CHRONIC RENAL INSUFFICIENCY IN N AMER PEDIATRIC RENAL TRANSPLANT COOP STUDY

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。这是一项针对儿童慢性肾脏疾病的前瞻性、观察性、流行病学多中心研究。本研究的主要目的是：1)确定肾功能下降的危险因素；2)确定肾功能的进行性下降如何影响神经认知功能和行为、心血管疾病的危险因素、生长衰竭及其相关发病率。该协议列出了13个具体的假设。将在基线和年度随访时测量暴露量。结果将在年度访问时进行评估，包括：肾功能测量（gfr -肾小球滤过率）；神经认知功能;心血管疾病危险因素标志物；生长和其他合并症。该研究将使用队列设计的力量，定期访问，在标准化程序下测量疾病进展的标志物。标志物的水平和纵向变化将构成主要结果。该研究将收集主要关注终末期肾病（ESRD）和死亡的临床事件数据。这些事件将提供时间到事件的数据，以确定轻度至中度慢性肾病儿童发生ESRD时间的异质性。该研究将招募540名1-16岁轻度至中度肾功能受损的儿童。目标入组按年龄组和GFR水平分层。该研究包括4年5次访问。在研究的第二年入组的受试者将在3年内只参加4次访问。中西部临床协调中心位于密苏里州堪萨斯城的儿童慈善医院，东海岸临床协调中心位于马里兰州巴尔的摩的约翰霍普金斯医疗机构。该地点预计有25名受试者。GCRC将在基线、第2年和第6年的3次门诊研究访问中使用

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This is a prospective, observational, epidemiological multicenter study of children with chronic kidney disease. The primary goals of this study are: 1) to determine the risk factors for decline in kidney function; and 2) to define how a progressive decline in kidney function impacts neurocognitive function and behavior, the risk factors for cardiovascular disease, and growth failure and its associated morbidity. The protocol lists 13 specific hypotheses. Exposures will be measured at baseline and at annual follow-up visits. Outcomes will be assessed at the annual visits and they include: measures of kidney function (GFR-Glomerular Filtration Rate); neurocognitive function; markers of risk factors for cardiovascular disease; growth and other co-morbid conditions. The study will use the power of the cohort design with regularly scheduled visits at which markers of disease progression will be measured under standardized procedures. Levels and longitudinal changes in markers will constitute the primary outcomes. The study will collect data on clinical events with primary interest in end stage renal disease (ESRD) and death. Such events will provide time-to-event data to determine heterogeneity of time to ESRD in children with mild to moderate chronic kidney disease. The study will enroll 540 children age 1-16 years old with mildly to moderately impaired kidney function. Target enrollment is stratified by age group and level of GFR. The study includes 5 visits over 4 years. Subjects enrolled during the second year of the study will only participate in 4 visits over 3 years. The mid-west clinical coordinating center is at the Children's Mercy Hospital in Kansas City, MO, and the east-coast clinical coordinating center is Johns Hopkins Medical Institutions in Baltimore, MD. 25 subjects are expected at this site. The GCRC will be utilized for 3 of the outpatient study visits at baseline, Year 2 and Ye