Prospective Observational Study to Evaluate Biomarkers of Aminoglycoside Nephrotoxicity in Patients With Cystic Fibrosis
Status unconfirmed
Conditions studied: Cystic Fibrosis
In brief
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.
Key facts
- Study ID
- NCT01543620
- Run by
- Foundation for the National Institutes of Health
- People needed
- 150
- Starts
- 2012-02-01
- Expected to finish
- 2015-06-01
- Last updated by the study team
- 2014-12-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- University of Southern California — Los Angeles, California, United States (enrolling)
- University of Minnesota - Cystic Fibrosis Center — Minneapolis, Minnesota, United States (enrolling)
- University of Utah — Salt Lake City, Utah, United States (enrolling)
Full record on ClinicalTrials.gov
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