Effects of DPP4 Inhibitor on Cisplatin Induced Acute Kidney Injury

Cancer Clinical Trial

Official title:

Effect of DPP4 Inhibitors on Cisplatin-induced Acute Kidney Injury

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02250872
• Other study ID #: B1408264002
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: September 24, 2014
• Last updated: April 18, 2016
• Start date: December 2014
• Est. completion date: June 2018

Study information

• Verified date: April 2016
• Source: Seoul National University Bundang Hospital
• Contact: Ki Young Na
• Phone: 82 31 787 7030
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 182
• Est. completion date: June 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Kidney Injury
• Cancer
• Cisplatin Adverse Reaction

Intervention

Drug:
• Gemigliptin
Gemigliptin 100mg in 2 divided doses plus cisplatin
• Placebo
100mg in 2 divided doses plus cisplatin
• Cisplatin
All patients will receive intravenous cisplatin

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital	LG Life Sciences

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

Katagiri D, Hamasaki Y, Doi K, Okamoto K, Negishi K, Nangaku M, Noiri E. Protection of glucagon-like peptide-1 in cisplatin-induced renal injury elucidates gut-kidney connection. J Am Soc Nephrol. 2013 Dec;24(12):2034-43. doi: 10.1681/ASN.2013020134. Epub — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of acute kidney injury defined as any of the followings	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.	up to 7 days	No
Secondary	delta Cr	Change of serum creatinine from baseline to 7 days after cisplatin treatment.	Time Frame: up to 7 days	No
Secondary	delta eGFR	Change of glomerular filtration rate calculated by the Chronic Kidney Disease Epidemiology Collaboration equations (CKD EPI) from baseline to 7 days after cisplatin treatment.	up to 7 days	No

External Links

•   cisplatin
•   gemigliptin
•   U.S. FDA Resources