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

NCT ID: NCT01016613

Last Updated: 2024-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

1800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-01-31

Study Completion Date

2030-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Kidney Disease Glomerulopathy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Chronic Kidney Disease Cohort

chronic kidney disease patients with any type of kidney disease

No interventions assigned to this group

Matched Control Group

Healthy controls

No interventions assigned to this group

Trios

First degree relatives of pediatric chronic kidney disease cohort members

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

St. John Health System, Michigan

OTHER

Sponsor Role collaborator

Temple University

OTHER

Sponsor Role collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Markus Bitzer

Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Subramanium Pennathur, MBBS

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Crystal A Gadegbeku, MD

Role: STUDY_DIRECTOR

The Cleveland Clinic

Matthias Kretzler, MD

Role: STUDY_DIRECTOR

University of Michigan

Markus Bitzer, MD

Role: STUDY_DIRECTOR

University of Michigan

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Michigan Health System

Ann Arbor, Michigan, United States

Site Status RECRUITING

Wayne State University

Detroit, Michigan, United States

Site Status COMPLETED

St. John's Health System

Detroit, Michigan, United States

Site Status COMPLETED

Levine Children's Hospital

Charlotte, North Carolina, United States

Site Status COMPLETED

Temple University

Philadelphia, Pennsylvania, United States

Site Status COMPLETED

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Chrysta Lienczewski

Role: CONTACT

734-615-5021

Markus Bitzer, MD

Role: CONTACT

734-763-4688

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Chrysta Lienczewski

Role: primary

734-615-5021

Sana Shaikh, MD

Role: backup

734-736-4273

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

P30DK081943

Identifier Type: NIH

Identifier Source: secondary_id

View Link

P30DK081943

Identifier Type: NIH

Identifier Source: org_study_id

View Link

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Chronic Kidney Disease Screening
NCT07153432 RECRUITING
Kidney Disease After COVID-19
NCT05328986 COMPLETED
Biorepository to Support Research in Kidney Diseases
NCT04343417 ENROLLING_BY_INVITATION