Abstract
BackgroundCisplatin is a potent chemotherapeutic agent, but its nephrotoxicity, which results in acute kidney injury (AKI), often limits its clinical application. Although many studies have attempted to target the mechanism responsible for its nephrotoxicity, no such method has been demonstrated to be effective in clinical trials. Recently, a dipeptidyl peptidase-4 (DPP4) inhibitor has been reported to have a renoprotective effect in a mouse model of cisplatin-induced AKI. Therefore, we will evaluate whether a DPP4 inhibitor protects the kidney from cisplatin-induced injury in humans.Methods/DesignThis is a single-center, prospective, randomized, double-blind, placebo-controlled trial. A total of 182 participants who are scheduled for cisplatin treatment will be enrolled and randomly assigned to receive either a DPP4 inhibitor (gemigliptin) or a placebo. Participants will take the study drugs for 8 days starting 1 day before cisplatin treatment. The primary outcome of interest is the incidence of AKI at 7 days after finishing treatment with cisplatin. The secondary outcomes include changes in serum creatinine levels and estimated glomerular filtration rates from baseline to 7 days after cisplatin treatment.DiscussionThis is the first clinical trial to investigate the effect of a DPP4 inhibitor on cisplatin-induced AKI.Trial registrationClinicalTrials.gov number NCT02250872, December 26, 2014.
Highlights
Cisplatin is a potent chemotherapeutic agent, but its nephrotoxicity, which results in acute kidney injury (AKI), often limits its clinical application
This is the first clinical trial to investigate the effect of a dipeptidyl peptidase-4 (DPP4) inhibitor on cisplatin-induced AKI
The primary outcome of interest is the incidence of AKI at 7 days after cisplatin treatment, where AKI is defined as any of the following: an increase in Serum creatinine (SCr) levels of ≥0.3 mg/dl, an increase in SCr levels of 50 % compared with baseline levels, or a decrease in the estimated glomerular filtration rate (eGFR) by ≥25 % compared with baseline [31,32,33]
Summary
Cisplatin is a potent chemotherapeutic agent, but its nephrotoxicity, which results in acute kidney injury (AKI), often limits its clinical application. We will evaluate whether a DPP4 inhibitor protects the kidney from cisplatin-induced injury in humans. Different strategies targeting each mechanism of nephrotoxicity have been evaluated for their abilities to prevent and/or attenuate renal injury [1, 15, 16]. None of these strategies has been demonstrated to be effective in clinical trials [15]
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