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

NCT01543620

Last updated date
Study Location
University of Southern California
Los Angeles, California, 90033, United States
Contact
(732) 594-1137

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Cystic Fibrosis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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.

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Cystic FibrosisProspective Observational Study to Evaluate Biomarkers of Aminoglycoside Nephrotoxicity in Patients With Cystic Fibrosis
NCT01543620
  1. Los Angeles, California
  2. Minneapolis, Minnesota
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Advanced Information
Descriptive Information
Brief Title Prospective Observational Study to Evaluate Biomarkers of Aminoglycoside Nephrotoxicity in Patients With Cystic Fibrosis
Official Title Prospective Observational Study to Evaluate Biomarkers of Aminoglycoside Nephrotoxicity in Patients With Cystic Fibrosis
Brief 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.
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.

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
urine and blood
Sampling Method Probability Sample
Study Population cystic fibrosis patients
Condition Cystic Fibrosis
Intervention Not Provided
Study Groups/Cohorts
  • Patients with cystic fibrosis treated with aminoglycosides
  • Patients with cystic fibrosis not treated with aminoglycosides
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: March 2, 2012)
150
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2015
Estimated Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study:All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01543620
Other Study ID Numbers Kidney Safety - Aminoglycoside
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Foundation for the National Institutes of Health
Study Sponsor Foundation for the National Institutes of Health
Collaborators
  • 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 Corp.
  • Pfizer
  • Critical Path Institute
  • Predictive Safety Testing Consortium
Investigators
Principal Investigator:Paul Beringer, PharmDUniversity of Southern California
Principal Investigator:Joanne Billings, MDUniversity of Minnesota
PRS Account Foundation for the National Institutes of Health
Verification Date July 2014