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

December 8, 2014 updated by: Foundation for the National Institutes of Health
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.

Study Overview

Status

Unknown

Conditions

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

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90033
        • Recruiting
        • University of Southern California
        • Contact:
          • Research Coordinator1
        • Contact:
          • Research Coordinator2
        • Principal Investigator:
          • Paul Beringer, PharmD
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • University of Minnesota - Cystic Fibrosis Center
        • Contact:
          • Research Coordinator1
        • Contact:
          • Research Coordinator2
        • Principal Investigator:
          • Joanne Billings, MD
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • Recruiting
        • University of Utah
        • Contact:
          • Research Coordinator1
        • Contact:
          • Research Coordinator2
        • Principal Investigator:
          • Dave Young, PharmD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

cystic fibrosis patients

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Patients with cystic fibrosis treated with aminoglycosides
Patients with cystic fibrosis not treated with aminoglycosides

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Foundation for the National Institutes of Health

Collaborators

M.D. Anderson Cancer Center
Eli Lilly and Company
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Merck Sharp & Dohme LLC
Pfizer
Dana-Farber Cancer Institute
AstraZeneca
Johnson & Johnson
University of Southern California
Brigham and Women's Hospital
University of Minnesota
Amgen
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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Anticipated)

June 1, 2015

Study Completion (Anticipated)

June 1, 2015

Study Registration Dates

First Submitted

February 28, 2012

First Submitted That Met QC Criteria

March 2, 2012

First Posted (Estimate)

March 5, 2012

Study Record Updates

Last Update Posted (Estimate)

December 9, 2014

Last Update Submitted That Met QC Criteria

December 8, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Kidney Safety - Aminoglycoside

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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