"Nephrology Research BioBank"
|First Received Date ICMJE||September 26, 2006|
|Last Updated Date||November 13, 2012|
|Start Date ICMJE||September 2006|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00381121 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||"Nephrology Research BioBank"|
|Official Title ICMJE||Michigan Nephrology Research BioBank for Molecular Analysis of Renal Disease "Nephrology Research BioBank"|
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.
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.
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.
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.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Observational Model: Cohort
Time Perspective: Prospective
|Target Follow-Up Duration||Not Provided|
|Biospecimen||Retention: Samples With DNA
Tissue, blood, urine
|Sampling Method||Non-Probability Sample|
Renal disease patients undergoing diagnostic workup
|Condition ICMJE||Chronic Kidney Disease|
|Intervention ICMJE||Procedure: Kidney and/or Pancreas biopsy
Clinical care biopsies surplus tissue used for study
|Study Group/Cohort (s)||Kidney disease cohort
Intervention: Procedure: Kidney and/or Pancreas biopsy
|Publications *||Schmid H, Henger A, Kretzler M. Molecular approaches to chronic kidney disease. Curr Opin Nephrol Hypertens. 2006 Mar;15(2):123-9. Review.|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||420|
|Estimated Completion Date||August 2056|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Accepts Healthy Volunteers||No|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00381121|
|Other Study ID Numbers ICMJE||HUM 4729|
|Has Data Monitoring Committee||No|
|Responsible Party||Matthias Kretzler, University of Michigan|
|Study Sponsor ICMJE||University of Michigan|
|Collaborators ICMJE||Not Provided|
|Information Provided By||University of Michigan|
|Verification Date||November 2012|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP