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

Favorit试验有几个设计特点，增强了它解决以下问题的能力： 降低总同型半胱氨酸浓度可降低慢性阻塞性肺疾病患者心血管疾病的风险 肾病(CKD)。按照目前每月152次随机选择的三个月速度，Favorit将 在2007年1月31日的目标截止日期内很好地完成登记样本量(n=4000；n=3621 截至2006年7月5日招募)是迄今为止规模最大的一次试验，我们的目标是计划的后续时间 到2011年6月，是最长的，初步筛查数据表明，在 比在非肾脏疾病人群中进行的试验更受欢迎。假设预计的收藏量 在对照中发生心血管疾病的事件发生率，试验将保持良好的动力(即，0.87)以识别 主动降低tHcy治疗使事件减少20%(如果实现)。Favorit试验 为在一大批稳定的肾移植患者中获取生物标本提供了独特的机会 接受者在基线和拟议随访的4.5至9年期间每年接受治疗。适当同意 已经获得了用于辅助研究的标本，其中许多标本已经 已经被转移到NIDDK标本库。用于辅助研究，如下所示 正在收集标本类型：EDTA血浆，棕黄色涂层，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，没有任何个人识别符。不管怎样 Favorit中降低tHcy的干预是否显著降低了心血管事件发生率， 监测4000名慢性稳定肾移植受者的试验队列，范围从最低随访- 最长4.5年，最长9年，将提供关于动脉硬化性心血管疾病预后的独特数据，以及 (潜在)先天心血管疾病危险因素，在该患者群体中。补充性辅助研究 综述将进一步探讨初始肾功能和蛋白尿程度之间的相互关系。 和/或这些参数的连续变化，Favorit队列中肾脏和心血管疾病的结果。一个 正在进行的NIH资助的Favorit辅助研究(RO1 DK65114-03“Favorit辅助认知试验 [事实]“已经为慢性肾脏疾病的认知功能和影响提供了前所未有的数据 移植。

The FAVORIT trial has several design features that enhance its ability to address the question of whether lowering total homocysteine (they) concentartions 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 FAVORIT 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 (RO1 DK65114-03 "FAVORIT Ancillary Cognitive Trial [FACT]" is already providing unprecedented data on cognitive function and affect in chronic renal transplantation.