Chronic Kidney DiseaseC-PROBENCT01016613
Clinical Phenotyping Resource and Biobank Core of the Michigan O'Brien Renal Center
An observational study of Chronic Kidney Disease and Glomerulopathy, run by University of Michigan at 5 sites in United States.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Disease, Glomerulopathy
- How many people
- 1,800 participants
- Where
- 5 sitesUnited States
- Study dates
- Jan 2009to Jul 2030
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Nephrology clinic patients and community members
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites
University of Michigan Health System
Ann Arbor, Michigan, 48109
Levine Children's Hospital
Charlotte, North Carolina, 28207
Wayne State University
Detroit, Michigan, 48201
St. John's Health System
Detroit, Michigan, 48236
Temple University
Philadelphia, Pennsylvania, 19140
About this study
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.
Read the detailed description
The CPROBE study, which was an individual site-specific multi-center IRB-approved longitudinal cohort study, transitioned into a Multi-Site Single IRB record study in 2020, per NIH mandate. To address this, University of Michigan IRBMED served as the IRB of record for the multiple sites. However, after COVID, sites were unwilling to continue to enroll and follow additional participants, so the only remaining active site is the University of Michigan, Ann Arbor. This study is currently operating under the IRB study number HUM00178688.
- Conditions
- Chronic Kidney Disease, Glomerulopathy
- Keywords
- chronic kidney disease, glomerulonephritis, proteinuria, nephrotic syndrome, nephropathy, biobank
- Medical subject headings
- Renal Insufficiency, Chronic, Glomerulonephritis, Proteinuria, Nephrotic Syndrome, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Data & Biorepository
The primary goal of the C-PROBE is to collect, organize and provide patient data and specimens to streamline translational discovery in partnership with the ancillary collaborators and its research base. Our strategies will be to enrich the C-PROBE cohort with additional individuals with CKD, including children and adults, and catalyze translational science productivity through the provision of data, specimens and translational research development initiatives. Participants will be followed longitudinally through the completion of the study or until death.
Measured: through study completion, 2009-2030
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2009 (estimated)
- Study startJan 2009
- Primary completionJul 2030 (estimated)
- Study completionJul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- St. John Health System, Michigan, Temple University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Renal Pre-Competitive Consortium (RPC2)
- Responsible party
- Principal investigator, Markus Bitzer, University of Michigan
- Investigators
- Subramanium Pennathur, MBBS, Principal investigator, University of MichiganCrystal A Gadegbeku, MD, Study director, The Cleveland ClinicMatthias Kretzler, MD, Study director, University of MichiganMarkus Bitzer, MD, Study director, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01016613
- Sponsor's protocol ID
- P30DK081943
- Other IDs
- P30DK081943, HUM00173830, HUM00178688
- Acronym
- C-PROBE
- Status last verified
- Oct 2026
- First submitted
- 18 Nov 2009
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No