Effects of a DPP4 inhibitor on cisplatin-induced acute kidney injury: study protocol for a randomized controlled trial

Seon Ha Baek, Se Hyun Kim, Jin Won Kim, Yu Jung Kim, Keun-Wook Lee, Ki Young Na, Seon Ha Baek, Se Hyun Kim, Jin Won Kim, Yu Jung Kim, Keun-Wook Lee, Ki Young Na

Abstract

Background: Cisplatin 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/design: This 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.

Discussion: This is the first clinical trial to investigate the effect of a DPP4 inhibitor on cisplatin-induced AKI.

Trial registration: ClinicalTrials.gov number NCT02250872, December 26, 2014.

Figures

Fig. 1
Fig. 1
Study algorithm
Fig. 2
Fig. 2
Study schedule. Abbreviations: R, randomization; Wt, weight; Ht, height; BP, blood pressure; CBC, complete blood count; AST, aspartate aminotransferase; ALT, alanine aminotransferase; chol, cholesterol; BUN, blood urea nitrogen; Cr, creatinine; tCO2, total CO2; U/A, urinalysis; DPP4, dipeptidyl peptidase 4

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