NCT01543620

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2012

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

February 28, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 5, 2012

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

December 9, 2014

Status Verified

July 1, 2014

Enrollment Period

3.3 years

First QC Date

February 28, 2012

Last Update Submit

December 8, 2014

Conditions

Cystic Fibrosis

Keywords

kidney safetybiomarkersserum creatinineBUNcystic fibrosishead and neck cancerrenal injurydrug induced acute kidney injuryaminoglycosidecisplatinnephrotoxicitybiomarker qualification

Study Arms (2)

Patients with cystic fibrosis treated with aminoglycosides

Patients with cystic fibrosis not treated with aminoglycosides

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

cystic fibrosis patients

You may qualify if:

  • Males and females ≥ 18 years of age.
  • 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.
  • Hospitalized and initiated on systemic antibiotic therapy for treatment of an acute pulmonary exacerbation.
  • Willingness and ability to comply with study procedures and study restrictions.
  • Ability to provide written informed consent.

You may not qualify if:

  • Chronic kidney disease defined by microalbuminuria (\> 30 mcg/mg creatinine) or eGFR \< 60 mL/min/1.73m2.
  • Receiving medications known to alter the tubular secretion of creatinine (e.g. trimethoprim, cimetidine).
  • Hospitalized for treatment of an acute pulmonary exacerbation or received intravenous aminoglycoside antibiotics within 3-months of study entry.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Southern California

Los Angeles, California, 90033, United States

RECRUITING

University of Minnesota - Cystic Fibrosis Center

Minneapolis, Minnesota, 55455, United States

RECRUITING

University of Utah

Salt Lake City, Utah, 84132, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

urine and blood

MeSH Terms

Conditions

Cystic FibrosisHead and Neck Neoplasms

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, DiseasesNeoplasms by SiteNeoplasms

Study Officials

  • Paul Beringer, PharmD

    University of Southern California

    PRINCIPAL INVESTIGATOR

  • Joanne Billings, MD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Irene Nunes, OD, PhD

CONTACT

(732) 594-1137irene_nunes@merck.com

Jessica Ratay, MS

CONTACT

(301) 435-4038jratay@fnih.org

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2012

First Posted

March 5, 2012

Study Start

February 1, 2012

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

December 9, 2014

Record last verified: 2014-07

Locations

US(3)