Clinical trial NCT00381121: University of Michigan "Nephrology Research BioBank"
Official title: Michigan Nephrology Research BioBank for Molecular Analysis of Renal Disease "Nephrology Research BioBank"
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Kidney Disease
Keywords: Tissue Biobank
molecular markers
molecular pathways
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: amfAR, The Foundation for AIDS Research
name: Regeneron Pharmaceuticals
First posted: 2006-09-27
Enrollment: 420
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Renal disease patients undergoing diagnostic workup

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.

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 criteria: 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)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
Study officials:
affiliation: University of Michigan
name: Matthias Kretzler,, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.