Prospective Observational Study to Evaluate Biomarkers of Aminoglycoside Nephrotoxicity in Patients With Cystic Fibrosis
NCT ID: NCT01543620
Last Updated: 2014-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
150 participants
OBSERVATIONAL
2012-02-29
2015-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Patients with cystic fibrosis treated with aminoglycosides
No interventions assigned to this group
Patients with cystic fibrosis not treated with aminoglycosides
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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University of Southern California
OTHER
University of Minnesota
OTHER
M.D. Anderson Cancer Center
OTHER
Dana-Farber Cancer Institute
OTHER
Brigham and Women's Hospital
OTHER
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Amgen
INDUSTRY
AstraZeneca
INDUSTRY
Eli Lilly and Company
INDUSTRY
Johnson & Johnson
INDUSTRY
Merck Sharp & Dohme LLC
INDUSTRY
Pfizer
INDUSTRY
Critical Path Institute
UNKNOWN
Predictive Safety Testing Consortium
UNKNOWN
Foundation for the National Institutes of Health
OTHER
Responsible Party
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Principal Investigators
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Paul Beringer, PharmD
Role: PRINCIPAL_INVESTIGATOR
University of Southern California
Joanne Billings, MD
Role: PRINCIPAL_INVESTIGATOR
University of Minnesota
Locations
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University of Southern California
Los Angeles, California, United States
University of Minnesota - Cystic Fibrosis Center
Minneapolis, Minnesota, United States
University of Utah
Salt Lake City, Utah, United States
Countries
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Central Contacts
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Facility Contacts
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Research Coordinator1
Role: primary
Research Coordinator2
Role: backup
Research Coordinator1
Role: primary
Research Coordinator2
Role: backup
Research Coordinator1
Role: primary
Research Coordinator2
Role: backup
Other Identifiers
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Kidney Safety - Aminoglycoside
Identifier Type: -
Identifier Source: org_study_id