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Common Anti-Nausea drugs under scrutiny for kidney risk during chemo

NCT ID NCT03817970

Knowledge-focused Sponsor: University of Colorado, Denver Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 17, 2026 · Last updated Sep 18, 2026 · Updated 1 time

Summary

Researchers at the University of Colorado are studying whether anti-nausea drugs given with cisplatin chemotherapy affect the risk of kidney injury. The trial enrolls 45 adults receiving cisplatin. It measures kidney injury biomarkers and cisplatin levels in urine, and examines whether a person's genes influence kidney harm.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
granisetron, ondansetron, and palonosetron, anti-nausea drugs given with cisplatin chemotherapy
What this could lead to
If researchers learn how these anti-nausea drugs affect cisplatin kidney harm, doctors could adjust treatment to protect kidneys during chemotherapy.
What could go wrong
This small study observes patients and cannot prove cause and effect. Kidney injury from cisplatin may occur regardless of anti-nausea drug choice, and genetic factors may complicate the picture.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

45 people

The number who actually took part.

Started

Nov 2019

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

acute kidney injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Nephrotoxicity

Contacts and locations

Locations

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • UCHealth-Metro Denver

    Denver, Colorado, 80045, United States

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