University of Michigan "Nephrology Research BioBank"

Sponsor
University of Michigan (Other)
Overall Status
Recruiting
CT.gov ID
NCT00381121
Collaborator
(none)
420
1
239
1.8

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    420 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Michigan Nephrology Research BioBank for Molecular Analysis of Renal Disease "Nephrology Research BioBank"
    Study Start Date :
    Sep 1, 2006
    Anticipated Primary Completion Date :
    Aug 1, 2026
    Anticipated Study Completion Date :
    Aug 1, 2026

    Arms and Interventions

    Arm Intervention/Treatment
    Kidney disease cohort

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

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      N/A and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      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)

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 University of Michigan Health System Ann Arbor Michigan United States 48109

      Sponsors and Collaborators

      • University of Michigan

      Investigators

      • Principal Investigator: Matthias Kretzler,, MD, University of Michigan

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      Responsible Party:
      Matthias Kretzler, Professor of Medicine, University of Michigan
      ClinicalTrials.gov Identifier:
      NCT00381121
      Other Study ID Numbers:
      • HUM 4729
      First Posted:
      Sep 27, 2006
      Last Update Posted:
      Jan 4, 2022
      Last Verified:
      Jan 1, 2022
      Keywords provided by Matthias Kretzler, Professor of Medicine, University of Michigan
      Additional relevant MeSH terms:

      Study Results

      No Results Posted as of Jan 4, 2022