Cystic FibrosisNCT01543620
Prospective Observational Study to Evaluate Biomarkers of Aminoglycoside Nephrotoxicity in Patients With Cystic Fibrosis
An observational study of Cystic Fibrosis, run by Foundation for the National Institutes of Health at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Fibrosis
- How many people
- 150 participants
- Where
- 3 sitesUnited States
- Study dates
- Feb 2012to Jun 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: cystic fibrosis patients
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites, 3 recruiting
- Recruiting
University of Southern California
Los Angeles, California, 90033
Research Coordinator1
Research Coordinator2
- Recruiting
University of Minnesota - Cystic Fibrosis Center
Minneapolis, Minnesota, 55455
Research Coordinator1
Research Coordinator2
- Recruiting
University of Utah
Salt Lake City, Utah, 84132
Research Coordinator1
Research Coordinator2
About this study
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.
Read the 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.
- Conditions
- Cystic Fibrosis
- 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
- Medical subject headings
- Cystic Fibrosis, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with cystic fibrosis treated with aminoglycosides | Not described | |
| Patients with cystic fibrosis not treated with aminoglycosides | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2012 (estimated)
- Study startFeb 2012
- Primary completionJun 2015 (estimated)
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundation for the National Institutes of Health
- Sponsor type
- University, hospital or other
- 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 LLC, Pfizer, Critical Path Institute, Predictive Safety Testing Consortium
- Responsible party
- Sponsor
- Investigators
- Paul Beringer, PharmD, Principal investigator, University of Southern CaliforniaJoanne Billings, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01543620
- Sponsor's protocol ID
- Kidney Safety - Aminoglycoside
- Status last verified
- Jul 2014
- First submitted
- 28 Feb 2012
- Last updated
- 9 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study to Evaluate Biomarkers of Aminoglycoside Nephrotoxicity in Patients With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT01543620
- Acronym / sponsor ID
- Kidney Safety - Aminoglycoside
- Conditions
- Cystic Fibrosis
- Keywords
- kidney safety, biomarkers, serum creatinine, BUN, cystic fibrosis, head and neck cancer, renal injury, drug induced acute kidney injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Foundation for the National Institutes of HealthUniversity, hospital or other
- 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 LLC, Pfizer, Critical Path Institute, Predictive Safety Testing Consortium
- Study start
- Feb 2012
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 5 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with cystic fibrosis treated with aminoglycosides | – | – |
| Patients with cystic fibrosis not treated with aminoglycosides | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- cystic fibrosis patients
Key inclusion criteria (8 listed)
- 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:
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Beringer, PharmD principal investigator
University of Southern California
Joanne Billings, MD principal investigator
University of Minnesota
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis, run by Foundation for the National Institutes of Health at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Irene Nunes, OD, PhD ((732) 594-1137, irene_nunes@merck.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2014.