Effects of DPP4 Inhibitor on Cisplatin Induced Acute Kidney Injury

Seoul National University

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Cisplatin Adverse Reaction; Cancer

Treatments: Drug: Cisplatin; Drug: Placebo; Drug: Gemigliptin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02250872

B1408264002

Details and patient eligibility

About

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.

Full description

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

Enrollment: 182 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

182 participants in 2 patient groups, including a placebo group

Experimental: Gemigliptin and Cisplatin

Active Comparator group

Description:

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

Treatment:

Drug: Gemigliptin

Drug: Cisplatin

Control arm

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Drug: Cisplatin