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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

Tracking Information
First Submitted Date November 18, 2009
First Posted Date November 19, 2009
Last Update Posted Date July 10, 2019
Study Start Date January 2009
Estimated Primary Completion Date July 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT01016613 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Clinical Phenotyping Resource and Biobank Core of the Michigan O'Brien Renal Center
Official Title Clinical Phenotyping Resource and Biobank Core of the Michigan O'Brien Renal Center
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Urine, blood and renal tissue, if available
Sampling Method Non-Probability Sample
Study Population Nephrology clinic patients and community members
Condition
  • Chronic Kidney Disease
  • Glomerulopathy
Intervention Not Provided
Study Groups/Cohorts
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: October 20, 2016)
1620
Original Estimated Enrollment
 (submitted: November 18, 2009)
1500
Estimated Study Completion Date July 2022
Estimated Primary Completion Date July 2022   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers Yes
Contacts
Contact: Chrysta Lienczewski 734-615-5021 boridley@med.umich.edu
Contact: Debbie Gipson, MD, MS 734-232-4830 dgipson@med.umich.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01016613
Other Study ID Numbers P30DK081943( U.S. NIH Grant/Contract )
P30DK081943 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Debbie Gipson, MD, University of Michigan
Study Sponsor University of Michigan
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)
Investigators
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
PRS Account University of Michigan
Verification Date July 2019