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Effects of DPP4 Inhibitor on Cisplatin Induced Acute Kidney Injury

Primary Purpose

Cancer, Cisplatin Adverse Reaction

Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Gemigliptin
Placebo
Cisplatin
Sponsored by
Seoul National University Bundang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer focused on measuring Cisplatin, Nephrotoxicity, Gemigliptin, DPP4 inhibitor

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Seoul National University Bundang HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Experimental: Gemigliptin and Cisplatin

Control arm

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

delta Cr
Change of serum creatinine from baseline to 7 days after cisplatin treatment.
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.

Full Information

First Posted
September 24, 2014
Last Updated
April 18, 2016
Sponsor
Seoul National University Bundang Hospital
Collaborators
LG Life Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02250872
Brief Title
Effects of DPP4 Inhibitor on Cisplatin Induced Acute Kidney Injury
Official Title
Effect of DPP4 Inhibitors on Cisplatin-induced Acute Kidney Injury
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2014 (undefined)
Primary Completion Date
February 2018 (Anticipated)
Study Completion Date
June 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital
Collaborators
LG Life Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Cisplatin Adverse Reaction
Keywords
Cisplatin, Nephrotoxicity, Gemigliptin, DPP4 inhibitor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
182 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental: Gemigliptin and Cisplatin
Arm Type
Active Comparator
Arm Description
Gemigliptin 100mg daily in two divided doses for 8 days starting from one day before cisplatin-treatment
Arm Title
Control arm
Arm Type
Placebo Comparator
Arm Description
Placebo 100mg daily in two divided doses for 8 days starting from one day before cisplatin-treatment
Intervention Type
Drug
Intervention Name(s)
Gemigliptin
Other Intervention Name(s)
Zemiglo
Intervention Description
Gemigliptin 100mg in 2 divided doses plus cisplatin
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Identical inert tablet to mimic gemigliptin (50mg)
Intervention Description
100mg in 2 divided doses plus cisplatin
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
All patients will receive intravenous cisplatin
Primary Outcome Measure Information:
Title
Incidence of acute kidney injury defined as any of the followings
Description
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.
Time Frame
up to 7 days
Secondary Outcome Measure Information:
Title
delta Cr
Description
Change of serum creatinine from baseline to 7 days after cisplatin treatment.
Time Frame
Time Frame: up to 7 days
Title
delta eGFR
Description
Change of glomerular filtration rate calculated by the Chronic Kidney Disease Epidemiology Collaboration equations (CKD EPI) from baseline to 7 days after cisplatin treatment.
Time Frame
up to 7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ki Young Na
Phone
82 31 787 7030
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ki Young Na
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
463-707
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyunjin Cho
Phone
82 31 787 7030
First Name & Middle Initial & Last Name & Degree
Ki Young Na, MD PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
24092928
Citation
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 2013 Oct 3.
Results Reference
result
PubMed Identifier
26021829
Citation
Baek SH, Kim SH, Kim JW, Kim YJ, Lee KW, Na KY. Effects of a DPP4 inhibitor on cisplatin-induced acute kidney injury: study protocol for a randomized controlled trial. Trials. 2015 May 29;16:239. doi: 10.1186/s13063-015-0772-4.
Results Reference
derived
Links:
URL
http://druginfo.nlm.nih.gov/drugportal/ProxyServlet?mergeData=true&objectHandle=DBMaint&APPLICATION_NAME=drugportal&actionHandle=default&nextPage=jsp/drugportal/ResultScreen.jsp&TXTSUPERLISTID=0015663271&QV1=CISPLATIN
Description
cisplatin
URL
http://druginfo.nlm.nih.gov/drugportal/ProxyServlet?mergeData=true&objectHandle=DBMaint&APPLICATION_NAME=drugportal&actionHandle=default&nextPage=jsp/drugportal/ResultScreen.jsp&TXTSUPERLISTID=0911637199&QV1=GEMIGLIPTIN
Description
gemigliptin
URL
https://clinicaltrials.gov/ct2/info/fdalinks
Description
U.S. FDA Resources

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Effects of DPP4 Inhibitor on Cisplatin Induced Acute Kidney Injury

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