Effects of DPP4 Inhibitor on Cisplatin Induced Acute Kidney Injury

Effect of DPP4 Inhibitors on Cisplatin-induced Acute Kidney Injury

Status

UNKNOWN

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02250872

Enrollment

182

Registered

2014-09-26

Start date

2014-12-31

Completion date

2018-06-30

Last updated

2016-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Cisplatin Adverse Reaction

Keywords

Cisplatin, Nephrotoxicity, Gemigliptin, DPP4 inhibitor

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.

Interventions

DRUGGemigliptin

Gemigliptin 100mg in 2 divided doses plus cisplatin

DRUGPlacebo

100mg in 2 divided doses plus cisplatin

DRUGCisplatin

All patients will receive intravenous cisplatin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
delta Cr	Time Frame: up to 7 days	Change of serum creatinine from baseline to 7 days after cisplatin treatment.
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.

Countries

South Korea

Contacts

Primary ContactKi Young Na

82 31 787 7030

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026