A Prospective Observational Study to Evaluate Acute Kidney Injury Biomarkers In Patients Receivin… (NCT01936376) | Clinical Trial Compass
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A Prospective Observational Study to Evaluate Acute Kidney Injury Biomarkers In Patients Receiving First Cycle of Cisplatin Chemotherapy for Head and Neck Cancers
United States150 participantsStarted 2012-09
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Males and females ≥ 18 years of age
✓. Diagnosis of head \& neck cancer and confirmation that patient is due to receive a 1st cycle of cisplatin (75-100 mg/m2/cycle) chemotherapy either:
✓. Willingness and ability to comply with study procedures and study restrictions
✓. Ability to provide written informed consent
✓. Males and females ≥ 18 years of age
✓. Diagnosis of head \& neck cancer or similar condition such as an upper body, localised malignancy. These control patients will be scheduled to receive a non-nephrotoxic treatment modality (e.g. local radiotherapy alone)
✓. Willingness and ability to comply with study procedures and study restrictions
✓. Ability to provide written informed consent
Exclusion criteria
✕. Chronic kidney disease defined by eGFR \<60 mL/min/1.73m2. Patients with normal eGFR but persistent dipstick proteinuria require urinary albumin measurement: those with microalbuminuria (\>30 mcg/mg creatinine) will be excluded
✕. Patients currently receiving other potentially nephrotoxic agents (i.e. chronic use of high dose NSAIDs, intravenous aminoglycosides, intravenous colistin, intravenous vancomycin, or ACEi)
✕. Any major surgery (i.e. high risk of acute kidney injury) in the previous month
What they're measuring
1
biomarker change from baseline
Timeframe: up to 3 weeks
Trial details
NCT IDNCT01936376
SponsorFoundation for the National Institutes of Health