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SDCC - Prospective Cohort Study of Chronic Renal Insufficiency (CRIC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by University of Pennsylvania
Sponsor:
Collaborators:
Johns Hopkins University
Case Western Reserve University
University of Michigan
University of Illinois at Chicago
Tulane University
Kaiser Permanente
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00304148
First received: March 14, 2006
Last updated: February 20, 2014
Last verified: July 2013

March 14, 2006
February 20, 2014
July 2003
December 2017   (final data collection date for primary outcome measure)
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 ]
Not Provided
Complete list of historical versions of study NCT00304148 on ClinicalTrials.gov Archive Site
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 ]
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SDCC - Prospective Cohort Study of Chronic Renal Insufficiency
Prospective Cohort Study of Chronic Renal Insufficiency

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 to date, 3612 participants have been enrolled in the CRIC cohort. The goal for Phase III is to enroll 1500 new participants across all seven Clinical centers (214 new participants per center). Participants previously enrolled will be followed for an additional 5 years and newly recruited participants will be followed for up to an additional 5 years. Principles underlying the targeted composition of the cohort of new recruits are very similar as the Phase I recruits, however with some modifications as listed below in the eligibility summary.

No study treatments or interventions will be given to participants in CRIC. Subjects will include a racially and ethnically diverse group of adults aged 45 to 79 years old with a broad spectrum of renal disease severity and proteinuria levels. Participants who are 65 years or older will undergo additional testing to assess physical and cognitive function, social support, and quality of life.

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 3 to 4 hours. 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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

DNA, urine, serum, blood

Probability Sample

The CRIC Study population will include a racially and ethnically diverse group of adult patients with mild-to-moderate CRI. The 1,500 new cohort members will be recruited into the study, compared with participants recruited in Phase I, these individuals will have higher ranges of age and more preserved kidney function, and most will have proteinuria. The population of 1500 new recruits will have similar characteristics as the current CRIC cohort: ~50% with Diabetes, ~50% female, ~45% white and ~45% African-American.

Renal Insufficiency, Chronic
Not Provided
  • CRIC Cohort
  • CRIC Subcohort

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
5112
June 2018
December 2017   (final data collection date for primary outcome measure)

Inclusion Criteria:

During the screening visit a blood sample will be tested to indirectly check kidney function based on the serum creatinine level:

  • Age Range: 45 - 79 years
  • Estimated Glomerular Filtration Rate (GFR): 45 - 70 mL/min/1.73m²
  • Proteinuria: varies dependent on eGRF

Exclusion Criteria:

  • Unable or unwilling to provide informed consent
  • Previously received dialysis (peritoneal and/or hemodialysis) lasting more than one month
  • Prior organ or bone marrow transplant
  • Prior renal transplant
  • Received immunosuppressive or other immunotherapy for primary renal disease or systemic vasculitis that affects the kidneys (i.e., anti-GCM, ANCA, SLE, IgA nephropathy, cryoglobulin, etc.) within the past six months before enrollment
  • Received chemotherapy or alkylating agents for systemic cancer
  • Known cirrhosis
  • NYHA Class III or IV heart failure at baseline
  • Previous diagnosis of multiple myeloma or renal carcinoma
  • Previously diagnosed polycystic kidney disease
  • Known HIV infection and/or AIDS
  • Pregnant or breast-feeding women
  • Currently participating in an interventional clinical trial (i.e., primarily trials of therapeutic agents that may have an effect on renal or cardiovascular outcomes).
  • Institutionalized (e.g., prisoner, nursing home resident, skilled nursing facility resident)
  • Appears unlikely or unable to participate in the required study procedures as assessed by the investigator, study coordinator or designee.
Both
45 Years to 79 Years
No
Contact: Sally Thompson, BA 215-573-8926 SallyJ@upenn.edu
Contact: Nancy Robinson-Garvin, PhD 215-573-4421 narobins@upenn.edu
United States
 
NCT00304148
DK60990, U01DK060990
Yes
University of Pennsylvania
University of Pennsylvania
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • Johns Hopkins University
  • Case Western Reserve University
  • University of Michigan
  • University of Illinois at Chicago
  • Tulane University
  • Kaiser Permanente
Study Director: Harold I. Feldman, M.D., MSCE University of Pennsylvania
University of Pennsylvania
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP