Folic Acid for Vascular Outcome Reduction in Transplantation (FAVORIT) Trial

描述（由申请人提供）： FAVORIT试验有几个设计特征，可以增强其解决降低总同型半胱氨酸（tHcy）浓度是否可以降低慢性肾脏病（CKD）患者CVD风险的能力。按照目前每月152例随机化的3个月速率，FAVORIT将在2007年1月31日的目标截止日期内完成入组。（n=4000;截至2006年7月5日招募了3621例患者）是迄今为止最大的一项试验，我们的目标是计划随访时间至2011年6月，是最长的，初步筛选数据表明，FAVIORIT的基线tHcy水平高于在非肾脏疾病人群中进行的试验。假设对照组中CVD的预计FAVORIT事件发生率发生，则试验将保持良好的把握度（即，0.87），以辨别积极降低tHcy治疗的事件（如果实现）中度减少20%。FAVORIT试验提供了一个独特的机会，可以在基线时和在4.5至9年的拟议随访期间每年从一个稳定的肾移植受者的大型队列中获得生物标本。已获得适当的同意，可将标本用于辅助研究，许多标本已转移到NIDDK标本储存库。为了用于辅助研究，将采集以下标本类型：EDTA血浆、血沉棕黄层、红细胞、血清、柠檬酸钠血浆和尿液。这些标本有条形码“ID”标签，没有任何个人标识符。无论FAVORIT中降低tHcy的干预是否显著降低CVD事件发生率，监测4000例慢性稳定肾移植受者的试验队列，从最短4.5年到最长9年的随访，将提供该患者人群中动脉粥样硬化CVD结局和（潜在）既往CVD风险因素的独特数据。正在审查的补充辅助研究将进一步阐明初始肾功能和白蛋白尿程度之间的相互关系，和/或这些参数的连续变化，以及FAVORIT队列中肾脏和CVD结局。一项正在进行的NIH资助的FAVORIT辅助研究（R 01 DK 65114 -03“FAVORIT辅助认知试验[FACT]”）已经提供了关于慢性肾移植患者认知功能和影响的前所未有的数据。

DESCRIPTION (provided by applicant): The FAVORIT trial has several design features that enhance its ability to address the question of whether lowering total homocysteine (tHcy) concentrations can reduce the risk of CVD among patients with chronic kidney disease (CKD). At the current three month rate of 152 randomizations per month FAVORIT will complete enrollment well within the target deadline of January 31, 2007 The sample size (n=4000; n=3621 recruited as of July 5, 2006) is the largest to date for a trial with our objective, the planned follow-up time through June 2011, is the longest, and preliminary screening data suggest baseline tHcy levels are higher in FAVIORIT than in trials conducted among non-renal disease populations. Assuming the projected FAVORIT event rate for CVD among controls occurs, the trial will remain well-powered (i.e., 0.87) to discern a moderate 20% reduction in events (if achieved) with active tHcy-lowering treatment. The FAVORIT trial provides a unique opportunity to obtain biologic specimens on a large cohort of stable kidney transplant recipients at baseline and annually throughout 4.5 to 9 years of proposed follow-up. Appropriate consent has been obtained to make specimens available for ancillary studies and many of the specimens have already been transferred to the NIDDK Specimen Repository. For use in ancillary studies, the following specimen types are being collected: EDTA plasma, buffy coat, red blood cells, serum, sodium citrate plasma, and urine. These specimens have bar-coded' ID labels without any personal identifiers. Regardless of whether or not the tHcy-lowering intervention in FAVORIT significantly reduces CVD event rates, monitoring the trial cohort of 4000 chronic stable renal transplant recipients, ranging from a minimum follow-up of 4.5 years, to a maximum of 9 years, will provide unique data on arteriosclerotic CVD outcomes, and (potential) antecedent CVD risk factors, in this patient population. Complementary ancillary studies under review will further address the interrelationships between initial renal function and degree of albuminuria, and/or serial changes in these parameters, with both renal and CVD outcomes in the FAVORIT cohort. An ongoing NIH-funded FAVORIT ancillary study (R01 DK65114-03 "FAVORIT Ancillary Cognitive Trial [FACT]" is already providing unprecedented data on cognitive function and affect in chronic renal transplantation.