Cisplatin Disposition and Kidney Injury

NCT03817970 | Active Not Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: 18-1752.ccR01GM123330
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Nephrotoxicity

Keywords

Nephrotoxicity; Cisplatin; Kidney Injury; anti-emetics

Outcome Measures

Primary Outcomes (2)

• 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

  3 days

• 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

  3 days

Secondary Outcomes (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

  3 days

Study Arms (3)

Granisetron

EXPERIMENTAL

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

Drug: Granisetron

Ondansetron

EXPERIMENTAL

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

Drug: Ondansetron

Palonosetron

EXPERIMENTAL

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

Drug: Palonosetron

Interventions

Granisetron DRUG

An antiemetic regimen containing granisetron 2 mg oral or IV.

Also known as: Kytril

Granisetron

Ondansetron DRUG

An antiemetic regimen containing ondansetron 8 mg oral or IV.

Also known as: Zofran

Ondansetron

Palonosetron DRUG

An antiemetic regimen containing palonosetron 0.25 mg IV.

Also known as: Aloxi

Palonosetron

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Memorial Sloan Kettering Cancer Center: collaborator
• Rutgers University: collaborator
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (2)

UCHealth-Metro Denver

Denver, Colorado, 80045, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

MeSH Terms

Interventions

Granisetron; Ondansetron; Palonosetron

Intervention Hierarchy (Ancestors)

Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Indazoles; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Imidazoles; Carbazoles; Indoles; Heterocyclic Compounds, 3-Ring; Quinuclidines; Isoquinolines

Study Officials

• Melanie Joy, PharmD, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

• Edgar Jaimes, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2018
• First Posted: January 28, 2019
• Study Start: November 15, 2019
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)