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）与传统（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 NIDDK 资助的 MEMO 研究表明，当每周进行三次血液透析时，生存和许多其他结果并未受到平衡 Kt/Vurea（透析剂量参数）显着增加的影响。临床经验和已发表的轶事报告表明，更频繁的透析可能会减少住院频率和住院时间，改善对容量超负荷、高血压和贫血的控制，纠正矿物质代谢紊乱，并提高生活质量。鉴于与终末期肾病相关的高死亡率和显着发病率，有必要对替代透析策略进行严格评估。研究人员在整个加利福尼亚州建立了一个由大学和社区肾脏病专家和透析单位组成的联盟——加利福尼亚协调临床中心（CCC）。我们为具有广泛种族、民族和社会经济多样性的城市和郊区社区提供服务。我们打算按照 RFA 的要求招募 125 名受试者（成人和儿童）。受试者招募、保留和依从性都非常出色；我们已制定计划，通过联系更多当地透析设施来增加现有地点的招募，并将招募范围扩大到参与大学附属的退伍军人事务部医疗中心。样本量不足以证明各组间生存率的差异。将继续仔细跟踪安全性和临床事件（例如住院治疗）。随着入组和随机化的持续进行，该研究应该有足够的能力来检测共同主要结果（死亡率和左心室质量变化的综合结果；以及死亡率和 SF-36 身体健康综合变化的综合结果）中具有临床意义的差异。该研究还应该有足够的能力来检测其他次要结果中具有临床意义的差异。切尔托博士和他的同事组建了一支才华横溢的研究人员和协调员团队。该联盟与多个行业合作伙伴进行了有效合作。我们共同致力于与其他 CCC 和 DCC 进行建设性合作，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.