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Clinical Phenotyping Resource and Biobank Core of the Michigan O'Brien Renal Center (C-PROBE)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by University of Michigan.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
St. John Health System, Michigan
University of Illinois at Chicago
Wayne State University
Information provided by:
University of Michigan
ClinicalTrials.gov Identifier:
NCT01016613
First received: November 18, 2009
Last updated: April 7, 2011
Last verified: April 2011

November 18, 2009
April 7, 2011
January 2009
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Complete list of historical versions of study NCT01016613 on ClinicalTrials.gov Archive Site
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Clinical Phenotyping Resource and Biobank Core of the Michigan O'Brien Renal Center
Clinical Phenotyping Resource and Biobank Core of the Michigan O'Brien Renal Center

More than 10 million Americans have chronic kidney disease and every year, approximately 100,000 new patients develop end stage renal disease (ESRD) resulting in incalculable human suffering, a high rate of premature mortality, catastrophic physical and emotional disability and prohibitive costs to the U.S. health care system. The current medical therapies for chronic kidney disease, which disproportionately affect African Americans and other minority groups and account for 70% of ESRD, cases are woefully inadequate. 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, that will feed the other Cores and provide biomedical investigators at the institutions of University of Michigan Health System, St. John Hospital, Wayne State University in Michigan and University of Illinois in Chicago access to a dynamic pool of well characterized high risk kidney disease patients and their biological specimens to conduct high caliber translational research.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Retention:   Samples With DNA
Description:

Urine, blood and renal tissue, if available

Non-Probability Sample

Nephrology clinic patients and community members

  • Chronic Kidney Disease
  • Glomerulopathy
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  • Chronic Kidney Disease Cohort
  • Matched Control Group
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1500
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Inclusion Criteria:

  • persons of any age who have chronic kidney disease (abnormally high protein in urine or reduced kidney function determined by blood tests)
  • a small number of people without chronic kidney disease

Exclusion Criteria:

  • people on hemodialysis or peritoneal dialysis
  • people who have had a kidney transplant
  • people unable or unwilling to provide consent
  • women who are pregnant or nursing
  • people who have polycystic kidney disease
  • people with a hemoglobin of <9 at the time of enrollment
  • institutionalized persons
  • people currently participating in a blinded interventional clinical trial
Both
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Yes
United States
 
NCT01016613
P30 DK 081943
Yes
Frank Brosius, MD, University of Michigan Health Systems
University of Michigan
  • St. John Health System, Michigan
  • University of Illinois at Chicago
  • Wayne State University
Principal Investigator: Frank C Brosius, MD University of Michigan
Study Director: Crystal A Gadegbeku, MD University of Michigan
Study Director: Matthias Kretzler, MD University of Michigan
University of Michigan
April 2011

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