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Cisplatin

Dipeptidyl-Peptidase IV Inhibitors

Gemigliptin 100mg daily in two divided doses for 8 days starting from one day before cisplatin-treatment

Placebo 100mg daily in two divided doses for 8 days starting from one day before cisplatin-treatment

Gemigliptin 100mg in 2 divided doses plus cisplatin

Gemigliptin

Placebo

All patients will receive intravenous cisplatin

Ki Young Na

Hyunjin Cho

Ki Young Na, MD PhD

Cisplatin is a potent chemotherapeutic agent, however, its nephrotoxicity manifested by acute kidney injury (AKI) often limits applicability. Dipeptidylpeptidase-4 (DPP4) inhibitors are well known to improve glucose intolerance by augmentation of endogenous glucagon like peptide (GLP-1) and glucose-dependent insulinotropic peptide (GIP). DPP4 inhibitor also has the potential anti-apoptotic and renoprotective effect in a mouse model of cisplatin-induced AKI. This is a single-center, randomized, double-blind, parallel-group, placebo-controlled, prospective study to investigate the renoprotective effect of DPP4 inhibitor on cisplatin-induced AKI. A total 182 patients, who are scheduled to treat with cisplatin, will be recruited and randomly assigned to either Gemigliptin or placebo groups. Subjects will take study drugs for 8 days starting from one day before cisplatin treatment. Serum creatinine (Cr) and estimated glomerular filtration rate (eGFR) will be measured at 7 days after cisplatin treatment.

This study will investigate possible renoprotective effects of DPP4 inhibitor on cisplatin induced acute kidney injury.

Effects of DPP4 Inhibitor on Cisplatin Induced Acute Kidney Injury

Effect of DPP4 Inhibitors on Cisplatin-induced Acute Kidney Injury

* Increase in sCr by ≥ 0.3 mg/dl
* Increase in sCr to ≥ 1.5 times baseline
* Decrease in eGFR to ≥ 25%

All subjects receive Gemigliptin or placebo at a total dose of 100mg (50mg twice a day) for 8 consecutive days, serum creatinine will be measured.

Change of serum creatinine from baseline to 7 days after cisplatin treatment.

Change of glomerular filtration rate calculated by the Chronic Kidney Disease Epidemiology Collaboration equations (CKD EPI) from baseline to 7 days after cisplatin treatment.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Effects of DPP4 Inhibitor on Cisplatin Induced Acute Kidney Injury	NCT02250872	Cancer Cisplatin Adver...	Gemigliptin Placebo Cisplatin	18 Years - 70 Years	Seoul National University Bundang Hospital
Effects of DPP4 Inhibitor on Cisplatin Induced Acute Kidney Injury	NCT02250872	Cancer Cisplatin Adver...	Gemigliptin Placebo Cisplatin	18 Years - 70 Years	Seoul National University Bundang Hospital

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