Throughout the world, kidney disease is far more common than most people realize. It’s not a stretch to call it a “hidden epidemic,” as肾脏疾病（8.5亿）的人数大致两倍于糖尿病的人。（1）
慢性肾病（CKD）提出的健康问题是通过这些患者中相关心血管（CV）病的高患病率放大。CKD患者最常见于CV事件。（2）也是CV病患者，30％至60％的肾病。（3）
尽管这个肾脏和之间的紧密关系CV disease, patients with CKD are frequently excluded from cardiovascular (CV) clinical trials. The latest systemic review of CV trials published between 2006 and 2013 found that more than half (57 percent) excluded patients with kidney disease.(4) Failure to include CKD patients in CV trials leads to gaps in the data we have about the efficacy and safety of common drugs in our CKD patients and the value of new breakthrough therapies in treating their CV disease.
缺乏CKD患者中CV干预的安全性和疗效证据，使CKD患者的CV病挑战。我们还没有根据我们应该频繁地调查CKD患者，因此相关数据并不像他们直接在试验中都学习的那样强大。
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关于ckd的鲜为人知的事实
慢性肾脏疾病（CKD）定义为肾脏结构或功能的任何异常，持续三个月以上。你知道吗：
- CKD的患病率大致增加了患有糖尿病（6）的人数（6）和比癌症的患病率超过20倍（4200万）（7）
- 美国血液透析每年的年费是88,195美元（8）
- 每年，Medicare花费99美元billion(6% of its budget!) on CKD patients
- Declining kidney function is associated with worse outcomes (9):
- 分别增加22和36（每100人）的CV事件率分别用于4阶段的4 CKD（EGFR为15-29ml / mim / m 2）和第5阶段（EGFR <15ml / mim / m2）
- 阶段4和5 CKD分别为11和14（每100人）的显着高死亡率
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评估肾脏药物和设备开发中这种差距的一组群体是肾脏健康倡议（khi），这是美国肾脏学会（ASN）和美国食品和药物管理局（FDA）之间的新型公私伙伴关系。我担任董事会，我们的90多个利益攸关方会员，我们希望看到更多批准用于肾病患者的药物和医疗器械。由心脏病学家Charles Herzog和肾病学家们担任一名特定的工作组朱莉·伊希达博士，旨在识别包括阶段4 CKD阶段（EGFR（5）的CKD患者的障碍和解决方案（EGFR（5））和与阶段5和透析，在更多CV临床试验中。
取得进展：最近的khi研讨会
In the2017年12月Cardiovascular Clinical Trialists Forum（CVCT），我们的KHI工作组参加了致力于CKD的小组，并为患者和行业利益相关者（包括赞助商公司）推出了调查，以探讨CKD患者经常被排除在临床试验中的原因。调查结果载于2018年9月初举行的研讨会，并由美国FDA，加拿大卫生，肾病学家，心脏病学家，患者和药物和设备赞助商的参与者参加。我与四个突出会议之一进行了共同调节，我的鸽友心脏病学同事，乔纳森·普莱恩博士，也代表了一个专注于试验设计的小组的景点。他指出，“Going into this meeting I was unaware of the degree to which CKD patients have been excluded from our CV trials. The reasons for this are often not well considered. Thus, the KHI meeting was a unique opportunity to directly exchange insights between the two specialties and with regulators and patients…a great collaborative meeting.”
The discussion groups were tasked with identifying the challenges of, and solutions to, four aspects of the issue：研究设计，可行性/财务和患者参与。On the basis of the stakeholder perceptions gathered in the survey, each group offered practical recommendations. The outcome of the meeting will be shared in a paper that I am co-authoring for submission to a peer-reviewed journal…Watch for more details.
如果您想在肾脏和简历研究中讨论您的需求，请在Covance与我们联系。
Dr. Gillespie, a board certified nephrologist, is vice president and therapeutic head of Nephrology at Covance. Additionally, she cares for CKD patients as an adjunct professor at the University of North Carolina, Division of Nephrology。Plehn博士is vice president of Cardiovascular Medicine at Covance and a clinical professor of Medicine at Drexel University School of Medicine.
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1http://www.who.int/news-room/fact-sheets/detail/diabetes.
2 Go, A.S., et al., Chronic kidney disease and the risk of death, cardiovascular events, and hospitalization. New England Journal of Medicine, 2004;35(13):1296-1305.
3 Kidney Health Initiative, “Kidney Health Initiative Workshop on Understanding and Overcoming the Challenges to Involving Patients with Kidney Disease in Cardiovascular Trials”
4 Konstantinidis，Jama Im 2016
5 eGFR is the estimated glomerular filtration rate
6.http://www.who.int/news-room/fact-sheets/detail/diabetes.
7.https://ourworldindata.org/cancer
8 United States Renal Data System. 2017 USRDS annual data report: Epidemiology of kidney disease in the United States. National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, 2017
9，A.S.等，慢性肾病和死亡，心血管事件和住院风险。新英格兰医学杂志2004; 35（13）：1296-1305
