600-6143.2004.00499.x

被引量：

126

年份：

2004