- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02405650
CRIC-Visceral Adiposity and Physical Fitness in Chronic Kidney Disease (CRIC-VAP)
Visceral Adiposity and Physical Fitness in CKD
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Illinois
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Chicago, Illinois, United States, 60612
- University of Illinois at Chicago
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-
Maryland
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Baltimore, Maryland, United States, 21201
- University of Maryland Medical System
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Baltimore, Maryland, United States, 21207
- Johns Hopkins University - ProHealth
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-
Michigan
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Ann Arbor, Michigan, United States, 48109
- University of Michigan
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Ohio
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Cleveland, Ohio, United States, 44195
- Cleveland Clinic
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Cleveland, Ohio, United States, 44106
- Case Western Reserve University
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Cleveland, Ohio, United States, 44109
- Metro Health Medical Center
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania Scientific & Data Coordinating Center
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Texas
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Houston, Texas, United States, 77030
- Baylor College of Medicine
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age 21-79
- Estimated Glomerular Filtration Rate 20-74 ml/min/1.73m^2
Exclusion Criteria:
- Pacemaker
Metallic prosthesis or foreign body (joints, heart valves, clips)
*Sites may include patients with cardiac stents and/or dental implants based on the local Radiology department criteria i.e. if there are no restrictions, they can include patients with stents and/or dental implants. If the Radiology department mandates the type of stent details and/or dental implants, site coordinator should provide this to the local Radiology department and obtain permission before enrolling the subject.
- Severe claustrophobia
Severe osteoarthritis (use of walker or other assisted devices)
*Sites may include patients with cane (single or quad).
- Recent cardiovascular or cerebrovascular events (within 6 months prior to enrollment)
- Kidney transplant
- Currently on dialysis
- Peripheral vascular disease limiting long distance walking
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
CRIC VAP cohort
If eligible, the participant will have additional testing at regular annual CRIC Visit. The following will occur:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Composite of mortality, cardiovascular events, End Stage Renal Disease (ESRD) and 50% decline in estimated glomerular filtration rate (eGFR)
Time Frame: 5 years
|
Since visceral adiposity is related to both cardiovascular disease and kidney function and to adequately power the study, we chose the composite end-point.
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
All-cause death
Time Frame: 5 years
|
Death details are obtained from linkage of the CRIC study with the National Death Index.
|
5 years
|
Cardiovascular events (acute myocardial infarction, congestive heart failure, cardiac arrhythmias, peripheral vascular disease and cerebrovascular events)
Time Frame: end of the study
|
Once a patient reports a clinical event or hospitalization during the study visit, de-identified charts are adjudicated by review of hospital records by two physician reviewers and linkage with other national database
|
end of the study
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Renal events - End Stage Renal Disease plus 50% decline in Glomerular filtration rate (GFR)
Time Frame: 5 years
|
Incident End Stage Renal Disease is being defined as initiation of chronic dialysis or kidney transplantation
|
5 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Sankar Navaneethan, M.D., Baylor College of Medicine
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 37396 CRIC VAP
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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