CRIC 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. Over the past several decades, the incidence and prevalence of end-stage renal disease (ESRD) has increased steadily in the United States and other countries. Relatively little is known about the epidemiology of chronic renal insufficiency (CRI), the stage of reduced kidney function prior to ESRD. CRI affects more than 10 million Americans. The burden of morbidity and mortality from CRI derives from the frequent but variable progression of CRI toward ESRD and the disproportionate risk of cardiovascular disease (CVD) in the setting of CRI. In 2001, the National Institute of Diabetes, Digestive, and Kidney Diseases (NIDDK) established the Chronic Renal Insufficiency Cohort (CRIC) Study. The main goals of CRIC are to determine risk factors for CRI progression and risk factors for CVD in the setting of CRI. It is anticipated that results from CRIC will provide the scientific foundation for future treatments, will facilitate the design of subsequent clinical trials, and will ulitmately lead to the prevention of ESRD and its complications. Hopkins (with a subcontract to U.Maryland) is one of seven clinical centers that will enroll approximately 430-500 individuals with CRI to establish a cohort of 3,000 subjects (~50% diabetic). The study anticipates that ~6,000 individuals studywide (~1,000/center) will be screened in-person to achieve the cohort sample size. Participants are followed until death or dropout from the study. The duration of follow-up will be 3 to 6 years, depending on the date of enrollment. Each year during follow-up, annual in-person visits will occur as well as 1-2 telephone contacts. At the annual visits, the following data will be collected: fasting blood specimen, 24 hour urine collection, questionnaires (demographics, diet, co-morbid medical conditions, quality of life, health care utlilization, intercurrent medical events), EKG, bioelectrical impedance, and ankle-brachial index. Every other year, an echocardiogram will be performed. One third of CRIC participants (1,000 studywide, ~150 per center) will be part of the 'subcohort' or 'substudy' that receives additional study procedures (GFR and EBT).