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

• ClinicalTrials.gov Identifier: NCT01016613
• Recruitment Status: Recruiting
• First Posted: November 19, 2009
• Last Update Posted: July 10, 2019
• 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)
• 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

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

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