Prospective Observational Study to Evaluate Biomarkers of Aminoglycoside Nephrotoxicity in Patients With Cystic Fibrosis
NCT01543620
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Adult Trials: 18+ Years
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.
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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| 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:
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 |
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| 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 | 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:
Exclusion criteria:
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| Sex/Gender |
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| 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 |
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| Investigators |
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| PRS Account | Foundation for the National Institutes of Health | ||||||
| Verification Date | July 2014 | ||||||