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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01016613
Recruitment Status : Recruiting
First Posted : November 19, 2009
Last Update Posted : June 5, 2017
Information provided by (Responsible Party):

November 18, 2009
November 19, 2009
June 5, 2017
January 2009
July 2018   (Final data collection date for primary outcome measure)
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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

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.

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Observational Model: Cohort
Time Perspective: Prospective
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Retention:   Samples With DNA
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
    chronic kidney disease patients with any type of kidney disease
  • Matched Control Group
    Healthy controls
  • Trios
    First degree relatives of pediatric chronic kidney disease cohort members
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
July 2018
July 2018   (Final data collection date for primary outcome measure)

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
  • adults who have polycystic kidney disease
  • institutionalized persons
  • people currently participating in a blinded interventional clinical trial
Sexes Eligible for Study: All
Child, Adult, Senior
Contact: Jennifer J Hawkins, MPH 734-615-8304 jenjoyce@med.umich.edu
Contact: Debbie Gipson, MD, MS 734-232-4830 dgipson@med.umich.edu
United States
P30DK081943( U.S. NIH Grant/Contract )
P30DK081943 ( U.S. NIH Grant/Contract )
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Debbie Gipson, MD, University of Michigan
University of Michigan
  • St. John Health System, Michigan
  • John H. Stroger Hospital
  • Wayne State University
  • Temple University
  • Levine Children’s Hospital
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Subramanium Pennathur, MBBS University of Michigan
Study Director: Crystal A Gadegbeku, MD Temple University
Study Director: Matthias Kretzler, MD University of Michigan
Study Director: Debbie Gipson, MD, MS University of Michigan
University of Michigan
June 2017