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

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.

Conditions

• Cystic Fibrosis

Sponsors & Collaborators

• University of Southern California

  collaborator OTHER

• University of Minnesota

  collaborator OTHER

• M.D. Anderson Cancer Center

  collaborator OTHER

• Dana-Farber Cancer Institute

  collaborator OTHER

• Brigham and Women's Hospital

  collaborator OTHER

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  collaborator NIH

• Amgen

  collaborator INDUSTRY

• AstraZeneca

  collaborator INDUSTRY

• Eli Lilly and Company

  collaborator INDUSTRY

• Johnson & Johnson

  collaborator INDUSTRY

• Merck Sharp & Dohme LLC

  collaborator INDUSTRY

• Pfizer

  collaborator INDUSTRY

• Critical Path Institute

  collaborator UNKNOWN

• Predictive Safety Testing Consortium

  collaborator UNKNOWN

• Foundation for the National Institutes of Health

  lead OTHER

Principal Investigators

• Paul Beringer, PharmD · University of Southern California

• Joanne Billings, MD · University of Minnesota

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-02-29

Primary Completion

2015-06-30

Completion

2015-06-30

Countries

• United States

Study Locations