Cisplatin Disposition and Kidney Injury (NCT03817970) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Cisplatin Disposition and Kidney Injury
United States72 participantsStarted 2019-11-15
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Kidney Injury with Cisplatin and 5-HT3 Antagonist Antiemetic Regimen as Assessed by a 1.5 fold increase in a Biomarker Panel
Timeframe: 3 days
2
The Effects of 5-HT3 Antagonist Antiemetic Drugs on Cisplatin Secretion