Clinical Phenotyping Resource and Biobank Core of the Michigan O'Brien Renal Center

Chronic Kidney Disease Clinical Trial

— C-PROBE  

Official title:

Clinical Phenotyping Resource and Biobank Core of the Michigan O'Brien Renal Center

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01016613
• Other study ID #: P30DK081943
• Secondary ID: P30DK081943
• Status: Recruiting
• Start date: January 2009
• Est. completion date: July 2025

Study information

• Verified date: September 2023
• Source: University of Michigan
• Contact: Chrysta Lienczewski
• Phone: 734-615-5021
• Email: boridley[@]med.umich.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1620
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Glomerulopathy
• Kidney Diseases
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
United States	University of Michigan Health System	Ann Arbor	Michigan
United States	Levine Children's Hospital	Charlotte	North Carolina
United States	St. John's Health System	Detroit	Michigan
United States	Wayne State University	Detroit	Michigan
United States	Temple University	Philadelphia	Pennsylvania

Sponsors (4)

Lead Sponsor	Collaborator
University of Michigan	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), St. John Health System, Michigan, Temple University

Country where clinical trial is conducted

United States,