A Randomized, Controlled Trial for Homocysteine

FAVORIT试验有几个设计特征，可增强其解决以下问题的能力： 降低总同型半胱氨酸浓度可以降低慢性心血管疾病患者的心血管疾病风险。 肾病（CKD）。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。样本量（n=4000; n=3621 招募截至2006年7月5日）是迄今为止最大的一项试验，我们的目标是，计划的随访时间 到2011年6月，是最长的，初步筛选数据表明，基线tHcy水平较高， 比在非肾脏疾病人群中进行的试验更有利。假设预测的FAVORIT 对照组中CVD的事件发生率，试验将保持良好的效力（即，0.87）辨别A 积极降低tHcy治疗可使事件中度减少20%（如果实现）。 提供了一个独特的机会，以获得生物标本的一个大的队列稳定的肾移植 接受者在基线和每年在整个4.5至9年的拟议随访。适当同意 已经获得了使标本可用于辅助研究，许多标本 已经转移到NIDDK标本库。为了在辅助研究中使用， 采集标本类型：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具有条形码ID标签，不含任何个人标识符。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名慢性稳定肾移植受者的试验队列，范围从最低随访- 长达4.5年，最长9年，将提供关于动脉粥样硬化CVD结局的独特数据， （潜在）既往CVD风险因素。补充性辅助研究， 综述将进一步阐述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，以及FAVORIT队列中的肾脏和CVD结局。一个 正在进行的NIH资助的FAVORIT辅助研究（RO 1 DK 65114 -03“FAVORIT辅助认知试验 [事实]”已经提供了前所未有的关于认知功能和慢性肾脏病患者影响的数据。 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.