Effects of DPP4 Inhibitor on Cisplatin Induced Acute Kidney Injury
Conditions
Cancer - Cisplatin Adverse Reaction
Conditions: official terms
Acute Kidney Injury
Conditions: Keywords
Cisplatin, Nephrotoxicity, Gemigliptin, DPP4 inhibitor
Study Type
Interventional
Study Phase
Phase 2/Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
Intervention
Name: Gemigliptin Type: Drug
Name: Placebo Type: Drug
Name: Cisplatin Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 70 Years
Minimum Age: 18 Years
Gender: Both
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
Location
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, Korea, Republic of
Status: Recruiting
Contact: Hyunjin Cho - 82 31 787 7030
Start Date
December 2014
Completion Date
October 2016
Sponsors
Seoul National University Bundang Hospital
Source
Seoul National University Bundang Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page