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




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Trials

, 16:239

First Online: 29 May 2015Received: 14 January 2015Accepted: 21 May 2015DOI: 10.1186-s13063-015-0772-4

Cite this article as: Baek, S.H., Kim, S.H., Kim, J.W. et al. Trials 2015 16: 239. doi:10.1186-s13063-015-0772-4

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.

KeywordsAcute kidney injury Cisplatin DPP4 inhibitor Nephrotoxicity AbbreviationsAKIAcute kidney injury

DPP4Dipeptidyl peptidase-4

GLP-1Glucagon-like peptide-1

NSAIDNonsteroidal anti-inflammatory drug

SCrSerum creatinine

eGFREstimated glomerular filtration rate

PPPer protocol

ITTIntention-to treat

CYP3A4Cytochrome P450 3A4

OCT2Organic cation transporter

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

Fuente: https://link.springer.com/







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