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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Foundation for the National Institutes of Health
Sponsor:
Collaborators:
University of Southern California
University of Minnesota - Clinical and Translational Science Institute
M.D. Anderson Cancer Center
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Amgen
AstraZeneca
Eli Lilly and Company
Johnson & Johnson
Merck Sharp & Dohme Corp.
Pfizer
Critical Path Institute
Predictive Safety Testing Consortium
Information provided by (Responsible Party):
Foundation for the National Institutes of Health
ClinicalTrials.gov Identifier:
NCT01543620
First received: February 28, 2012
Last updated: July 15, 2014
Last verified: July 2014
  Purpose

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.


Condition
Cystic Fibrosis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Prospective Observational Study to Evaluate Biomarkers of Aminoglycoside Nephrotoxicity in Patients With Cystic Fibrosis

Resource links provided by NLM:


Further study details as provided by Foundation for the National Institutes of Health:

Biospecimen Retention:   Samples Without DNA

urine and blood


Estimated Enrollment: 150
Study Start Date: February 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients with cystic fibrosis treated with aminoglycosides
Patients with cystic fibrosis not treated with aminoglycosides

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

cystic fibrosis patients

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01543620

Contacts
Contact: Irene Nunes, OD, PhD (732) 594-1137 irene_nunes@merck.com
Contact: Jessica Ratay, MS (301) 435-4038 jratay@fnih.org

Locations
United States, California
University of Southern California Recruiting
Los Angeles, California, United States, 90033
Contact: Research Coordinator1         
Contact: Research Coordinator2         
Principal Investigator: Paul Beringer, PharmD         
United States, Minnesota
University of Minnesota - Cystic Fibrosis Center Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Research Coordinator1         
Contact: Research Coordinator2         
Principal Investigator: Joanne Billings, MD         
Sponsors and Collaborators
Foundation for the National Institutes of Health
University of Southern California
University of Minnesota - Clinical and Translational Science Institute
M.D. Anderson Cancer Center
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Amgen
AstraZeneca
Eli Lilly and Company
Johnson & Johnson
Merck Sharp & Dohme Corp.
Pfizer
Critical Path Institute
Predictive Safety Testing Consortium
Investigators
Principal Investigator: Paul Beringer, PharmD University of Southern California
Principal Investigator: Joanne Billings, MD University of Minnesota - Clinical and Translational Science Institute
  More Information

No publications provided

Responsible Party: Foundation for the National Institutes of Health
ClinicalTrials.gov Identifier: NCT01543620     History of Changes
Other Study ID Numbers: Kidney Safety - Aminoglycoside
Study First Received: February 28, 2012
Last Updated: July 15, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Foundation for the National Institutes of Health:
cystic fibrosis
kidney safety
biomarkers
serum creatinine
BUN
head and neck cancer
renal injury
drug induced acute kidney injury
aminoglycoside
cisplatin
nephrotoxicity
biomarker qualification

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Digestive System Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Lung Diseases
Pancreatic Diseases
Pathologic Processes
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 23, 2014