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

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ClinicalTrials.gov Identifier: NCT01016613
Recruitment Status : Recruiting
First Posted : November 19, 2009
Last Update Posted : July 10, 2019
Sponsor:
Collaborators:
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)
Information provided by (Responsible Party):
Debbie Gipson, MD, University of Michigan

Study Description
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Brief Summary:

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.


Condition or disease
Chronic Kidney Disease Glomerulopathy

Study Design
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Study Type : Observational
Estimated Enrollment : 1620 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Phenotyping Resource and Biobank Core of the Michigan O'Brien Renal Center
Study Start Date : January 2009
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Groups and Cohorts
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Group/Cohort
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


Outcome Measures
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Biospecimen Retention:   Samples With DNA
Urine, blood and renal tissue, if available

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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
  • adults who have polycystic kidney disease
  • institutionalized persons
  • people currently participating in a blinded interventional clinical trial
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01016613


Contacts
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Contact: Chrysta Lienczewski 734-615-5021 boridley@med.umich.edu
Contact: Debbie Gipson, MD, MS 734-232-4830 dgipson@med.umich.edu

Locations
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United States, Illinois
John H. Stroger Hospital Recruiting
Chicago, Illinois, United States, 60612
Contact: Taha Iqbal, MD    312-864-4614    tiqbal@cookcountyhhs.org   
Contact: Kalyani Perumal, MD    312-864-4601    kperumal@ccbhs.org   
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: Sana Shaikh, MD    734-736-4273    skazi@med.umich.edu   
Principal Investigator: Subramaniam Pennathur, MBBS         
Sub-Investigator: Debbie Gipson, MD, MS         
Wayne State University Recruiting
Detroit, Michigan, United States, 48201
Contact: Joe Chue, BS    313-745-2378    eh0486@wayne.edu   
Contact: Zeenat Bhat, MD    313-745-7145    eb4887@wayne.edu   
Principal Investigator: Zeenat Bhat, MD         
St. John's Health System Recruiting
Detroit, Michigan, United States, 48236
Contact: Sherry Gasko, RN, BSN    313-886-8787 ext 1264    sgasko@scsp.net   
Contact: Teresa Kozlowski    313-886-8787 ext 1218    tkozlowski@scsp.net   
Principal Investigator: Keith Bellovich, DO         
United States, North Carolina
Levine Children's Hospital Recruiting
Charlotte, North Carolina, United States, 28207
Contact: Kendra Titus    704-347-2273    Kendra.Titus@carolinashealthcare.org   
Contact: Susan Massengill, MD    704-381-8800    Susan.Massengill@carolinashealthcare.org   
Principal Investigator: Susan Massengill, MD         
United States, Pennsylvania
Temple University Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Zoe Pfeffer    201-707-4712    zoe.pfeffer@temple.edu   
Contact: Crystal A Gadegbeku, MD    215-707-0744    Crystal.Gadegbeku@tuhs.temple.edu   
Principal Investigator: Crystal A Gadegbeku, MD         
Sponsors and Collaborators
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)
Investigators
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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
More Information
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Responsible Party: Debbie Gipson, MD, Professor of Pediatrics and Communicable Diseases, University of Michigan
ClinicalTrials.gov Identifier: NCT01016613     History of Changes
Other Study ID Numbers: P30DK081943 ( U.S. NIH Grant/Contract )
P30DK081943 ( U.S. NIH Grant/Contract )
First Posted: November 19, 2009    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Debbie Gipson, MD, University of Michigan:
chronic kidney disease
glomerulonephritis
proteinuria
 nephrotic syndrome
nephropathy
biobank
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency