"Nephrology Research BioBank"

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by University of Michigan
Sponsor:
Information provided by (Responsible Party):
Matthias Kretzler, University of Michigan
ClinicalTrials.gov Identifier:
NCT00381121
First received: September 26, 2006
Last updated: November 13, 2012
Last verified: November 2012
  Purpose

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 Intervention
Chronic Kidney Disease
Procedure: Kidney and/or Pancreas biopsy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Michigan Nephrology Research BioBank for Molecular Analysis of Renal Disease "Nephrology Research BioBank"

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Biospecimen Retention:   Samples With DNA

Tissue, blood, urine


Estimated Enrollment: 420
Study Start Date: September 2006
Estimated Study Completion Date: August 2056
Groups/Cohorts Assigned Interventions
Kidney disease cohort Procedure: Kidney and/or Pancreas biopsy
Clinical care biopsies surplus tissue used for study

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.
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Renal disease patients undergoing diagnostic workup

Criteria

Inclusion Criteria:

  • Men, women and children undergoing kidney and/or pancreas biopsy at the University of Michigan
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00381121

Contacts
Contact: Chrysta Lienczewsky 734-764-2924 boridley@med.umich.edu

Locations
United States, Michigan
University of Michigan Health System Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Chrysta Lienczewski    734-764-2924    boridley@med.umich.edu   
Contact: Matthias Kretzler, MD    734-615-5757    kretzler@umich.edu   
Principal Investigator: Matthias Kretzler, MD         
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Matthias Kretzler,, MD University of Michigan
  More Information

Publications:
Responsible Party: Matthias Kretzler, Professor of Medicine, University of Michigan
ClinicalTrials.gov Identifier: NCT00381121     History of Changes
Other Study ID Numbers: HUM 4729
Study First Received: September 26, 2006
Last Updated: November 13, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
Tissue Biobank
molecular markers
molecular pathways

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency
Pancrelipase
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014