Prospective Observational Study to Evaluate Biomarkers of Aminoglycoside Nephrotoxicity in Patients With Cystic Fibrosis
Studieoversikt
Status
Forhold
Detaljert beskrivelse
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.
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Studiesteder
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California
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Los Angeles, California, Forente stater, 90033
- Rekruttering
- University of Southern California
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Ta kontakt med:
- Research Coordinator1
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Ta kontakt med:
- Research Coordinator2
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Hovedetterforsker:
- Paul Beringer, PharmD
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Minnesota
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Minneapolis, Minnesota, Forente stater, 55455
- Rekruttering
- University of Minnesota - Cystic Fibrosis Center
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Ta kontakt med:
- Research Coordinator1
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Ta kontakt med:
- Research Coordinator2
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Hovedetterforsker:
- Joanne Billings, MD
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Utah
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Salt Lake City, Utah, Forente stater, 84132
- Rekruttering
- University of Utah
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Ta kontakt med:
- Research Coordinator1
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Ta kontakt med:
- Research Coordinator2
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Hovedetterforsker:
- Dave Young, PharmD
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Case-Control
- Tidsperspektiver: Potensielle
Kohorter og intervensjoner
Gruppe / Kohort |
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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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Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Paul Beringer, PharmD, University of Southern California
- Hovedetterforsker: Joanne Billings, MD, University of Minnesota
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Kidney Safety - Aminoglycoside
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Kliniske studier på Cystisk fibrose
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National Institute of Allergy and Infectious Diseases...Fullført