Clinical trial · Observational
Prospective Observational Study to Evaluate Biomarkers of Aminoglycoside Nephrotoxicity in Patients With Cystic Fibrosis
NCT01543620CI-TRIAL-00016305unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cystic Fibrosis | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Patients with cystic fibrosis treated with aminoglycosides
- label
- Patients with cystic fibrosis not treated with aminoglycosides
Primary outcomes (0)
[]Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: 1. Males and females ≥ 18 years of age. 2. 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. 3. Hospitalized and initiated on systemic antibiotic therapy for treatment of an acute pulmonary exacerbation. 4. Willingness and ability to comply with study procedures and study restrictions. 5. Ability to provide written informed consent. Exclusion criteria: 1. Chronic kidney disease defined by microalbuminuria (\> 30 mcg/mg creatinine) or eGFR \< 60 mL/min/1.73m2. 2. Receiving medications known to alter the tubular secretion of creatinine (e.g. trimethoprim, cimetidine). 3. Hospitalized for treatment of an acute pulmonary exacerbation or received intravenous aminoglycoside antibiotics within 3-months of study entry.
References
Publications (0)
Data not yet available
No reference posted for this study.