Cisplatin Disposition and Kidney Injury

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    72
  • sponsor
    University of Colorado, Denver
Updated on 25 January 2021

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.

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 action is through binding of DNA to form cross-links, leading to arrest of DNA synthesis and replication. A major adverse consequence of cisplatin therapy is acute kidney injury (AKI). It is reported that between 30 and 38 percent of patients develop signs of nephrotoxicity (toxicity in the kidneys) after a single cisplatin dose, despite strategies such as hydration to limit renal exposure. This is problematic for patients as kidney injury can delay further treatment and limit the total number of chemotherapy cycles received, thereby reducing the overall efficacy of cisplatin-containing regimens. Furthermore, it is apparent that cisplatin will remain a central component to the treatment of solid tumors in the foreseeable future. New approaches to identify patients at risk of acute kidney injury (AKI) and prevent its development and progression are urgently needed. Cisplatin causes nausea and vomiting, which requires treatment with 5-HT3 antagonists (5-HT3A) to control. Associations between the clinical use of the 5-HT3A antiemetic drugs and the risk of cisplatin AKI have recently been discovered. This study will interrogate relationships between 5-HT3A drugs (granisetron, ondansetron, and palonosetron) and cisplatin AKI.

Details
Condition Nephrotoxicity
Treatment ondansetron, Palonosetron, Granisetron
Clinical Study IdentifierNCT03817970
SponsorUniversity of Colorado, Denver
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 80 yrs?
Gender: Male or Female
Do you have Nephrotoxicity?
Do you have any of these conditions: Do you have Nephrotoxicity??
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
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