Frequent Hemodialysis Network - West Coast Consortium

描述(由申请人提供)： 频繁血液透析网络(FHN)研究是一项随机临床试验，旨在测试与频繁(每周6次)与常规(每周3次)血液透析的可行性、安全性和有效性相关的假设。最近完成的由NIDDK资助的Memo研究表明，当每周进行三次血液透析时，平衡Kt/Vurea的显著增加对存活率和许多其他结果没有明显影响。临床经验和已发表的轶事报道表明，更频繁的透析可能会减少住院次数和住院时间，改善对容量超负荷、高血压和贫血的控制，纠正矿物质代谢障碍，并提高生活质量。鉴于与终末期肾病相关的高死亡率和显著的发病率，有必要对替代透析策略进行严格的评估。研究人员在整个加利福尼亚州建立了一个由大学和社区的肾病学家和透析单位组成的联盟-加州协调临床中心(CCC)。我们为城市和郊区社区提供广泛的种族、民族和社会经济多样性服务。我们打算按照RFA的要求招收125名科目(成人和儿童)。受试者的招募、保留和遵守情况一直很好；已经制定了计划，通过接近更多的当地透析设施来扩大现有地点的招募，并扩大到参与大学附属的退伍军人医疗中心的招募。样本量将不足以证明不同群体之间存活率的差异。将继续仔细跟踪安全性和临床事件(例如住院)。随着继续的登记和随机化，这项研究应该有足够的能力来检测共同初级结果(死亡率和左心室质量变化的组合；以及SF-36的死亡率和身体健康综合变化的组合)中在临床上有意义的差异。这项研究也应该有足够的能力来检测其他次要结果中有临床意义的差异。切尔托博士和他的同事们已经组建了一支才华横溢的研究人员和协调人团队。该财团与多个行业合作伙伴进行了有效的合作。我们共同致力于与其他CCC和DCC进行合作和建设性的合作，以实现所有FHN研究目标。

DESCRIPTION (provided by applicant): The Frequent Hemodialysis Network (FHN) Study is a randomized clinical trial designed to test hypotheses related to the feasibility, safety, and efficacy of frequent (6x per week) vs. conventional (3x per week) hemodialysis. The recently completed NIDDK-funded MEMO Study demonstrated that survival and many other outcomes were not appreciably influenced by significant increases in equilibrated Kt/Vurea, a parameter of dialysis dose, when hemodialysis was given thrice weekly. Clinical experience and published anecdotal reports suggest that more frequent dialysis may result in reduced frequency and duration of hospitalization, improved control of volume overload, hypertension and anemia, correction of disorders of mineral metabolism, and enhanced quality of life. Given the high mortality rates and significant morbidity associated with end-stage renal disease, a rigorous evaluation of alternative dialysis strategies is warranted. The Investigators have constructed a consortium of University- and community-based nephrologists and dialysis units throughout the state of California - the California Coordinating Clinical Center (CCC). We serve urban and suburban communities with extensive racial, ethnic and socioeconomic diversity. We intend on enrolling 125 subjects (adults and children) as requested by the RFA. Subject recruitment, retention and adherence have been excellent; plans are in place to augment recruitment at existing sites by approaching additional local dialysis facilities and to expand recruitment to VA medical centers affiliated with participating universities. The sample size will not be sufficient to demonstrate a difference in survival among groups. Safety and clinical events (e.g., hospitalization) will continue to be carefully tracked. With continued enrollment and randomization, the study should have sufficient power to detect clinically meaningful differences in the co-primary outcomes (the composite of mortality and change in left ventricular mass; and the composite of mortality and change in the Physical Health Composite of the SF-36). The study should also have sufficient power to detect clinically meaningful differences in other secondary outcomes. Dr. Chertow and his colleages have assembled a talented group of investigators and coordinators. The consortium has worked effectively with multiple industry partners. We are collectively committed to working cooperatively and constructively with the other CCC and DCC to reach all FHN study goals.