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
  Purpose

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.


Condition
Chronic Kidney Disease
Glomerulopathy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Phenotyping Resource and Biobank Core of the Michigan O'Brien Renal Center

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Biospecimen Retention:   Samples With DNA

Urine, blood and renal tissue, if available


Estimated Enrollment: 1500
Study Start Date: January 2009
Groups/Cohorts
Chronic Kidney Disease Cohort
Matched Control Group

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Nephrology clinic patients and community members

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01016613

Locations
United States, Illinois
University of Illinois at Chicago Recruiting
Chicago, Illinois, United States, 60612
Contact: Alberto Cabrales    312-996-2937    acabrals@uic.edu   
Principal Investigator: Kalyani Perumal, MD         
United States, Michigan
University of Michigan Health System Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Jennifer J Hawkins, MPH    734-615-8304    jenjoyce@med.umich.edu   
Contact: Chrysta Lienczewski, BS    734-615-5021    boridley@med.umich.edu   
Principal Investigator: Crystal A Gadegbeku, MD         
St. John's Health System Recruiting
Detroit, Michigan, United States, 48236
Contact: Sherry Gasko, RN, BSN    313-886-8787 ext 1264    Sherry.Gasko@stjohn.org   
Contact: Tina Cavendish    313-886-8787 ext 1266    tcavendish@scsp.net   
Principal Investigator: Susan Steigerwalt, MD         
Wayne State University Recruiting
Detroit, Michigan, United States, 48201
Contact: Carol Muzyk, CCRP    313-745-2378    cmuzyk@med.wayne.edu   
Principal Investigator: Kalyani Mehta, MD         
Sponsors and Collaborators
University of Michigan
St. John Health System, Michigan
University of Illinois at Chicago
Wayne State University
Investigators
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
  More Information

No publications provided

Responsible Party: Frank Brosius, MD, University of Michigan Health Systems
ClinicalTrials.gov Identifier: NCT01016613     History of Changes
Other Study ID Numbers: P30 DK 081943
Study First Received: November 18, 2009
Last Updated: April 7, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
chronic kidney disease
glomerulonephritis
proteinuria
nephrotic syndrome
nephropathy
biobank

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on April 14, 2014