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Anti-Nausea Medications for Preventing Kidney Damage

Phase 3

Recruiting

Led By Melanie Joy, PharmD, PhD

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18-80 years

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 days

Awards & highlights

Study Summary

This trial is studying if drugs given to treat cisplatin-related nausea can also help protect the kidneys from damage, if cisplatin levels in the body influence kidney damage, and if a person's genes can make them more or less likely to experience kidney damage from cisplatin therapy.

Who is the study for?

This trial is for adults aged 18-80 who are prescribed cisplatin for treatment and have healthy kidneys (eGFR > 60 ml/min^2) and liver. Participants should not be pregnant, breastfeeding, or have a history of heavy alcohol use. They must avoid grapefruit juice, alcohol, certain medications, and herbal supplements before the trial.Check my eligibility

What is being tested?

The study tests if nausea drugs like Palonosetron, Granisetron, Ondansetron affect kidney damage from cisplatin therapy. It also examines how cisplatin levels in the body and genetic factors contribute to kidney injury risk.See study design

What are the potential side effects?

Potential side effects may include headaches, constipation or diarrhea related to anti-nausea medications. Since these drugs target specific receptors involved in vomiting reflexes, they generally have fewer side effects than other types.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 80 years old.

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I am prescribed cisplatin at a dose higher than 25 mg/m^2.

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I have never had an organ transplant or kidney dialysis.

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My liver tests are within normal limits.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Kidney Injury with Cisplatin and 5-HT3 Antagonist Antiemetic Regimen as Assessed by a 1.5 fold increase in a Biomarker Panel

Antiemetics

Secondary outcome measures

Targeted Genetic Polymorphisms are Associated with Risk of Kidney Injury Due to Cisplatin and 5-HT3 Antagonist Antiemetic Regimen as Assessed by a 1.5 fold increase in a Biomarker Panel

Trial Design

3Treatment groups

Experimental Treatment

Group I: PalonosetronExperimental Treatment1 Intervention

Participants randomized to an antiemetic regimen containing palonosetron 0.25 mg IV and evaluated for cisplatin toxicity after the first dose of cisplatin.

Group II: OndansetronExperimental Treatment1 Intervention

Participants randomized to an antiemetic regimen containing ondansetron 8 mg oral or IV and evaluated for cisplatin toxicity after the first dose of cisplatin.

Group III: GranisetronExperimental Treatment1 Intervention

Participants randomized to an antiemetic regimen containing granisetron 2 mg oral or IV and evaluated for cisplatin toxicity after the first dose of cisplatin.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Palonosetron

FDA approved

Granisetron

FDA approved

Ondansetron

FDA approved

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute of General Medical Sciences (NIGMS)NIH

269 Previous Clinical Trials

247,050 Total Patients Enrolled

University of Colorado, DenverLead Sponsor

1,738 Previous Clinical Trials

2,149,454 Total Patients Enrolled

Memorial Sloan Kettering Cancer CenterOTHER

1,936 Previous Clinical Trials

588,817 Total Patients Enrolled

Media Library

Kidney Damage Research Study Groups: Palonosetron, Ondansetron, Granisetron

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What medicinal purpose does Palonosetron typically serve?

"Palonosetron is typically prescribed to combat the side effects of radiation therapy, however it has also been used for pharmacotherapy-induced nausea and vomiting as well as pruritus."

Answered by AI

Does this investigation have an age limit, and if so, what is it?

"As per the established guidelines, only individuals aged 18 to 80 are eligible for enrollment in this trial."

Answered by AI

Who do you consider the ideal participants for this clinical experiment?

"This clinical trial is enrolling 72 individuals aged 18-80 who have nephrotoxicity. In addition to this, potential participants must abstain from grapefruit juice and alcohol consumption within the week prior, not exceed 14 drinks per week in alcoholic beverages historically, never had an organ transplant or used kidney dialysis, be willing to comply with the study's protocols, neither pregnant nor lactating at present time and not make changes to their chronic medications for two weeks."

Answered by AI

Has Palonosetron been studied through any prior research endeavors?

"Palonosetron was initially evaluated at Harbin Medical University in 2014 and there have been 314 finished studies since. Currently, 29 trials are active with a considerable portion of them taking place in Denver, Colorado."

Answered by AI

Is enrollment in this trial currently available to prospective participants?

"Affirmative. Clinicaltrials.gov contains information indicating that this trial, which went public on June 26th 2019, is actively seeking participants. 72 people have to be enrolled between 2 medical sites."

Answered by AI

What is the magnitude of individuals involved in this research endeavor?

"Affirmative. Evident from clinicaltrials.gov, this research endeavour is currently in the process of recruiting test subjects. The study was first launched on June 26th 2019 with its most recent update on October 31st 2022 and requires 72 participants to join across two clinics."

Answered by AI

Recent research and studies

International Journal of Molecular SciencesJournal

Pharmacogenomic Variants May Influence the Urinary Excretion of Novel Kidney Injury Biomarkers in Patients Receiving Cisplatin

Chang, Cara, Yichun Hu, Susan Hogan, Nickie Mercke, Madeleine Gomez, Cindy O’Bryant, Daniel Bowles, et al.. 2017. “Pharmacogenomic Variants May Influence the Urinary Excretion of Novel Kidney Injury Biomarkers in Patients Receiving Cisplatin”. International Journal of Molecular Sciences. MDPI AG. doi:10.3390/ijms18071333.

Experimental Biology and MedicineJournal

Urinary Protein Biomarkers of Kidney Injury in Patients Receiving Cisplatin Chemotherapy

George, Blessy, Melanie S Joy, and Lauren M Aleksunes. 2017. “Urinary Protein Biomarkers of Kidney Injury in Patients Receiving Cisplatin Chemotherapy”. Experimental Biology and Medicine. SAGE Publications. doi:10.1177/1535370217745302.

Advanced Drug Delivery ReviewsJournal

Xenobiotic Transporters and Kidney Injury

George, Blessy, Dahea You, Melanie S. Joy, and Lauren M. Aleksunes. 2017. “Xenobiotic Transporters and Kidney Injury”. Advanced Drug Delivery Reviews. Elsevier BV. doi:10.1016/j.addr.2017.01.005.

Clinical Pharmacology & TherapeuticsJournal