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

Cystic Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01543620
• Other study ID #: Kidney Safety - Aminoglycoside
• Status: Recruiting
• Phase: N/A
• First received: February 28, 2012
• Last updated: December 8, 2014
• Start date: February 2012
• Est. completion date: June 2015

Study information

• Verified date: July 2014
• Source: Foundation for the National Institutes of Health
• Contact: Irene Nunes, OD, PhD
• Phone: (732) 594-1137
• Email: irene_nunes[@]merck.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

1. Males and females = 18 years of age.

2. Documentation of CF diagnosis as evidenced by one or more clinical features consistent with the CF phenotype and one or more of the following criteria:

• Sweat chloride greater than or equal to 60 mEq/L by quantitative pilocarpine iontophoresis test.

• Two well-characterized mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene; or

• Abnormal nasal potential difference.

3. Hospitalized and initiated on systemic antibiotic therapy for treatment of an acute pulmonary exacerbation.

4. Willingness and ability to comply with study procedures and study restrictions.

5. Ability to provide written informed consent.

Exclusion criteria:

1. Chronic kidney disease defined by microalbuminuria (> 30 mcg/mg creatinine) or eGFR < 60 mL/min/1.73m2.

2. Receiving medications known to alter the tubular secretion of creatinine (e.g. trimethoprim, cimetidine).

3. Hospitalized for treatment of an acute pulmonary exacerbation or received intravenous aminoglycoside antibiotics within 3-months of study entry.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Locations

Country	Name	City	State
United States	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

Sponsors (15)

Lead Sponsor

Collaborator

Foundation for the National Institutes of Health

Amgen, AstraZeneca, Brigham and Women's Hospital, Critical Path Institute, Dana-Farber Cancer Institute, Eli Lilly and Company, Johnson & Johnson, M.D. Anderson Cancer Center, Merck Sharp & Dohme Corp., National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Pfizer, Predictive Safety Testing Consortium, University of Minnesota - Clinical and Translational Science Institute, University of Southern California

Country where clinical trial is conducted

United States,