University of Michigan "Nephrology Research BioBank"

NCT ID: NCT00381121

Last Updated: 2025-04-24

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

420 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-09-30

Study Completion Date

2030-08-31

Brief Summary

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

The purpose of the study is to create a Nephrology Tissue Biobank enabling the study of kidney disease from the perspectives of epidemiology, genetics and molecular biology.

Detailed Description

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

Each year chronic kidney disease (CKD) claims the lives of millions of people worldwide. Costs for patient care are in excess of 2.4 billion dollars in the US alone. At the moment most kidney diseases are of unknown etiology, are classified according to a microscopic description of the kidney tissue obtained on biopsy and are treated with non-specific therapies.

Each kidney contains millions of filter units called nephrons. The nephron consists of a glomerulus and a tubule. The glomerulus filters the blood of waste products, while retaining larger molecules that are required for the body to function properly. The filtered fluid then passes through the tubule, where salts, acids and water are regulated to keep the body in a normal metabolic state. After the filtered fluid passes through the tubule it is collected in the bladder as urine. Diseases, which affect the glomeruli or tubules result in kidney damage. Once kidney function is lost it is generally not recoverable and the only option for a patient's survival is dialysis or transplantation.

The purpose of this study is to provide a platform, which will enable researchers with different areas of expertise, to investigate the molecular markers and pathways of kidney disease and its progression. Our goal is to increase our understanding of kidney health issues and to develop new prevention and treatment strategies which will be shared with the medical community and the public.

Study description:

Individuals seen in the nephrology clinic at the University of Michigan will be eligible to enroll in this study. Their clinical data will be recorded, blood and urine samples will be collected and if a biopsy is performed as a part of their standard medical care then a small sample will be reserved for use in the study after all pathological evaluations required for patient care are completed. Biological samples will be available for biochemical, molecular biological and genetic testing and for correlation of these parameters to the individuals clinical data in future studies.

Significance:

Advances in the understanding of kidney disease may 1) provide methods of early detection of disease, 2) identify molecular markers that will help physician prescribe the most appropriate and beneficial treatments, 3) identify targets for the development of new treatments, and 4) decrease the enormous cost of caring for individuals with CKD.

Aim:

1. Create a biobank enabling the study of kidney disease from the perspectives of epidemiology, genetics and molecular biology.
2. Create a resource for the study of kidney disease, which will enable the researchers at the University of Michigan to work collaboratively toward the elucidation of the molecular pathways, which cause kidney disease.

Conditions

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

Chronic Kidney Disease

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.

Kidney disease cohort

Individuals with a clinically indicated biopsy are recruited and/or surplus tissue that remains from past clinical interventions is obtained.

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

* Men, women and children undergoing kidney and/or pancreas biopsy at the University of Michigan

Exclusion Criteria

* Individuals not willing to provide consent (for prospective biopsy)
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

amfAR, The Foundation for AIDS Research

OTHER

Sponsor Role collaborator

Regeneron Pharmaceuticals

INDUSTRY

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.

Matthias Kretzler

Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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

Matthias Kretzler,, MD

Role: PRINCIPAL_INVESTIGATOR

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

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 Lienczewsky

Role: CONTACT

734-764-2924

Facility Contacts

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

Chrysta Lienczewski

Role: primary

734-615-5021

Matthias Kretzler, MD

Role: backup

734-615-5757

References

Explore related publications, articles, or registry entries linked to this study.

Schmid H, Henger A, Kretzler M. Molecular approaches to chronic kidney disease. Curr Opin Nephrol Hypertens. 2006 Mar;15(2):123-9. doi: 10.1097/01.mnh.0000214770.11609.fb.

Reference Type BACKGROUND
PMID: 16481877 (View on PubMed)

Other Identifiers

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

HUM 4729

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

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

Study of Telitacicept in Patients With Refractory IgA Nephropathy
NCT05596708 NOT_YET_RECRUITING PHASE2/PHASE3
Nephrotic Syndrome Study Network
NCT01209000 RECRUITING
A Renal Impairment Study for PF-04965842
NCT03660241 COMPLETED PHASE1