Recruiting

Biomarkers Evaluation

Sponsor:

NIH

Code:

NCT01543620

Conditions

Cystic Fibrosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Cystic Fibrosis

Study ID

NCT01543620

Start date

Feb, 2012

Status verified date

Jul, 2014

Completion date

Jun, 2015

Anticipated

Primary completion date

Jun, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Arms

Patients with cystic fibrosis treated with aminoglycosides

Patients with cystic fibrosis not treated with aminoglycosides

Central Contacts and Locations

Central contacts

Locations

University of Southern California

Recruiting

Los Angeles, California, United States, 90033

Principal Investigator:

Paul Beringer, PharmD

University of Minnesota - Cystic Fibrosis Center

Recruiting

Minneapolis, Minnesota, United States, 55455

Principal Investigator:

Joanne Billings, MD

University of Utah

Recruiting

Salt Lake City, Utah, United States, 84132

Principal Investigator:

Dave Young, PharmD

More Information

Sponsor

Foundation for the National Institutes of Health

Last update posted

Dec 9, 2014

Last verified

Jul, 2014

Keywords

  • kidney safety
  • biomarkers
  • serum creatinine
  • BUN
  • cystic fibrosis
  • head and neck cancer
  • renal injury
  • drug induced acute kidney injury
  • aminoglycoside
  • cisplatin
  • nephrotoxicity
  • biomarker qualification

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Foundation for the National Institutes of Health on 2014-12-09.