drugset / Trial / NCT02760901

Evaluation of the Effect of Acetazolamide, Mannitol and N-acetylcysteine on Cisplatin-Induced Nephrotoxicity

NCT02760901

Phase 2 Completed 52 enrolled Ain Shams University
Non-randomizedParallel-groupOpen-labelPrevention

Summary

Cisplatin is a major anti-neoplastic drug used for the treatment of solid tumors. Its chief dose limiting side effect is nephrotoxicity. Twenty percent of patients receiving high-dose cisplatin undergo severe renal dysfunction. Acetazolamide and N-acetylcysteine (NAC) ameliorated Cisplatin-induced nephrotoxicity in rats. No study to date evaluated the protective effect of acetazolamide or NAC against cisplatin nephrotoxicity in humans. Aim of the study was to evaluate the effect of acetazolamide or NAC against cisplatin nephrotoxicity in humans compared to mannitol and to each other. Patients and methods. A total 52 patients receiving standard hydration measures for cisplatin were randomized to three groups: 20 patients receiving mannitol, 15 patients receiving acetazolamide and 17 patients receiving NAC. Patients' kidney function was monitored using serum creatinine, creatinine clearance and blood urea nitrogen; kidney injury was assessed using RIFLE criteria. Patients' liver function tests and hematological parameters were also monitored.

Timeline

Start
2013-11
Primary completion
2015-10
Completion
2016-10

Drugs

EvaluationDrugModalityDoseRoute
Comparator Acetazolamide Small molecule 250 mg
Comparator Mannitol Diagnostic / imaging agent 20 %
Comparator Mannitol Diagnostic / imaging agent 100 ml
Comparator N-acetylcysteine Small molecule 600 mg
Comparator Cisplatin Other / unclassified
Comparator sodium chloride Unknown 2500 ml

Indications