Prospective Observational Study to Evaluate Biomarkers of Aminoglycoside Nephrotoxicity in Patients With Cystic Fibrosis
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
The goal of this clinical study is to advance the acceptance of new biomarkers designed to detect drug-induced kidney injury in clinical trials.
The Kidney Safety Project is being conducted at four major medical centers:
- University of Southern California
- University of Minnesota
- MD Anderson Cancer Center
- Dana-Farber Cancer Institute.
Blood and urine samples will be collected from patients undergoing treatment with either cisplatin or aminoglycosides, which are two different drugs known to cause injuries to the proximal tubule of the kidney. Aminoglycosides are a common antibiotic drug taken by patients with cystic fibrosis. Cisplatin is a common chemotherapy drug taken by patients with head and neck cancer.
The Aminoglycoside Study of the Kidney Safety Project is being conducted at the University of Southern California and the University of Minnesota and aims to evaluate aminoglycoside induced acute kidney injury in patients with cystic fibrosis.
The companion study, the Cisplatin Study of the Kidney Safety Project, is being conducted at the MD Anderson Cancer Center and the Dana-Farber Cancer Institute and aims to evaluate cisplatin induced acute kidney injury in patients with head and neck cancer.
The data from the Kidney Safety Project, from both the Aminoglycoside Study and the Cisplatin Study, will be combined for determination of the best biomarkers for predicting drug-induced acute kidney injury.
Tipo di studio
Iscrizione (Anticipato)
Contatti e Sedi
Contatto studio
- Nome: Irene Nunes, OD, PhD
- Numero di telefono: (732) 594-1137
- Email: irene_nunes@merck.com
Backup dei contatti dello studio
- Nome: Jessica Ratay, MS
- Numero di telefono: (301) 435-4038
- Email: jratay@fnih.org
Luoghi di studio
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California
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Los Angeles, California, Stati Uniti, 90033
- Reclutamento
- University of Southern California
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Contatto:
- Research Coordinator1
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Contatto:
- Research Coordinator2
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Investigatore principale:
- Paul Beringer, PharmD
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Minnesota
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Minneapolis, Minnesota, Stati Uniti, 55455
- Reclutamento
- University of Minnesota - Cystic Fibrosis Center
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Contatto:
- Research Coordinator1
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Contatto:
- Research Coordinator2
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Investigatore principale:
- Joanne Billings, MD
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Utah
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Salt Lake City, Utah, Stati Uniti, 84132
- Reclutamento
- University of Utah
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Contatto:
- Research Coordinator1
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Contatto:
- Research Coordinator2
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Investigatore principale:
- Dave Young, PharmD
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion criteria:
- Males and females ≥ 18 years of age.
Documentation of CF diagnosis as evidenced by one or more clinical features consistent with the CF phenotype and one or more of the following criteria:
- Sweat chloride greater than or equal to 60 mEq/L by quantitative pilocarpine iontophoresis test.
- Two well-characterized mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene; or
- Abnormal nasal potential difference.
- Hospitalized and initiated on systemic antibiotic therapy for treatment of an acute pulmonary exacerbation.
- Willingness and ability to comply with study procedures and study restrictions.
- Ability to provide written informed consent.
Exclusion criteria:
- Chronic kidney disease defined by microalbuminuria (> 30 mcg/mg creatinine) or eGFR < 60 mL/min/1.73m2.
- Receiving medications known to alter the tubular secretion of creatinine (e.g. trimethoprim, cimetidine).
- Hospitalized for treatment of an acute pulmonary exacerbation or received intravenous aminoglycoside antibiotics within 3-months of study entry.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: Caso di controllo
- Prospettive temporali: Prospettiva
Coorti e interventi
Gruppo / Coorte |
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Patients with cystic fibrosis treated with aminoglycosides
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Patients with cystic fibrosis not treated with aminoglycosides
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Collaboratori e investigatori
Collaboratori
Investigatori
- Investigatore principale: Paul Beringer, PharmD, University of Southern California
- Investigatore principale: Joanne Billings, MD, University of Minnesota
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- Kidney Safety - Aminoglycoside
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 .
Prove cliniche su Fibrosi cistica
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National Institute of Allergy and Infectious Diseases...Completato