Overview

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