Ignite Creation Date:
2025-12-25 @ 4:23 AM
Ignite Modification Date:
2026-01-16 @ 10:37 AM
Study NCT ID:
NCT01543620
Status:
UNKNOWN
Last Update Posted:
2014-12-09
First Post:
2012-02-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Observational Study to Evaluate Biomarkers of Aminoglycoside Nephrotoxicity in Patients With Cystic Fibrosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003550', 'term': 'Cystic Fibrosis'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'urine and blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2015-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-12-08', 'studyFirstSubmitDate': '2012-02-28', 'studyFirstSubmitQcDate': '2012-03-02', 'lastUpdatePostDateStruct': {'date': '2014-12-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'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'], 'conditions': ['Cystic Fibrosis']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'The goal of this clinical study is to advance the acceptance of new biomarkers designed to detect drug-induced kidney injury in clinical trials.\n\nThe Kidney Safety Project is being conducted at four major medical centers:\n\n* University of Southern California\n* University of Minnesota\n* MD Anderson Cancer Center\n* Dana-Farber Cancer Institute.\n\nBlood 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.\n\nThe 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.\n\nThe 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'cystic fibrosis patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. Males and females ≥ 18 years of age.\n2. 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:\n\n * Sweat chloride greater than or equal to 60 mEq/L by quantitative pilocarpine iontophoresis test.\n * Two well-characterized mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene; or\n * Abnormal nasal potential difference.\n3. Hospitalized and initiated on systemic antibiotic therapy for treatment of an acute pulmonary exacerbation.\n4. Willingness and ability to comply with study procedures and study restrictions.\n5. Ability to provide written informed consent.\n\nExclusion criteria:\n\n1. Chronic kidney disease defined by microalbuminuria (\\> 30 mcg/mg creatinine) or eGFR \\< 60 mL/min/1.73m2.\n2. Receiving medications known to alter the tubular secretion of creatinine (e.g. trimethoprim, cimetidine).\n3. Hospitalized for treatment of an acute pulmonary exacerbation or received intravenous aminoglycoside antibiotics within 3-months of study entry.'}, 'identificationModule': {'nctId': 'NCT01543620', 'briefTitle': 'Prospective Observational Study to Evaluate Biomarkers of Aminoglycoside Nephrotoxicity in Patients With Cystic Fibrosis', 'organization': {'class': 'OTHER', 'fullName': 'Foundation for the National Institutes of Health'}, 'officialTitle': 'Prospective Observational Study to Evaluate Biomarkers of Aminoglycoside Nephrotoxicity in Patients With Cystic Fibrosis', 'orgStudyIdInfo': {'id': 'Kidney Safety - Aminoglycoside'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with cystic fibrosis treated with aminoglycosides'}, {'label': 'Patients with cystic fibrosis not treated with aminoglycosides'}]}, 'contactsLocationsModule': {'locations': [{'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Research Coordinator1', 'role': 'CONTACT'}, {'name': 'Research Coordinator2', 'role': 'CONTACT'}, {'name': 'Paul Beringer, PharmD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Southern California', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Research Coordinator1', 'role': 'CONTACT'}, {'name': 'Research Coordinator2', 'role': 'CONTACT'}, {'name': 'Joanne Billings, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Minnesota - Cystic Fibrosis Center', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Research Coordinator1', 'role': 'CONTACT'}, {'name': 'Research Coordinator2', 'role': 'CONTACT'}, {'name': 'Dave Young, PharmD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'centralContacts': [{'name': 'Irene Nunes, OD, PhD', 'role': 'CONTACT', 'email': 'irene_nunes@merck.com', 'phone': '(732) 594-1137'}, {'name': 'Jessica Ratay, MS', 'role': 'CONTACT', 'email': 'jratay@fnih.org', 'phone': '(301) 435-4038'}], 'overallOfficials': [{'name': 'Paul Beringer, PharmD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Southern California'}, {'name': 'Joanne Billings, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Minnesota'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Foundation for the National Institutes of Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Southern California', 'class': 'OTHER'}, {'name': 'University of Minnesota', 'class': 'OTHER'}, {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, {'name': 'Dana-Farber Cancer Institute', 'class': 'OTHER'}, {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, {'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}, {'name': 'Amgen', 'class': 'INDUSTRY'}, {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, {'name': 'Johnson & Johnson', 'class': 'INDUSTRY'}, {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, {'name': 'Pfizer', 'class': 'INDUSTRY'}, {'name': 'Critical Path Institute', 'class': 'UNKNOWN'}, {'name': 'Predictive Safety Testing Consortium', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}