Effects of DPP4 Inhibitor on Cisplatin Induced Acute Kidney Injury

Phase 2

• Conditions: Cancer; Cisplatin Adverse Reaction
• Interventions: Drug: Placebo; Drug: Gemigliptin; Drug: Cisplatin

• Registration Number: NCT02250872
• Lead Sponsor: Seoul National University Bundang Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2014-09-24
• Study First Submitted QC: 2014-09-24
• Study First Posted: 2014-09-26
• Study Start: 2014-12
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-18
• Last Update Posted: 2016-04-20
• Primary Completion: 2018-02
• Study Completion: 2018-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 182

Inclusion Criteria

• age > 18 years
• cancer patients treated with intravenous cisplatin
• written consent

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control arm	Placebo	Placebo 100mg daily in two divided doses for 8 days starting from one day before cisplatin-treatment
Control arm	Cisplatin	Placebo 100mg daily in two divided doses for 8 days starting from one day before cisplatin-treatment
Experimental: Gemigliptin and Cisplatin	Gemigliptin	Gemigliptin 100mg daily in two divided doses for 8 days starting from one day before cisplatin-treatment
Experimental: Gemigliptin and Cisplatin	Cisplatin	Gemigliptin 100mg daily in two divided doses for 8 days starting from one day before cisplatin-treatment

Primary Outcome Measures

Name	Time	Method
Incidence of acute kidney injury defined as any of the followings	up to 7 days	* 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.

Secondary Outcome Measures

Name	Time	Method
delta eGFR	up to 7 days	Change of glomerular filtration rate calculated by the Chronic Kidney Disease Epidemiology Collaboration equations (CKD EPI) from baseline to 7 days after cisplatin treatment.
delta Cr	Time Frame: up to 7 days	Change of serum creatinine from baseline to 7 days after cisplatin treatment.

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of