Recruitment

Recruitment Status
Unknown status
Estimated Enrollment
Same as current

Summary

Conditions
Cystic Fibrosis
Type
Observational
Design
Observational Model: Case-ControlTime Perspective: Prospective

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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 Ce...

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.

Tracking Information

NCT #
NCT01543620
Collaborators
  • M.D. Anderson Cancer Center
  • University of Southern California
  • University of Minnesota
  • Dana-Farber Cancer Institute
  • Pfizer
  • Critical Path Institute
  • Brigham and Women's Hospital
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • Amgen
  • AstraZeneca
  • Eli Lilly and Company
  • Predictive Safety Testing Consortium
  • Johnson & Johnson
  • Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Paul Beringer, PharmD University of Southern California Principal Investigator: Joanne Billings, MD University of Minnesota