Status:
ACTIVE_NOT_RECRUITING
Cisplatin Disposition and Kidney Injury
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
Memorial Sloan Kettering Cancer Center
Rutgers University
Conditions:
Nephrotoxicity
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
This study is being done to determine 1) whether drugs to treat cisplatin-related nausea can influence harm to the kidneys, 2) whether cisplatin levels in the body can influence the risk of harm to th...
Detailed Description
Cisplatin (cis-diamminedichloroplatinum, Platinol®) is commonly utilized in chemotherapy regimens for the treatment of solid cancers including lung, head and neck, and cervix. Its main mechanism of ac...
Eligibility Criteria
Inclusion
- Male or female patient prescribed cisplatin at a dose of \>25mg/m\^2
- Age 18-80 years
- Hemoglobin \>/=9 g/dl
- No consumption of grapefruit juice or alcohol within 7 days
- No history of alcohol consumption of \>14 drinks/week
- No history of organ transplantation or kidney dialysis
- Willingness to comply with study
- Not pregnant or lactating
- No changes in chronic medications within 2 weeks
- Estimated glomerular filtration rate (eGFR) \> 60 ml/min\^2
- Normal liver function (ALT and AST \<2x ULN)
Exclusion
- Diagnosis of kidney cancer
- Previous exposure to platinum-based chemotherapy with the exception of one previous dose as part of the current course
- Herbal supplement use beyond marijuana
- Exposure to other known nephrotoxins (including contrast agents) within the previous 2 weeks
- Severe gastrointestinal disease with fluid losses
- Diagnosis of a rapidly progressive glomerulonephritis
- Allergy or contraindication to 5-HT3 Antagonists
Key Trial Info
Start Date :
November 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT03817970
Start Date
November 15 2019
End Date
December 31 2027
Last Update
August 11 2025
Active Locations (2)
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1
UCHealth-Metro Denver
Denver, Colorado, United States, 80045
2
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065