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All Drugs and Chemicals

Cisplatin

Irene Nunes, OD, PhD

Jessica Ratay, MS

Research Coordinator1

Research Coordinator2

Paul Beringer, PharmD

Joanne Billings, MD

Dave Young, PharmD

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.

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.

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

University of Southern California

University of Minnesota

M.D. Anderson Cancer Center

Dana-Farber Cancer Institute

Brigham and Women's Hospital

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

Amgen

AstraZeneca

Eli Lilly and Company

Johnson & Johnson

Merck Sharp & Dohme LLC

Pfizer

Critical Path Institute

Predictive Safety Testing Consortium

Foundation for the National Institutes of Health

Renal Insufficiency

Kidney Diseases

Urologic Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Stefan Sultana, MD

Sushrut Waikar, MD

Robert Haddad, MD

Bonnie Glisson, MD

Ala Abudayyeh, MD

Abdulla Salahudeen, MD

The study will be conducted at four major medical centers, including the University of Southern California, the University of Minnesota, the Dana Farber Cancer Institute, and the MD Anderson Cancer Center. 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. Cisplatin is a common chemotherapy drug taken by patients with head and neck cancer. Aminoglycosides are a common antibiotic drug taken by patients with cystic fibrosis.

A Prospective Observational Study to Evaluate Acute Kidney Injury Biomarkers In Patients Receiving First Cycle of Cisplatin Chemotherapy for Head and Neck Cancers

Critical Path Institute - Predictive Safety Testing Consortium

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Prospective Observational Study to Evaluate Biomarkers of Aminoglycoside Nephrotoxicity in Patients With Cystic Fibrosis	NCT01543620	Cystic Fibrosis		18 Years -	Foundation for the National Institutes of Health
A Prospective Observational Study to Evaluate Acute Kidney Injury Biomarkers In Patients Receiving First Cycle of Cisplatin Chemotherapy for Head and Neck Cancers	NCT01936376	Head and Neck C...		18 Years -	Foundation for the National Institutes of Health

Spots Global Cancer Trial Database for biomarker qualification