Effects of DPP4 Inhibitor on Cisplatin Induced Acute Kidney Injury

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

182 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2018-06-30

Brief Summary

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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.

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Detailed Description

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

Conditions

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Cancer Cisplatin Adverse Reaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Experimental: Gemigliptin and Cisplatin

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

Group Type ACTIVE_COMPARATOR

Gemigliptin

Intervention Type DRUG

Gemigliptin 100mg in 2 divided doses plus cisplatin

Cisplatin

Intervention Type DRUG

All patients will receive intravenous cisplatin

Control arm

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

100mg in 2 divided doses plus cisplatin

Cisplatin

Intervention Type DRUG

All patients will receive intravenous cisplatin

Interventions

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Gemigliptin

Gemigliptin 100mg in 2 divided doses plus cisplatin

Intervention Type DRUG

Placebo

100mg in 2 divided doses plus cisplatin

Intervention Type DRUG

Cisplatin

All patients will receive intravenous cisplatin

Intervention Type DRUG

Other Intervention Names

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Zemiglo Identical inert tablet to mimic gemigliptin (50mg)

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No