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. Hypothesis:
The aims of this multi-institution study are: 1. to determine the risk factors for progression of pediatric Chronic Kidney Disease (CKD) 2. to examine the impact of CKD on neurocognitive development 3. to examine the impact of CKD on cardiovascular health 4. to examine the impact of CKD on growth The design of the CKD study is a prospective, observational cohort of children with CKD. Outcomes assessed at the annual visits will include: measures of kidney function; neurocognitive function; markers of risk factors for cardiovascular disease; growth and other co-morbid conditions. At each visit, patients will have a targeted physical exam (mid-arm circumference measured and blood pressure taken; heart rate, temperature, height and weight measured; head-circumference measured (ages 1-3); pubertal status assessed by Tanner staging), a general medical history taken and core biochemical measures (sodium, potassium, chloride, bicarbonate, BUN, cystatin C, creatinine, glucose, albumin, calcium, phosphate, and a complete blood count). Additionally, subjects who choose to participate in a biological and genetic specimen repository will have samples taken at each visit. Endpoints: Principal outcomes to measure the progression of kidney disease in children are two-fold. 1. The first principal outcome is the rate of decline of the biomarker Glomerular Filtration Rate (GFR), which is measured repeatedly over time in cohort participants. Combining the measured GFRs with the estimated GFRs based on an internally derived formula will result in a database with yearly GFR measurements. All inferences will incorporate methods of multiple imputations to acknowledge the estimation of GFR in the odd year of follow-up. 2. The second principal outcome is the time-to-end-stage renal disease (ESRD), defined by transplantation, dialysis, or when GFR reaches a pre-specified threshold level [GFR <15 mL/min (1.73m2)].
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