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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Kidney Disease; Glomerulopathy

• Study Type: Observational
• Enrollment (Estimated): 1620

Contacts and Locations

• Study Contact: Name: Chrysta Lienczewski; Phone Number: 734-615-5021; Email: boridley@med.umich.edu
• Study Contact Backup: Name: Markus Bitzer, MD; Phone Number: 734-763-4688; Email: markusbi@med.umich.edu

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • University of Michigan Health System
      • Contact: Chrysta Lienczewski; Phone Number: 734-615-5021; Email: boridly@med.umich.edu
      • Contact: Sana Shaikh, MD; Phone Number: 734-736-4273; Email: skazi@med.umich.edu
      • Principal Investigator: Subramaniam Pennathur, MBBS
      • Sub-Investigator: Markus Bitzer, MD
      • Sub-Investigator: Matthias Kretzler, MD
      • Sub-Investigator: Debbie Gipson, MD, MS
    • Detroit, Michigan, United States, 48201
      • Recruiting
      • Wayne State University
      • Contact: Joe Chue, BS; Phone Number: 313-745-2378; Email: eh0486@wayne.edu
      • Contact: Zeenat Bhat, MD; Phone Number: 313-745-7145; Email: eb4887@wayne.edu
      • Principal Investigator: Zeenat Bhat, MD
    • Detroit, Michigan, United States, 48236
      • Recruiting
      • St. John's Health System
      • Contact: Sherry Gasko, RN, BSN; Phone Number: 1264 313-886-8787; Email: sgasko@scsp.net
      • Contact: Teresa Kozlowski; Phone Number: 1218 313-886-8787; Email: tkozlowski@scsp.net
      • Principal Investigator: Keith Bellovich, DO
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • Recruiting
      • Levine Children's Hospital
      • Contact: Kendra Titus; Phone Number: 704-347-2273; Email: Kendra.Titus@carolinashealthcare.org
      • Contact: Susan Massengill, MD; Phone Number: 704-381-8800; Email: Susan.Massengill@carolinashealthcare.org
      • Principal Investigator: Susan Massengill, MD
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • Recruiting
      • Temple University
      • Contact: Zoe Pfeffer; Phone Number: 201-707-4712; Email: zoe.pfeffer@temple.edu
      • Contact: Crystal A Gadegbeku, MD; Phone Number: 215-707-0744; Email: Crystal.Gadegbeku@tuhs.temple.edu
      • Principal Investigator: Crystal A Gadegbeku, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Nephrology clinic patients and community members

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

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

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Temple University; St. John Health System, Michigan
• Investigators: Principal Investigator: Subramanium Pennathur, MBBS, University of Michigan; Study Director: Crystal A Gadegbeku, MD, The Cleveland Clinic; Study Director: Matthias Kretzler, MD, University of Michigan; Study Director: Markus Bitzer, MD, University of Michigan

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: November 18, 2009
• First Submitted That Met QC Criteria: November 18, 2009
• First Posted (Estimated): November 19, 2009

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 18, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: proteinuria; chronic kidney disease; biobank; nephropathy; glomerulonephritis; nephrotic syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Renal Insufficiency; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: P30DK081943 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No