NCT02250872

Effects of DPP4 Inhibitor on Cisplatin Induced Acute Kidney Injury

Effect of DPP4 Inhibitors on Cisplatin-induced Acute Kidney Injury

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 182 (estimated)
• Sponsor: Seoul National University Bundang Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Cancer
• Cisplatin Adverse Reaction

Interventions

Type	Name	Description
DRUG	Gemigliptin	Gemigliptin 100mg in 2 divided doses plus cisplatin
DRUG	Placebo	100mg in 2 divided doses plus cisplatin
DRUG	Cisplatin	All patients will receive intravenous cisplatin

Timeline

• Start date: 2014-12-01
• Primary completion: 2018-02-01
• Completion: 2018-06-01
• First posted: 2014-09-26
• Last updated: 2016-04-20

Locations

1 site across 1 country: South Korea