Clinical Phenotyping Resource and Biobank Core of the Michigan O'Brien Renal Center

Study acronym: C-PROBE
StatusEnrolling by Invitation
PhaseNot specified
Started

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Trial flagged as At Risk
Primary endpoint added 0 → 1 primary endpoints
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Record History

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  1. Primary endpoint(s) modified Show 5 more changesShow less
    • Trial status changed: Recruiting → Enrolling by Invitation
    • Eligibility criteria expanded, about 9 words
    • Study description expanded, about 81 words
    • Site details revised at 5 of 5 sites
    • Collaborators: 3 to 4
  2. Primary and study completion dates: Jul 2025 to Jul 2030
    • Enrollment target: 1620 to 1800
    • Site details revised at 5 of 5 sites
    v13
  3. Re-verified, no change to tracked fieldsv12
  4. Primary and study completion dates: Jul 2022 to Jul 2025
    • Site contacts updated at 1 of 5 sites
    v11
  5. Collaborators: 6 to 3v10
Show 8 earlier versionsHide 8 earlier versions
  1. Study sites: 6 to 5v9
  2. 2 versions Re-verified since Jul 9, 2019, no change to tracked fieldsv7-v8
  3. Primary and study completion dates: Jul 2018 to Jul 2022v6
  4. Re-verified, no change to tracked fieldsv5
  5. Site contacts updated at 1 of 6 sites
    • Study arms: 2 to 3
    v4
  6. Enrollment target: 1500 to 1620v3 Show 4 more changesShow less
    • Study sites: 4 to 6
    • Primary and study completion dates: Jul 2018
    • Eligibility criteria shortened, about 11 words
    • Collaborators: 3 to 6
  7. Eligibility criteria expanded, about 22 words
    • Collaborators revised (3)
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Chronic kidney disease (CKD) affects approximately 26 million Americans and disproportionately manifests in specific race and ethnic groups. Patients burdened with CKD have significant morbidity and reduced life expectancy. In addition to excessive suffering and lost productivity, the cost of managing this epidemic has reached $40 billion annually. The recognition that CKD is a major public health problem is reflected in the fourteen objectives outlined in Healthy People 2020 to begin to address the disease burden. Advancement in approaches to halt CKD progression has been slow despite growing global awareness of disease burden. This O'Brien Kidney Research Core will create opportunities for novel insights through characterization of tissue profiles that will define new disease markers and molecular pathways and will be available to all kidney investigators on the www. It will thereby fundamentally alter the starting point for research into prevention of progression of these kidney diseases. C-PROBE is an essential element of the center grant and presents a biomedical resource core consisting of: (1) clinical phenotyping (that is, systematic identification of observable physical and biomedical characteristics) of kidney disease patients including the accurate measurement of kidney function; and (2) a specimen BioBank which will store blood, urine and kidney tissue samples. A key component of C-PROBE is therefore that it contains a proven mechanism to collect samples from high risk groups including minorities, at the institutions of University of Michigan Health System, St. John Hospital, Wayne State University in Michigan, John H. Stroger Hospital in Illinois, Temple University Health System in Pennsylvania, and Levine Children's Hospital in North Carolina. This mechanism will feed the other Cores and provide biomedical investigators with approved projects the access to a dynamic pool of well characterized high risk kidney disease patients and their biological specimens to conduct high caliber translational research.
Trial Details
NCT Number NCT01016613
Lead Sponsor University of Michigan
Collaborators: St. John Health System, Michigan, Temple University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Renal Pre-Competitive Consortium (RPC2)
Conditions
(from sponsor)		 Chronic Kidney Disease, Glomerulopathy
Related terms Glomerulonephritis, Kidney Diseases, Nephrotic Syndrome, Proteinuria, Renal Insufficiency, Chronic
Enrollment 1,800 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov