<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02250872</url>
  </required_header>
  <id_info>
    <org_study_id>B1408264002</org_study_id>
    <nct_id>NCT02250872</nct_id>
  </id_info>
  <brief_title>Effects of DPP4 Inhibitor on Cisplatin Induced Acute Kidney Injury</brief_title>
  <official_title>Effect of DPP4 Inhibitors on Cisplatin-induced Acute Kidney Injury</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Bundang Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>LG Life Sciences</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Seoul National University Bundang Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cisplatin is a potent chemotherapeutic agent, however, its nephrotoxicity manifested by acute&#xD;
      kidney injury (AKI) often limits applicability. Dipeptidylpeptidase-4 (DPP4) inhibitors are&#xD;
      well known to improve glucose intolerance by augmentation of endogenous glucagon like peptide&#xD;
      (GLP-1) and glucose-dependent insulinotropic peptide (GIP). DPP4 inhibitor also has the&#xD;
      potential anti-apoptotic and renoprotective effect in a mouse model of cisplatin-induced AKI.&#xD;
      This is a single-center, randomized, double-blind, parallel-group, placebo-controlled,&#xD;
      prospective study to investigate the renoprotective effect of DPP4 inhibitor on&#xD;
      cisplatin-induced AKI. A total 182 patients, who are scheduled to treat with cisplatin, will&#xD;
      be recruited and randomly assigned to either Gemigliptin or placebo groups. Subjects will&#xD;
      take study drugs for 8 days starting from one day before cisplatin treatment. Serum&#xD;
      creatinine (Cr) and estimated glomerular filtration rate (eGFR) will be measured at 7 days&#xD;
      after cisplatin treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will investigate possible renoprotective effects of DPP4 inhibitor on cisplatin&#xD;
      induced acute kidney injury.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>December 2014</start_date>
  <completion_date type="Anticipated">June 2018</completion_date>
  <primary_completion_date type="Anticipated">February 2018</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of acute kidney injury defined as any of the followings</measure>
    <time_frame>up to 7 days</time_frame>
    <description>Increase in sCr by ≥ 0.3 mg/dl&#xD;
Increase in sCr to ≥ 1.5 times baseline&#xD;
Decrease in eGFR to ≥ 25%&#xD;
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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>delta Cr</measure>
    <time_frame>Time Frame: up to 7 days</time_frame>
    <description>Change of serum creatinine from baseline to 7 days after cisplatin treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>delta eGFR</measure>
    <time_frame>up to 7 days</time_frame>
    <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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">182</enrollment>
  <condition>Cancer</condition>
  <condition>Cisplatin Adverse Reaction</condition>
  <arm_group>
    <arm_group_label>Experimental: Gemigliptin and Cisplatin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Gemigliptin 100mg daily in two divided doses for 8 days starting from one day before cisplatin-treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control arm</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo 100mg daily in two divided doses for 8 days starting from one day before cisplatin-treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Gemigliptin</intervention_name>
    <description>Gemigliptin 100mg in 2 divided doses plus cisplatin</description>
    <arm_group_label>Experimental: Gemigliptin and Cisplatin</arm_group_label>
    <other_name>Zemiglo</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>100mg in 2 divided doses plus cisplatin</description>
    <arm_group_label>Control arm</arm_group_label>
    <other_name>Identical inert tablet to mimic gemigliptin (50mg)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cisplatin</intervention_name>
    <description>All patients will receive intravenous cisplatin</description>
    <arm_group_label>Control arm</arm_group_label>
    <arm_group_label>Experimental: Gemigliptin and Cisplatin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age &gt; 18 years&#xD;
&#xD;
          -  cancer patients treated with intravenous cisplatin&#xD;
&#xD;
          -  written consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diabetes mellitus&#xD;
&#xD;
          -  Chronic kidney disease stage IV-V (eGFR &lt; 30ml/min/1.73m2)&#xD;
&#xD;
          -  History of transplantation&#xD;
&#xD;
          -  History of acute kidney injury before randomization&#xD;
&#xD;
          -  Use of other nephrotoxic agents such as non steroidal anti-inflammatory drugs,&#xD;
             aminoglycosides, colistin, vancomycin&#xD;
&#xD;
          -  Receiving contrast media during last 72 hours&#xD;
&#xD;
          -  Liver disease (bilirubin &gt; 2 mg/dl, transaminase levels &gt;2.5 times the upper limit&#xD;
             normal)&#xD;
&#xD;
          -  Active infection&#xD;
&#xD;
          -  Patients with high risks of dehydration owing to poor oral intake&#xD;
&#xD;
          -  High blood pressure (&gt; 180/110 mmHg despite antihypertensive medications)&#xD;
&#xD;
          -  Hypersensitivity to Gemigliptin or its excipients&#xD;
&#xD;
          -  Low compliance to Gemigliptin treatment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ki Young Na</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Bundang Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ki Young Na</last_name>
    <phone>82 31 787 7030</phone>
  </overall_contact>
  <location>
    <facility>
      <name>Seoul National University Bundang Hospital</name>
      <address>
        <city>Seongnam-si</city>
        <state>Gyeonggi-do</state>
        <zip>463-707</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hyunjin Cho</last_name>
      <phone>82 31 787 7030</phone>
    </contact>
    <investigator>
      <last_name>Ki Young Na, MD PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <link>
    <url>http://druginfo.nlm.nih.gov/drugportal/ProxyServlet?mergeData=true&amp;objectHandle=DBMaint&amp;APPLICATION_NAME=drugportal&amp;actionHandle=default&amp;nextPage=jsp/drugportal/ResultScreen.jsp&amp;TXTSUPERLISTID=0015663271&amp;QV1=CISPLATIN</url>
    <description>cisplatin</description>
  </link>
  <link>
    <url>http://druginfo.nlm.nih.gov/drugportal/ProxyServlet?mergeData=true&amp;objectHandle=DBMaint&amp;APPLICATION_NAME=drugportal&amp;actionHandle=default&amp;nextPage=jsp/drugportal/ResultScreen.jsp&amp;TXTSUPERLISTID=0911637199&amp;QV1=GEMIGLIPTIN</url>
    <description>gemigliptin</description>
  </link>
  <link>
    <url>https://clinicaltrials.gov/ct2/info/fdalinks</url>
    <description>U.S. FDA Resources</description>
  </link>
  <results_reference>
    <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.</citation>
    <PMID>24092928</PMID>
  </results_reference>
  <verification_date>April 2016</verification_date>
  <study_first_submitted>September 24, 2014</study_first_submitted>
  <study_first_submitted_qc>September 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2014</study_first_posted>
  <last_update_submitted>April 18, 2016</last_update_submitted>
  <last_update_submitted_qc>April 18, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 20, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Bundang Hospital</investigator_affiliation>
    <investigator_full_name>Ki Young Na</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Cisplatin</keyword>
  <keyword>Nephrotoxicity</keyword>
  <keyword>Gemigliptin</keyword>
  <keyword>DPP4 inhibitor</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Kidney Injury</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cisplatin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02250872
org study id: B1408264002
nct id: NCT02250872
lead sponsor: 
collaborator: 
has dmc: No
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.
This study will investigate possible renoprotective effects of DPP4 inhibitor on cisplatin
      induced acute kidney injury.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Care Provider)
measure: Incidence of acute kidney injury defined as any of the followings
time frame: up to 7 days
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.
measure: delta Cr
time frame: Time Frame: up to 7 days
description: Change of serum creatinine from baseline to 7 days after cisplatin treatment.
measure: delta eGFR
time frame: up to 7 days
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.
arm group label: Experimental: Gemigliptin and Cisplatin
arm group type: Active Comparator
description: Gemigliptin 100mg daily in two divided doses for 8 days starting from one day before cisplatin-treatment
arm group label: Control arm
arm group type: Placebo Comparator
description: Placebo 100mg daily in two divided doses for 8 days starting from one day before cisplatin-treatment
intervention type: Drug
intervention name: Gemigliptin
description: Gemigliptin 100mg in 2 divided doses plus cisplatin
arm group label: Experimental: Gemigliptin and Cisplatin
other name: Zemiglo
intervention type: Drug
intervention name: Placebo
description: 100mg in 2 divided doses plus cisplatin
arm group label: Control arm
other name: Identical inert tablet to mimic gemigliptin (50mg)
intervention type: Drug
intervention name: Cisplatin
description: All patients will receive intravenous cisplatin
arm group label: Control arm
arm group label: Experimental: Gemigliptin and Cisplatin
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Ki Young Na
role: Principal Investigator
affiliation: Seoul National University Bundang Hospital
last name: Ki Young Na
phone: 82 31 787 7030
facility: 
status: Recruiting
contact: 
investigator: 
country: Korea, Republic of
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
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.
PMID: 24092928
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Bundang Hospital
investigator full name: Ki Young Na
investigator title: Professor
mesh term: Acute Kidney Injury
mesh term: Cisplatin
sharing ipd: Undecided