Design of Clinical Trials in Acute Kidney Injury: A Report from an NIDDK Workshop-Prevention Trials
Design of Clinical Trials in Acute Kidney Injury: A Report from an NIDDK Workshop-Prevention Trials
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DOI：
10.2215/cjn.12811211
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发表时间：
2012-05-01
影响因子：
9.8
通讯作者：
Star, Robert A.
中科院分区：
文献类型：
--
作者：
Okusa, Mark D.;Molitoris, Bruce A.;Star, Robert A.
AKI 是一个越来越常见的重要临床问题。尽管支持治疗取得了进展，但与 AKI 相关的死亡率仍然很高。 AKI 幸存患者的长期死亡率增加，并且出现 CKD 和进展为 ESRD 的风险似乎增加。目前尚无经证实有效的药物疗法可用于预防或治疗 AKI。要解决这一未满足的需求，需要在准确理解关键病理生理事件和实施精心设计的临床试验的基础上开发新型治疗药物。为了满足这一需求，美国国家糖尿病、消化和肾脏疾病研究所于 2010 年 12 月主办了“急性肾损伤的临床试验：当前的机会和障碍”研讨会。该活动汇集了来自学术界、工业界、美国国立卫生研究院以及美国食品和药物管理局的代表。我们报告了工作组的讨论，这些工作组制定了预防两个患者群体中 AKI 的临床试验大纲：有发生 AKI 风险或正在发生 AKI 的接受择期手术的患者，以及有对比剂诱发 AKI 风险的患者。在这两个人群中，可以在相对于肾损伤的最佳时间进行一级预防或二级治疗。工作组详细说明了这些组研究的主要和次要终点，并探索了使用适应性临床试验设计来试验新的预防策略，以改善 AKI 患者的预后。临床 J Ant Soc Nephrol 7：851-855，2012。号码：10.2215/CJN.12811211
AKI is an important clinical problem that has become increasingly more common. Mortality rates associated with AKI remain high despite advances in supportive care. Patients surviving AKI have increased long-term mortality and appear to be at increased risk of developing CKD and progressing to ESRD. No proven effective pharmacologic therapies are currently available for the prevention or treatment of AKI. Advances in addressing this unmet need will require the development of novel therapeutic agents based on precise understanding of key pathophysiological events and the implementation of well designed clinical trials. To address this need, the National Institute of Diabetes and Digestive and Kidney Diseases sponsored the "Clinical Trials in Acute Kidney Injury: Current Opportunities and Barriers" workshop in December 2010. The event brought together representatives from academia, industry, the National Institutes of Health, and the US Food and Drug Administration. We report the discussions of workgroups that developed outlines of clinical trials for the prevention of AKI in two patient populations: patients undergoing elective surgery who are at risk for or who develop AKI, and patients who are at risk for contrast-induced AKI. In both of these populations, primary prevention or secondary therapy can be delivered at an optimal time relative to kidney injury. The workgroups detailed primary and secondary endpoints for studies in these groups, and explored the use of adaptive clinical trial designs for trials of novel preventive strategies to improve outcomes of patients with AKI. Clin J Ant Soc Nephrol 7: 851-855,2012. doi: 10.2215/CJN.12811211