CHRONIC RENAL INSUFFICIENCY IN N AMER PEDIATRIC RENAL TRANSPLANT COOP STUDY

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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