Clinical trial NCT01016613: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Kidney Disease
Glomerulopathy
Keywords: chronic kidney disease
glomerulonephritis
proteinuria
nephrotic syndrome
nephropathy
biobank
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: St. John Health System, Michigan
name: Temple University
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2009-11-19
Enrollment: 1800
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Nephrology clinic patients and community members

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.


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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
city: Detroit
country: United States
facility: St. John's Health System
state: Michigan
city: Charlotte
country: United States
facility: Levine Children's Hospital
state: North Carolina
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
Study officials:
affiliation: University of Michigan
name: Subramanium Pennathur, MBBS
role: PRINCIPAL_INVESTIGATOR
affiliation: The Cleveland Clinic
name: Crystal A Gadegbeku, MD
role: STUDY_DIRECTOR
affiliation: University of Michigan
name: Matthias Kretzler, MD
role: STUDY_DIRECTOR
affiliation: University of Michigan
name: Markus Bitzer, MD
role: STUDY_DIRECTOR
References: