Division of Transplant Surgery, Medical University of South Carolina, Charleston, South Carolina.
Department of Transplant, Mayo Clinic, Rochester, Minnesota.
Clin Transplant. 2019 Oct;33(10):e13679. doi: 10.1111/ctr.13679. Epub 2019 Sep 12.
This was a single-center, randomized controlled trial assessing the impact of a 3-month (10-16 weeks) conversion to everolimus with low-exposure tacrolimus, as compared to remaining on full exposure tacrolimus with mycophenolate (NCT02096107). Adult kidney transplant recipients with a functioning graft were eligible for participation. Goal troughs in the intervention arm were 2-5 ng/mL for tacrolimus and 3-8 ng/mL for everolimus, with tacrolimus maintained at 5-12 ng/mL in the control arm; 60 were randomized (30 in each arm) and were well matched at baseline; mean age was 51 years and 57% were African-American. At 12-months, fibrosis scores (27.8% tacrolimus/mycophenolate vs 22.9% tacrolimus/everolimus, P = .391), acute rejection rates (7% tacrolimus/mycophenolate vs 3% tacrolimus/everolimus, P = .554), and graft function (mean eGFR tacrolimus/mycophenolate 56 ± 15 vs tacrolimus/everolimus 59 ± 14 mL/min/1.73 m , P = .465) were similar between arms. The everolimus arm had significantly lower rates of CMV infection, severe BK infection, and improved BK viral clearance kinetics, as compared to the MPA arm. In this population, including a significant number of African-Americans, an immunosuppression regimen of everolimus with low-exposure tacrolimus provided similar efficacy to tacrolimus and mycophenolate, with significantly lower rates of BK and CMV.
这是一项单中心、随机对照试验，评估了将他克莫司转换为依维莫司（低暴露）并联合霉酚酸酯（MMF）治疗 3 个月（10-16 周）的影响，与继续使用全暴露他克莫司联合霉酚酸酯的治疗方案相比（NCT02096107）。纳入的研究对象为移植肾功能正常的成年肾移植受者。干预组他克莫司的目标谷浓度为 2-5ng/mL，依维莫司为 3-8ng/mL，对照组他克莫司的目标谷浓度为 5-12ng/mL；60 名患者随机分组（每组 30 名），基线时两组患者匹配良好；平均年龄为 51 岁，57%为非裔美国人。12 个月时，纤维化评分（他克莫司/霉酚酸酯组 27.8% vs 他克莫司/依维莫司组 22.9%，P=0.391）、急性排斥反应发生率（他克莫司/霉酚酸酯组 7% vs 他克莫司/依维莫司组 3%，P=0.554）和移植肾功能（他克莫司/霉酚酸酯组 eGFR 平均为 56±15 vs 他克莫司/依维莫司组 59±14mL/min/1.73m2，P=0.465）在两组间无显著差异。与 MMF 组相比，依维莫司组的 CMV 感染、严重 BK 感染发生率更低，BK 病毒清除动力学改善。在该人群中，包括相当数量的非裔美国人，依维莫司联合低暴露他克莫司的免疫抑制方案与他克莫司联合霉酚酸酯的疗效相当，但 BK 和 CMV 的发生率显著降低。
