Use of 12-Month Renal Function and Baseline Clinical Factors to Predict Long-Term Graft Survival: Application to BENEFIT and BENEFIT-EXT Trials
Use of 12-Month Renal Function and Baseline Clinical Factors to Predict Long-Term Graft Survival: Application to BENEFIT and BENEFIT-EXT Trials
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DOI：
10.1097/tp.0b013e31823ec02a
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发表时间：
2012-01-27
期刊：
影响因子：
6.2
通讯作者：
L'Italien, Gilbert
中科院分区：
文献类型：
--
作者：
Schnitzler, Mark A.;Lentine, Krista L.;L'Italien, Gilbert
背景肾移植管理的创新将受益于早期标志物的识别，准确预测长期移植物存活。分析了来自美国肾脏数据系统的肾移植受者数据（1995-2004），以根据估计的肾小球滤过率（eGFR）、1年内是否存在急性排斥反应以及受者和供体的人口统计学特征建立全因移植物存活的预测模型。将预测模型应用于Belatacept Evaluation of Nephroprotection and Effectiveness as First-line Immunosuppression Trial和Belatacept Evaluation of Nephroprotection and Effectiveness as First-line Immunosuppression Trial-EXTended criteria donors试验中的参与者，分别在标准标准供体（SCD）和扩展标准供体（ECD）移植受体中比较Belatacept与环孢素，作为模型预测在不同人群中的外部验证。与eGFR <60 mL/min/1.73 m（2）相比，eGFR <15 mL/min/1.73 m（2）的SCD和ECD受者中，全因移植物丢失的相对风险以加速模式增加，GFR较低，分别约为8倍和7倍（2）。当应用于临床试验样本时，在移植第二周年时，低强度贝拉西普与环孢霉素的全因移植物存活率的预测差异（SCD：3.9%，95%置信区间[CI]：3.6%-4.2%; ECD：4.1%，95% CI：3.5%-4.7%）与观察到的差异相似（SCD：4.2%，97.3%CI：-1.3%to 10. 1%; ECD：1.4%，97.3%CI：-7.5%to 10. 2%）。移植物长期存活的精确模型可以通过eGFR、供体和受体特征来建立。长期生存预测模型可以提供一种有效的方法来评估新的药物和临床管理协议的影响。
Background. Innovation in renal transplant management would benefit from identification of early markers that accurately predict long-term graft survival.Methods. Data from the United States Renal Data System for kidney transplant recipients (1995-2004) were analyzed to develop prediction models for all-cause graft survival based on estimated glomerular filtration rate (eGFR), the presence or absence of acute rejection within 1 year, and recipient and donor demographic characteristics. The prediction models were applied to participants in the Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression Trial and Belatacept Evaluation of Nephroprotection and Efficacy as First-line Immunosuppression Trial-EXTended criteria donors trials comparing belatacept with cyclosporine in standard criteria donor (SCD) and expanded criteria donor (ECD) graft recipients, respectively, as an external validation of the model predictions in a diverse population.Results. Compared with eGFR 60 mL/min/1.73 m(2), the relative hazard for all-cause graft loss increased in an accelerating pattern with lower GFR to approximately eight and seven times, respectively, among SCD and ECD recipients with eGFR less than 15 mL/min/1.73 m(2). When applied to the clinical trial samples, the predicted differences in all-cause graft survival of less intensive belatacept versus cyclosporine at the second transplant anniversary (SCD: 3.9%, 95% confidence interval [CI]: 3.6% to 4.2%; ECD: 4.1%, 95% CI: 3.5% to 4.7%) were similar to observed differences (SCD: 4.2%, 97.3% CI: -1.3% to 10.1%; ECD: 1.4%, 97.3% CI: -7.5% to 10.2%).Conclusions. Accurate models of long-term graft survival can be developed using eGFR, donor, and recipient characteristics. Long-term survival prediction models may provide an efficient method for assessing the impact of novel pharmaceutical agents and clinical management protocols.