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Trial record 1 of 1 for:    NCT00304148
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SDCC - Prospective Cohort Study of Chronic Renal Insufficiency (CRIC)

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ClinicalTrials.gov Identifier: NCT00304148
Recruitment Status : Active, not recruiting
First Posted : March 17, 2006
Last Update Posted : August 5, 2019
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
University of Pennsylvania

Brief Summary:

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, over 5000 participants have been enrolled in the CRIC cohort. The goal for CRIC 2018 which began in July 2018 is to follow participants for an additional 5 years. To maximize the opportunities inherent in this unique scientific resource, the CRIC Study will, in its next phase, pursue a multifaceted strategy involving: (a) continued follow-up of the cohort and investigation of a broad array of factors associated with the progression and consequences of CKD utilizing state-of-the-art methods in biostatistics and bioinformatics; and (b) the use of novel remote data collection techniques to identify trajectories of kidney function and cardiovascular risk sub-phenotypes.


Condition or disease
Renal Insufficiency, Chronic

Detailed Description:

Previously enrolled participants who reconsent to the next phase. CRIC 2018, 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 who reconsent to this phase will return to the center for a more extensive visit. At the Clinic Visit the following will occur:

  • weight is measured
  • 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)
  • urine sample collection for kidney function testing
  • complete questionnaires about quality of life, diet, mood, thought processes and physical activity

This visit takes about 1 to 2 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.

Additionally, up to 1500 CRIC participants will be asked to participate in one of two substudies using remote data collection techniques to identify trajectories of kidney function and cardiovascular risk sub-phenotypes.


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Study Type : Observational
Estimated Enrollment : 5112 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Cohort Study of Chronic Renal Insufficiency
Study Start Date : July 2003
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine


Group/Cohort
CRIC Cohort
CRIC Subcohort



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Biospecimen Retention:   Samples With DNA
DNA, urine, serum, blood


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   45 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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. 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.
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: 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00304148


Locations
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United States, California
Kaiser Permanente of Northern California
Oakland, California, United States, 94612
University of California
San Francisco, California, United States, 94143-0532
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
University of Maryland Medical System
Baltimore, Maryland, United States, 21201
Johns Hopkins Medical Institutions
Baltimore, Maryland, United States, 21205
United States, Michigan
University of Michigan Hospitals
Ann Arbor, Michigan, United States, 48106
Wayne State - Harper University Hospital
Detroit, Michigan, United States, 48201
St. John Hospital and Medical Center/RRRI
Detroit, Michigan, United States, 48236
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
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
Investigators
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Study Director: Harold I. Feldman, M.D., MSCE University of Pennsylvania

Additional Information:
Publications of Results:

Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00304148     History of Changes
Other Study ID Numbers: DK60990
U01DK060990 ( U.S. NIH Grant/Contract )
First Posted: March 17, 2006    Key Record Dates
Last Update Posted: August 5, 2019
Last Verified: August 2019
Keywords provided by University of Pennsylvania:
Renal Insufficiency Chronic
Additional relevant MeSH terms:
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Renal Insufficiency
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases