SDCC - Prospective Cohort Study of Chronic Renal Insufficiency (CRIC)
Recruitment status was Active, not recruiting
Insights into the cause of kidney failure have emerged from research, but less is known about the epidemiology of less severe forms of kidney disease known both as chronic kidney disease (CKD) or chronic renal insufficiency (CRI).
The Chronic Renal Insufficiency Cohort (CRIC) Study was established to study the consequences of CKD with a particular focus on cardiovascular illness like myocardial infarction (heart attack) and stroke. The CRIC Study will identify high-risk subgroups of individuals with CRI, informing future treatment trials, and development of preventive therapies.
CRIC is an observational study that will enroll approximately 3000 individuals at thirteen sites across the U.S. and follow participants for up to 5 years. No study treatments or interventions will be given to participants in CRIC. Subjects will include a racially and ethnically diverse group of adults aged 21 to 74 yr with a broad spectrum of renal disease severity, half of whom have diagnosed diabetes mellitus.
Approximately one-third of the study participants will be randomly selected to participate in a substudy to obtains additional information about cardiac and kidney function. If selected, participants will have Iothalamate-GFR (Glomerular Filtration Rate) and/or cardiac CT (Computerized Tomography or CAT Scan)/EBT (Electron Beam Tomography) testing performed. Participants will be evaluated independently for these tests which will be conducted at two time points over the course of study participation.
Renal Insufficiency, Chronic
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Prospective Cohort Study of Chronic Renal Insufficiency|
- The slope of GFR is the primary outcome;Primary outcomes regarding CVD will focus on clinical events indicative of ischemic heart disease, CHF, stroke, and peripheral vascular disease supplemented by radiographic evidence of progressive CVD [ Time Frame: 5 yrs ] [ Designated as safety issue: No ]
- 1.Onset of ESRD; 2.Significant loss of renal function; 3.Composite clinical outcome defined by the occurrence of either 50% decline, or 25 l/min/1.73 m2 decline in GFR from baseline, or onset of ESRD; 4. Slope of change in proteinuria over time. [ Time Frame: 5 yrs ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
DNA, Urine, Nails, serum, blood
|Study Start Date:||July 2003|
|Estimated Study Completion Date:||June 2008|
Eligible men and women who consent will be enrolled in this observational study. Participants will remain under the care of their usual physicians. Questionnaires will be completed and tests will be conducted that will provide information about aspects of kidney and heart health status.
Participants are screened over the course of a brief visit during which informed consent is obtained, height and weight measured, blood drawn and a few forms are completed.
If eligible, a participant will return to the center for a more extensive visit. At the Baseline Visit the following will occur:
- eligibility is confirmed
- weight, height, waist and body water and fat content are measured by Bioelectrical Impedance Analysis (BIA)
- blood pressure and heart rate are recorded
- information about medical history and medication used recently
- blood draw (about ½ cup) for the following tests: CBC (Complete Blood Count), tests of metabolism, and several other heart and kidney tests
- blood pressure in the leg and arm calculated as the Ankle Brachial Index (ABI)
- Electrocardiogram (ECG)
- urine sample and collection of 24-hour urine sample for kidney function testing
- complete questionnaires about quality of life, diet, mood, thought processes and physical activity
- nail clipping
This visit takes about 4 hours. If selected, the Iothalamate GFR test will also be conducted during or shortly after this visit. This test is repeated at the second and fourth annual visits.
Participants will be contacted by telephone six months after the Baseline Visit to ask about recent medical events and medications.
Participants will be asked to return to the center for annual visits during which many but not all of the procedures described above will be conducted. In addition, an echocardiogram will be conducted during the first and fourth annual follow up visits.
Subcohort participants will have a cardiac CT/EBT test conducted during the first and fourth annual follow up visits.
|United States, California|
|Kaiser Permanente of Northern California|
|Oakland, California, United States, 94612|
|University of California at San Francisco|
|San Francisco, California, United States, 94118|
|United States, Illinois|
|University of Illinois at Chicago|
|Chicago, Illinois, United States, 60612|
|United States, Louisiana|
|Tulane University Health Sciences Center|
|New Orleans, Louisiana, United States, 70112|
|United States, Maryland|
|Johns Hopkins Medical Institutions|
|Baltimore, Maryland, United States, 21205|
|University of Maryland Medical System|
|Baltimore, Maryland, United States, 21201|
|United States, Michigan|
|University of Michigan Hospitals|
|Ann Arbor, Michigan, United States, 48106|
|St. John's Hospital and Medical Center|
|Detroit, Michigan, United States, 48236|
|Wayne State - Harper University Hospital|
|Detroit, Michigan, United States, 48201|
|United States, Ohio|
|University Hospitals of Cleveland|
|Cleveland, Ohio, United States, 44106|
|Metrohealth Medical Center|
|Cleveland, Ohio, United States, 44109|
|Cleveland Clinic Foundation|
|Cleveland, Ohio, United States, 44195|
|United States, Pennsylvania|
|University of Pennsylvania Medical Center|
|Philadelphia, Pennsylvania, United States, 19104|
|Study Director:||Harold I. Feldman, M.D., MSCE||University of Pennsylvania|