- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00381121
"Biobanca di ricerca nefrologica" dell'Università del Michigan
Michigan Nephrology Research BioBank per l'analisi molecolare delle malattie renali "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.
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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:
- Create a biobank enabling the study of kidney disease from the perspectives of epidemiology, genetics and molecular biology.
- 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.
Tipo di studio
Iscrizione (Stimato)
Contatti e Sedi
Contatto studio
- Nome: Chrysta Lienczewsky
- Numero di telefono: 734-764-2924
- Email: boridley@med.umich.edu
Luoghi di studio
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Michigan
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Ann Arbor, Michigan, Stati Uniti, 48109
- Reclutamento
- University of Michigan Health System
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Investigatore principale:
- Matthias Kretzler, MD
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Contatto:
- Chrysta Lienczewski
- Numero di telefono: 734-615-5021
- Email: boridley@med.umich.edu
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Contatto:
- Matthias Kretzler, MD
- Numero di telefono: 734-615-5757
- Email: kretzler@umich.edu
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Renal disease patients undergoing diagnostic workup
Descrizione
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)
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: COHORT
- Prospettive temporali: PROSPECTIVE
Coorti e interventi
Gruppo / Coorte |
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Kidney disease cohort
Individuals with a clinically indicated biopsy are recruited and/or surplus tissue that remains from past clinical interventions is obtained. |
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Matthias Kretzler,, MD, University of Michigan
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stimato)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie urogenitali
- Processi patologici
- Malattie urogenitali maschili
- Malattie renali
- Malattie urologiche
- Malattie urogenitali femminili
- Malattie urogenitali femminili e complicanze della gravidanza
- Malattia cronica
- Attributi della malattia
- Insufficienza renale
- Condizioni patologiche, segni e sintomi
- Insufficienza renale cronica
Altri numeri di identificazione dello studio
- HUM 4729
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .