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Spots Global Cancer Trial Database for Prospective Observational Study to Evaluate Biomarkers of Aminoglycoside Nephrotoxicity in Patients With Cystic Fibrosis

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Trial Identification

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

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

Study ID: NCT01543620

Conditions

Cystic Fibrosis

Interventions

Study Description

Brief 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.

Detailed Description: 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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Paul Beringer, PharmD

Affiliation: University of Southern California

Role: PRINCIPAL_INVESTIGATOR

Name: Joanne Billings, MD

Affiliation: University of Minnesota

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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