drugset / Trial / NCT03817970
Cisplatin Disposition and Kidney Injury
Phase 3
Active not recruiting
45 enrolled
University of Colorado, Denver
Memorial Sloan Kettering Cancer Center · collabNational Institute of General Medical Sciences (NIGMS) · collabRutgers University · collab
RandomizedParallel-groupOpen-labelBasic science
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.
Timeline
- Start
- 2019-11-15
- Primary completion
- 2027-09-30
- Completion
- 2027-12-31
Publications
- Results 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.
- Results 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.
- Results 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Granisetron | Other / unclassified | 2 mg | Oral |
| Subject | Ondansetron | Other / unclassified | 8 mg | Oral |
| Subject | Palonosetron | Other / unclassified | 0.25 mg | Intravenous |