The German Chronic Kidney Disease (GCKD) study: design and methods
The German Chronic Kidney Disease (GCKD) study: design and methods
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DOI：
10.1093/ndt/gfr456
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发表时间：
2012-04-01
影响因子：
6.1
通讯作者：
Titze, Stephanie
中科院分区：
文献类型：
--
作者：
Eckardt, Kai-Uwe;Baerthlein, Barbara;Titze, Stephanie
背景慢性肾脏病（CKD）越来越被认为是一个全球性的健康问题。导致CKD的条件，CKD的健康影响和预后在受影响的个体之间存在显著差异。特别是，肾衰竭和心血管死亡率是CKD患者的竞争风险。有针对性的干预的机会是非常有限的，到目前为止，需要提高对CKD的自然过程，与各种临床终点和合并症的风险因素，以及潜在的致病机制的理解。德国慢性肾病（GCKD）研究是一项前瞻性观察性国家队列研究。其目的是招募总计5000名接受肾脏护理的各种病因的CKD患者，并对其进行长达10年的随访。在入组时，男性和女性患者的估计肾小球滤过率（eGFR）为30-60 mL/min x 3 1.73m（2），或在eGFR >60 mL/min x 3 1.73m（2）的情况下出现明显的蛋白尿。标准化收集生物材料，包括DNA、血清、血浆和尿液，将允许使用假设驱动和无假设方法识别和验证与CKD、CKD进展和相关并发症相关的生物标志物。患者招募和随访是通过与全国执业肾病学家合作的学术肾病中心网络组织的。GCKD研究将建立迄今为止最大的不需要肾脏替代治疗的CKD患者队列之一。其设计与其他观察性CKD研究（包括已在美国和日本建立的队列）相似，将允许进行比较和联合分析，以确定重要的种族和地理差异，并增加识别相关风险因素和标志物的机会。
Background. Chronic kidney disease (CKD) is increasingly recognized as a global health problem. The conditions leading to CKD, the health impact of CKD and the prognosis differ markedly between affected individuals. In particular, renal failure and cardiovascular mortality are competing risks for CKD patients. Opportunities for targeted intervention are very limited so far and require an improved understanding of the natural course of CKD, of the risk factors associated with various clinical end points and co-morbidities as well as of the underlying pathogenic mechanisms.Methods. The German Chronic Kidney Disease (GCKD) study is a prospective observational national cohort study. It aims to enrol a total of 5000 patients with CKD of various aetiologies, who are under nephrological care, and to follow them for up to 10 years. At the time of enrolment, male and female patients have an estimated glomerular filtration rate (eGFR) of 30-60 mL/min x 3 1.73m(2) or overt proteinuria in the presence of an eGFR >60 mL/min x 3 1.73m(2). Standardized collection of biomaterials, including DNA, serum, plasma and urine will allow identification and validation of biomarkers associated with CKD, CKD progression and related complications using hypothesis-driven and hypothesis-free approaches. Patient recruitment and follow-up is organized through a network of academic nephrology centres collaborating with practising nephrologists throughout the country.Conclusions. The GCKD study will establish one of the largest cohorts to date of CKD patients not requiring renal replacement therapy. Similarities in its design with other observational CKD studies, including cohorts that have already been established in the USA and Japan, will allow comparative and joint analyses to identify important ethnic and geographic differences and to enhance opportunities for identification of relevant risk factors and markers.