Cisplatin Disposition and Kidney Injury

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

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 the kidneys, and 3) whether a person's genetic make-up can increase or decrease the likelihood of kidney injury due to cisplatin therapy.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Colorado, Denver
• Collaborators: Memorial Sloan Kettering Cancer Center; National Institute of General Medical Sciences (NIGMS); Rutgers University
• Treatments: Antiemetics; Cisplatin; Granisetron; Ondansetron; Palonosetron

Criteria

Inclusion Criteria:

• Male or female patient prescribed cisplatin at a dose of >25 mg/m^2

• Age 18-80 years

• Hemoglobin >/=10 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 Criteria:

• Diagnosis of kidney cancer

• Previous exposure to platinum-based chemotherapy

• Herbal supplement use beyond marijuana

• Exposure to other known nephrotoxins (including contrast agents) within the previous 2 weeks

• Concurrent use of competitive inhibitors of transport proteins (metformin, cimetidine, ranitidine, antiviral drugs, cephalosporins, topotecan, methotrexate, vinblastine)

• Severe gastrointestinal disease with fluid losses

• Diagnosis of a rapidly progressive glomerulonephritis

• Allergy or contraindication to 5-HT3 Antagonists