Clinical Phenotyping Resource and Biobank Core of the Michigan O'Brien Renal Center (C-PROBE)
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| ClinicalTrials.gov Identifier: NCT01016613 |
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Recruitment Status :
Recruiting
First Posted : November 19, 2009
Last Update Posted : June 5, 2017
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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 |
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| Chronic Kidney Disease Glomerulopathy |
| 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 2018 |
| Estimated Study Completion Date : | July 2018 |
| Group/Cohort |
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Chronic Kidney Disease Cohort
chronic kidney disease patients with any type of kidney disease
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Matched Control Group
Healthy controls
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Trios
First degree relatives of pediatric chronic kidney disease cohort members
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| Ages Eligible for Study: | Child, Adult, Senior |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
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
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
| 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, 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 | |
| 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 |
| 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: | June 5, 2017 |
| Last Verified: | June 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| 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:
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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 |