Effects of DPP4 Inhibitor on Cisplatin Induced Acute Kidney Injury

• Status: Unknown status
• Trial end date: 2018-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Bundang Hospital
• Collaborator: LG Life Sciences
• Treatments: Cisplatin; Dipeptidyl-Peptidase IV Inhibitors

Criteria

Inclusion Criteria:

• age > 18 years

• cancer patients treated with intravenous cisplatin

• written consent

Exclusion Criteria:

• Diabetes mellitus

• Chronic kidney disease stage IV-V (eGFR < 30ml/min/1.73m2)

• History of transplantation

• History of acute kidney injury before randomization

• Use of other nephrotoxic agents such as non steroidal anti-inflammatory drugs, aminoglycosides, colistin, vancomycin

• Receiving contrast media during last 72 hours

• Liver disease (bilirubin > 2 mg/dl, transaminase levels >2.5 times the upper limit normal)

• Active infection

• Patients with high risks of dehydration owing to poor oral intake

• High blood pressure (> 180/110 mmHg despite antihypertensive medications)

• Hypersensitivity to Gemigliptin or its excipients

• Low compliance to Gemigliptin treatment