Prospective Observational Study to Evaluate Biomarkers of Aminoglycoside Nephrotoxicity in Patients With Cystic Fibrosis
Recruitment status was: Recruiting
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Prospective Observational Study to Evaluate Biomarkers of Aminoglycoside Nephrotoxicity in Patients With Cystic Fibrosis|
|Study Start Date:||February 2012|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
|Patients with cystic fibrosis treated with aminoglycosides|
|Patients with cystic fibrosis not treated with aminoglycosides|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01543620
|United States, California|
|University of Southern California|
|Los Angeles, California, United States, 90033|
|United States, Minnesota|
|University of Minnesota - Cystic Fibrosis Center|
|Minneapolis, Minnesota, United States, 55455|
|United States, Utah|
|University of Utah|
|Salt Lake City, Utah, United States, 84132|
|Principal Investigator:||Paul Beringer, PharmD||University of Southern California|
|Principal Investigator:||Joanne Billings, MD||University of Minnesota - Clinical and Translational Science Institute|