CKiD Study Information
The design of the CKiD study is a prospective, observational cohort of children with chronic kidney disease. Exposures will be measured at baseline and scheduled annual follow-up visits will permit the subsequent updating of the exposures in cohort participants. Outcomes will also be assessed at the annual visits and they include: measures of kidney function; 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 ESRD and death. Such events will provide time-to-event data to determine heterogeneity of times to ESRD in children with mild to moderate chronic kidney disease.
- Age between 1 and 16 years (before 17th birthday)
- Estimated (based on SCr) GFR between 30 and 90 ml/min/1.73m2
- Willingness and ability to provide informed consent and assent
- Renal, other solid organ, bone marrow or stem cell transplantation
- Dialysis treatment within the past three months
- Cancer diagnosis or HIV diagnosis/treatment within last twelve months
- Current pregnancy or pregnancy within past twelve months
- Inability to complete major data collection procedures (e.g., allergic reaction to iodine or iohexol)
- Current enrollment in a randomized clinical trial in which the specific treatment is unknown
- Not fluent in English or Spanish
- Move out of area of any participating CKiD site (Families can be transferred to another CKiD site if they move)
- History of structural heart disease
- Genetic syndromes involving the central nervous system (e.g., Downs syndrome)
- History of severe to profound mental retardation (i.e., IQ <40, significant impairment in adaptive function and/or inability to independently execute self-care skills)
Description of Study Population
The CKiD study population will include two cohorts. Cohort 1 586 racially and ethnically diverse children, age 1-16 years old with mildly to moderately impaired kidney function, defined by an estimated GFR between 30 and 90 ml/min|1.73m2 by the Schwartz formula (sGFR). Cohort 2 will include approximately 280 children with mildly impaired kidney function, defined as an estimated GFR between 45 and 90 by the updated Schwartz formula (eGFR).
Study Visit Schedule
The table below outlines the tests and measurements taken at each CKiD Study visit. Once a participant undergoes renal replacement therapy (dialysis or transplantation), a brief interview and chart review are performed annually.
The CKiD Study collects serum, plasma, urine, hair, nails and DNA samples during study visits.