Effects of DPP4 Inhibitor on Cisplatin Induced Acute Kidney Injury

April 18, 2016 updated by: Ki Young Na, Seoul National University Bundang Hospital

Effect of DPP4 Inhibitors on Cisplatin-induced Acute Kidney Injury

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

182

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Ki Young Na
  • Phone Number: 82 31 787 7030

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
        • Recruiting
        • Seoul National University Bundang Hospital
        • Contact:
          • Hyunjin Cho
          • Phone Number: 82 31 787 7030
        • Principal Investigator:
          • Ki Young Na, MD PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Experimental: Gemigliptin and Cisplatin
Gemigliptin 100mg daily in two divided doses for 8 days starting from one day before cisplatin-treatment
Drug: Gemigliptin
Gemigliptin 100mg in 2 divided doses plus cisplatin
Other Names:
  • Zemiglo
Drug: Cisplatin
All patients will receive intravenous cisplatin
Placebo Comparator: Control arm
Placebo 100mg daily in two divided doses for 8 days starting from one day before cisplatin-treatment
Drug: Cisplatin
All patients will receive intravenous cisplatin
Drug: Placebo
100mg in 2 divided doses plus cisplatin
Other Names:
  • Identical inert tablet to mimic gemigliptin (50mg)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of acute kidney injury defined as any of the followings
Time Frame: 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.
up to 7 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Bundang Hospital

Collaborators

LG Life Sciences

Investigators

  • Principal Investigator: Ki Young Na, Seoul National University Bundang Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Anticipated)

February 1, 2018

Study Completion (Anticipated)

June 1, 2018

Study Registration Dates

First Submitted

September 24, 2014

First Submitted That Met QC Criteria

September 24, 2014

First Posted (Estimate)

September 26, 2014

Study Record Updates

Last Update Posted (Estimate)

April 20, 2016

Last Update Submitted That Met QC Criteria

April 18, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B1408264002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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