UnknownNot Applicable

Prospective Observational Study to Evaluate Biomarkers of Aminoglycoside Nephrotoxicity in Patients With Cystic Fibrosis

United States150 participantsStarted 2012-02

Plain-language summary

The project is designed to test new biomarkers that are more sensitive than the current standard in detecting injury to the proximal kidney tubule and will establish better criteria for when kidney safety concerns may halt further testing of a drug in humans.

Who can participate

Age range18 Years

SexALL

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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:
✓. 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.

Trial details

NCT IDNCT01543620

SponsorFoundation for the National Institutes of Health

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2015-06

Contact for this trial

Irene Nunes, OD, PhD

(732) 594-1137 irene_nunes@merck.com

View on ClinicalTrials.gov More Cystic Fibrosis trials