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

描述(由申请人提供)： Favorit试验有几个设计特点，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疾病(CKD)患者心血管疾病风险的问题。在目前每月152次随机试验的三个月速度下，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；截至2006年7月5日招募的n=3621)是迄今为止我们目标试验的最大规模，计划的跟踪时间到2011年6月是最长的，初步筛查数据表明，FAVIORIT的基线tHcy水平高于在非肾脏疾病人群中进行的试验。假设控制组中心血管疾病的预计Favorit事件发生率发生，试验将保持强大的动力(即0.87)，以识别积极的tHcy降低治疗使事件适度减少20%(如果实现)。Favorit试验提供了一个独特的机会，可以从一大批稳定的肾移植受者身上获得生物标本，在基线和拟议的4.5至9年的随访期间每年进行。已经获得适当的同意，以便提供标本进行辅助研究，许多标本已经转移到NIDDK标本储存库。为了用于辅助研究，收集了以下类型的标本：EDTA血浆、黄褐色涂层、红细胞、血清、柠檬酸钠血浆和尿液。这些标本有条形码的身份标签，没有任何个人识别符。无论Favorit中降低tHcy的干预措施是否显著降低心血管事件发生率，监测4000名长期稳定的肾移植受者的试验队列，从最短的4.5年到最长的9年，都将提供关于动脉硬化性心血管结局的独特数据，以及(潜在的)先前心血管疾病危险因素。正在审查中的补充辅助研究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，以及Favorit队列中肾脏和心血管疾病的结果。美国国立卫生研究院资助的一项正在进行的Favorit辅助研究(R01 DK65114-03“Favorit辅助认知试验[FACT]”)已经提供了有关慢性肾移植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.