title: Effects of a DPP4 inhibitor on cisplatin-induced acute kidney injury: study protocol for a randomized controlled trial.
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
  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.
  
  
  CONCLUSIONS
  This is the first clinical trial to investigate the effect of a DPP4 inhibitor on cisplatin-induced AKI.
  
  
  BACKGROUND
  ClinicalTrials.gov number NCT02250872, December 26, 2014.
authors.affiliation: Division of Nephrology, Department of Internal Medicine, Seoul National University Bundang Hospital, 82, Gumi-ro 173 Beon-gil, Bundang-gu, Seongnam, Gyeonggi-do, 463-707, South Korea. haya2001@hanmail.net.
authors.forename: Seon Ha
authors.initials: SH
authors.lastname: Baek
authors.affiliation: Division of Hematology and Medical Oncology, Department of Internal Medicine, Seoul National University Bundang Hospital, 82, Gumi-ro 173 Beon-gil, Bundang-gu, Seongnam, Gyeonggi-do, 463-707, South Korea. sehyunkim@snubh.org.
authors.forename: Se Hyun
authors.initials: SH
authors.lastname: Kim
authors.affiliation: Division of Hematology and Medical Oncology, Department of Internal Medicine, Seoul National University Bundang Hospital, 82, Gumi-ro 173 Beon-gil, Bundang-gu, Seongnam, Gyeonggi-do, 463-707, South Korea. whunt@daum.net.
authors.forename: Jin Won
authors.initials: JW
authors.lastname: Kim
authors.affiliation: Division of Hematology and Medical Oncology, Department of Internal Medicine, Seoul National University Bundang Hospital, 82, Gumi-ro 173 Beon-gil, Bundang-gu, Seongnam, Gyeonggi-do, 463-707, South Korea. cong1005@snubh.org.
authors.forename: Yu Jung
authors.initials: YJ
authors.lastname: Kim
authors.affiliation: Division of Hematology and Medical Oncology, Department of Internal Medicine, Seoul National University Bundang Hospital, 82, Gumi-ro 173 Beon-gil, Bundang-gu, Seongnam, Gyeonggi-do, 463-707, South Korea. hmodoctor@snubh.org.
authors.forename: Keun-Wook
authors.initials: KW
authors.lastname: Lee
authors.affiliation: Division of Nephrology, Department of Internal Medicine, Seoul National University Bundang Hospital, 82, Gumi-ro 173 Beon-gil, Bundang-gu, Seongnam, Gyeonggi-do, 463-707, South Korea. kyna@snubh.org.
authors.forename: Ki Young
authors.initials: KY
authors.lastname: Na
mesh_terms: D058186:Acute Kidney Injury / Q000139:chemically induced / Q000175:diagnosis / Q000201:enzymology / Q000517:prevention & control*; D000293:Adolescent; D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects*; D015415:Biomarkers / Q000097:blood; D002945:Cisplatin / Q000009:adverse effects*; D002985:Clinical Protocols; D003404:Creatinine / Q000097:blood; D019610:Cytoprotection; D018819:Dipeptidyl Peptidase 4 / Q000378:metabolism*; D054873:Dipeptidyl-Peptidase IV Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D005919:Glomerular Filtration Rate / Q000187:drug effects; D006801:Humans; D007668:Kidney / Q000187:drug effects* / Q000201:enzymology / Q000473:pathology / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D010881:Piperidones / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D011743:Pyrimidines / Q000009:adverse effects / Q000627:therapeutic use*; D056910:Republic of Korea; D012107:Research Design; D013997:Time Factors; D055815:Young Adult
chemical_list: D000970:Antineoplastic Agents; D015415:Biomarkers; D054873:Dipeptidyl-Peptidase IV Inhibitors; C534891:LC15-0444; D010881:Piperidones; D011743:Pyrimidines; D003404:Creatinine; C042807:DPP4 protein, human; D018819:Dipeptidyl Peptidase 4; D002945:Cisplatin