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NephrotoxicityPhase 3NCT03817970

Cisplatin Disposition and Kidney Injury

A Phase 3 study testing Granisetron, Ondansetron and Palonosetron in people with Nephrotoxicity, run by University of Colorado, Denver at 2 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Nephrotoxicity
What is being tested?
Granisetron, Ondansetron and Palonosetron
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
2 sitesUnited States
Study dates
15 Nov 2019to 31 Dec 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 11Show fewer
  • 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)

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • UCHealth-Metro Denver

    Denver, Colorado, 80045

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

Other trials in United States

About this study

Official title: Drug Disposition and Nephrotoxicity

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.

Read the detailed 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.

Conditions
Nephrotoxicity
Being tested
Granisetron, Ondansetron, Palonosetron
Keywords
Nephrotoxicity, Cisplatin, Kidney Injury, anti-emetics

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GranisetronDrug

    Also called Kytril

    An antiemetic regimen containing granisetron 2 mg oral or IV.

  • OndansetronDrug

    Also called Zofran

    An antiemetic regimen containing ondansetron 8 mg oral or IV.

  • PalonosetronDrug

    Also called Aloxi

    An antiemetic regimen containing palonosetron 0.25 mg IV.

Study groups in NCT03817970
Study groupRoleWhat they receive
GranisetronExperimentalParticipants randomized to an antiemetic regimen containing granisetron 2 mg oral or IV and evaluated for cisplatin toxicity after the first dose of cisplatin.
Receives: Drug: Granisetron
OndansetronExperimentalParticipants randomized to an antiemetic regimen containing ondansetron 8 mg oral or IV and evaluated for cisplatin toxicity after the first dose of cisplatin.
Receives: Drug: Ondansetron
PalonosetronExperimentalParticipants randomized to an antiemetic regimen containing palonosetron 0.25 mg IV and evaluated for cisplatin toxicity after the first dose of cisplatin.
Receives: Drug: Palonosetron

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    The effects of 5-HT3 antagonist antiemetic drugs on cisplatin kidney injury as indicated by a 1.5 fold increase in the urinary biomarker panel values at 3 days after treatment

    Measured: 3 days

  2. The Effects of 5-HT3 Antagonist Antiemetic Drugs on Cisplatin Secretion

    The changes to cisplatin secretion in the urine (as an early biomarker for the detection of kidney injury) as indicated by a 6 mg difference between 5-HT3 Antagonist Antiemetic Drugs at 3 days after treatment

    Measured: 3 days

Secondary outcomes (1)

  1. 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

    The influence of targeted genetic polymorphisms on risk of kidney injury due to cisplatin and 5-HT3 Antagonist Antiemetic Drugs as indicated by a 1.5 fold increase in a urinary biomarker panel values at 3 days after treatment

    Measured: 3 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jan 2019
  2. Study start15 Nov 2019
  3. Primary completion30 Sep 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03817970
Sponsor's protocol ID
18-1752.cc
Other IDs
R01GM123330
Status last verified
Sep 2026
First submitted
27 Nov 2018
Last updated
17 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Wen X, Doherty C, Thompson LE, Kim C, Buckley BS, Jaimes EA, Joy MS, Aleksunes LM. Determination of unbound platinum concentrations in human plasma using ultrafiltration and precipitation methods. J Pharmacol Toxicol Methods. 2024 Jul-Aug;128:107535. doi: 10.1016/j.vascn.2024.107535. Epub 2024 Jun 30.

    PubMed 38955285

  • Thompson LE, Ghimire A, Wen X, Kim C, Doherty CL, Buckley BT, Bowles DW, O'Bryant CL, Jaimes EA, Aleksunes LM, Joy MS. Population Pharmacokinetic Model of Platinum Disposition in Cancer Patients Receiving Cisplatin and Randomized to 5-HT3 Antagonist Antiemetic Drugs. J Clin Pharmacol. 2025 Jun;65(6):763-778. doi: 10.1002/jcph.6177. Epub 2024 Dec 22.

    PubMed 39711135

  • Thompson LE, Ghimire A, Wen X, Kim C, Choza J, Doherty CL, Buckley BT, Bowles DW, O'Bryant CL, Pfister DG, Jaimes EA, Aleksunes LM, Joy MS. A Pharmacokinetic/Toxicodynamic Model of Cisplatin Nephrotoxicity Using the Kidney Injury Molecule-1 Biomarker. J Pharmacol Clin Toxicol. 2024;12(1):1184. doi: 10.47739/pharmacology1184. Epub 2024 Sep 20.

    PubMed 39726772

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Granisetron, Ondansetron and Palonosetron in people with Nephrotoxicity, run by University of Colorado, Denver at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Kidney Injury with Cisplatin and 5-HT3 Antagonist Antiemetic Regimen as Assessed by a 1.5 fold increase in a Biomarker Panel (time frame: 3 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03817970, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.

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