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SDCC - Prospective Cohort Study of Chronic Renal Insufficiency (CRIC)
This study is ongoing, but not recruiting participants.
First Received: March 14, 2006   Last Updated: October 2, 2008   History of Changes
Sponsors and Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Pennsylvania
Johns Hopkins University
Case Western Reserve University
University of Michigan
University of Illinois
Tulane University School of Medicine
Kaiser Permanente
Information provided by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00304148
  Purpose

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.


Condition
Renal Insufficiency, Chronic

Study Type: Observational
Study Design: Cohort, Prospective
Official Title: Prospective Cohort Study of Chronic Renal Insufficiency

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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

Biospecimen Description:

DNA, Urine, Nails, serum, blood


Enrollment: 3834
Study Start Date: July 2003
Estimated Study Completion Date: June 2008
Groups/Cohorts
CRIC Cohort
CRIC Subcohort

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   21 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

The CRIC Study population will include a racially and ethnically diverse group of adult patients with mild-to-moderate CRI, approximately half of whom will have diagnosed diabetes mellitus (DM). Principles underlying the targeted composition of the cohort are:

  1. adequate representation of target subgroups (e.g. DM, women)
  2. subgroup analysis
  3. sufficient representation of subgroup to enable selection of a subcohort capable of addressing needs for developing CRIC GFR estimating equation
Criteria

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: 21 - 74 years
  • Estimated Glomerular Filtration Rate (GFR): 20 - 70

Exclusion Criteria:

  • Unable or unwilling to provide informed consent
  • Previously received dialysis
  • Prior organ or bone marrow transplant
  • Prior renal transplant
  • Received immunosuppressive or other immunotherapy for primary renal disease
  • Received chemotherapy or alkylating agents for systemic cancer
  • Known cirrhosis
  • Heart failure
  • Previous diagnosis of multiple myeloma or renal carcinoma
  • Known HIV infection and/or AIDS
  • Pregnant women
  • Currently participating in an interventional clinical trial or in a research study that adds significantly to the participant's burden
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00304148

Locations
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
Sponsors and Collaborators
University of Pennsylvania
Johns Hopkins University
Case Western Reserve University
University of Michigan
University of Illinois
Tulane University School of Medicine
Kaiser Permanente
Investigators
Study Director: Harold I. Feldman, M.D., MSCE University of Pennsylvania
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):
Responsible Party: University of Pennsylvania ( Harold I Feldman, M.D., M.S.C.E. )
Study ID Numbers: DK60990, U01-DK060990
Study First Received: March 14, 2006
Last Updated: October 2, 2008
ClinicalTrials.gov Identifier: NCT00304148     History of Changes
Health Authority: United States: Institutional Review Board;   United States: Federal Government

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
Renal Insufficiency Chronic

Study placed in the following topic categories:
Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Chronic
Kidney Diseases

Additional relevant MeSH terms:
Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Chronic
Kidney Diseases

ClinicalTrials.gov processed this record on August 24, 2009