Prospective Observational Study to Evaluate Biomarkers of Aminoglycoside Nephrotoxicity in Patients With Cystic Fibrosis
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Anticipé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Irene Nunes, OD, PhD
- Numéro de téléphone: (732) 594-1137
- E-mail: irene_nunes@merck.com
Sauvegarde des contacts de l'étude
- Nom: Jessica Ratay, MS
- Numéro de téléphone: (301) 435-4038
- E-mail: jratay@fnih.org
Lieux d'étude
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California
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Los Angeles, California, États-Unis, 90033
- Recrutement
- University of Southern California
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Contact:
- Research Coordinator1
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Contact:
- Research Coordinator2
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Chercheur principal:
- Paul Beringer, PharmD
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Minnesota
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Minneapolis, Minnesota, États-Unis, 55455
- Recrutement
- University of Minnesota - Cystic Fibrosis Center
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Contact:
- Research Coordinator1
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Contact:
- Research Coordinator2
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Chercheur principal:
- Joanne Billings, MD
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Utah
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Salt Lake City, Utah, États-Unis, 84132
- Recrutement
- University of Utah
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Contact:
- Research Coordinator1
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Contact:
- Research Coordinator2
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Chercheur principal:
- Dave Young, PharmD
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: Cas-témoins
- Perspectives temporelles: Éventuel
Cohortes et interventions
Groupe / Cohorte |
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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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Collaborateurs et enquêteurs
Collaborateurs
Les enquêteurs
- Chercheur principal: Paul Beringer, PharmD, University of Southern California
- Chercheur principal: Joanne Billings, MD, University of Minnesota
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- Kidney Safety - Aminoglycoside
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