<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/NCT03767322</url>
  </required_header>
  <id_info>
    <org_study_id>PT-18-081</org_study_id>
    <nct_id>NCT03767322</nct_id>
  </id_info>
  <brief_title>Effect of Allopurinol or Febuxostat to Prevent Contrast Induced Acute Kidney Injury (CI-AKI)</brief_title>
  <acronym>CI-AKI</acronym>
  <official_title>Effect of Allopurinol or Febuxostat to Prevent Contrast Induced Acute Kidney Injury (CI-AKI)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Instituto Nacional de Cardiologia Ignacio Chavez</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Salvador López Gil</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Armando Vázquez Rangel</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Instituto Nacional de Cardiologia Ignacio Chavez</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      A randomized, placebo-controlled, double-blind clinical trial of effect of allopurinol or&#xD;
      febuxostat to prevent contrast induced acute kidney injury (CI-AKI)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Eligible patients (patients with glomerular filtration rate &lt; 60 ml/min or high riks patients&#xD;
      based on Mehran score) that will be undergoing cardiac catheterization/intervention randomly&#xD;
      assigned to receive allopurinol 300 mg or febuxostat 80 mg 12 hours before and 12 after 1&#xD;
      exposure of radiocontrast and IV hydration (normal saline 1 ml/kg/hr 12 pre and post&#xD;
      radiocontrast exposure) or placebo and hydration.&#xD;
&#xD;
      Exclusion criteria: patients under treatment with allopurinol or febuxostat in the previous&#xD;
      seven days, known allergy to allopurinol or febuxostat, patients on renal replacement therapy&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">December 5, 2018</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">October 2019</primary_completion_date>
  <phase>Phase 2</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>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>Double blind clinical trial</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Prevention of contrast induced acute kidney injury</measure>
    <time_frame>48 hours</time_frame>
    <description>Increase in serum creatinine by ≥ 0.3 mg/dl within 48 hours</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Renal replacement therapy requirement</measure>
    <time_frame>7 days</time_frame>
    <description>Initiation of renal replacement therapy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of hospitalization</measure>
    <time_frame>3 days to 90 days</time_frame>
    <description>Length of hospitalization</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">558</enrollment>
  <condition>Contrast-induced Nephropathy</condition>
  <condition>Contrast-induced Acute Kidney Injury</condition>
  <arm_group>
    <arm_group_label>Allopurinol group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The intervention group will receive 300 mg of allopurinol 12 hours before and 12 hours after the coronary intervention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The placebo group will receive 300 mg of placebo 12 hours before and 12 hours after the coronary intervention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Febuxostat group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The intervention group will receive 80 mg of febuxostat 12 hours before and 12 hours after the coronary intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Allopurinol</intervention_name>
    <description>Eligible patients will receive allopurinol 300 mg before and after coronary intervention</description>
    <arm_group_label>Allopurinol group</arm_group_label>
    <other_name>Zyloprim</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Febuxostat</intervention_name>
    <description>Eligible patients will receive febuxostat 80 mg before and after coronary intervention</description>
    <arm_group_label>Febuxostat group</arm_group_label>
    <other_name>Turazive</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Eligible patients will receive before and after coronary intervention</description>
    <arm_group_label>Placebo group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 years and older who are scheduled to coronary intervention&#xD;
&#xD;
          -  Patients with Mehran score &gt; 5 or modified Mehran score &gt;2 even glomerular filtration&#xD;
             rate &gt; 60 ml/min (high risk patients)&#xD;
&#xD;
          -  Glomerular Filtration Rate &lt; 60 ml/min&#xD;
&#xD;
          -  All the patients provided written informed consent for the procedures and the test&#xD;
             drug&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with shorter hospital stay (&lt;48 hours)&#xD;
&#xD;
          -  Patients under treatment with allopurinol of febuxostat&#xD;
&#xD;
          -  Patients on renal replacement therapy&#xD;
&#xD;
          -  Known allergy to allopurinol or febuxostat&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Magdalena Madero, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Instituto Nacional de Cardiologia Ignacio Chavez</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Magdalena Madero, MD</last_name>
    <phone>01 52 55 5573 2911</phone>
    <phone_ext>21425</phone_ext>
    <email>madero.magdalena@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Salvador Lopez-Gil, MD</last_name>
    <phone>01 52 55 5573 2911</phone>
    <phone_ext>21425</phone_ext>
    <email>salvadorlgil@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Instituto Nacional de Cardiologia Ignacio Chavez</name>
      <address>
        <city>Mexico City</city>
        <state>México City</state>
        <country>Mexico</country>
      </address>
    </facility>
    <contact>
      <last_name>Magdalena Madero, MD</last_name>
      <phone>015255 5573 2911</phone>
      <phone_ext>21425</phone_ext>
      <email>madero.magdalena@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Salvador Lopez-Gil, MD</last_name>
      <phone>015255 5573 2911</phone>
      <phone_ext>21425</phone_ext>
      <email>salvadorlgil@gmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Mexico</country>
  </location_countries>
  <reference>
    <citation>Ghelich Khan Z, Talasaz AH, Pourhosseini H, Hosseini K, Alemzadeh Ansari MJ, Jalali A. Potential Role of Allopurinol in Preventing Contrast-Induced Nephropathy in Patients Undergoing Percutaneous Coronary Intervention: A Randomized Placebo-Controlled Trial. Clin Drug Investig. 2017 Sep;37(9):853-860. doi: 10.1007/s40261-017-0542-z.</citation>
    <PMID>28608311</PMID>
  </reference>
  <reference>
    <citation>Kumar A, Bhawani G, Kumari N, Murthy KS, Lalwani V, Raju ChN. Comparative study of renal protective effects of allopurinol and N-acetyl-cysteine on contrast induced nephropathy in patients undergoing cardiac catheterization. J Clin Diagn Res. 2014 Dec;8(12):HC03-7. doi: 10.7860/JCDR/2014/9638.5255. Epub 2014 Dec 5.</citation>
    <PMID>25653965</PMID>
  </reference>
  <reference>
    <citation>Mendi MA, Afsar B, Oksuz F, Turak O, Yayla C, Ozcan F, Johnson RJ, Kanbay M. Uric Acid is a Useful Tool to Predict Contrast-Induced Nephropathy. Angiology. 2017 Aug;68(7):627-632. doi: 10.1177/0003319716639187. Epub 2016 Mar 22.</citation>
    <PMID>27006404</PMID>
  </reference>
  <reference>
    <citation>Shibagaki Y, Ohno I, Hosoya T, Kimura K. Safety, efficacy and renal effect of febuxostat in patients with moderate-to-severe kidney dysfunction. Hypertens Res. 2014 Oct;37(10):919-25. doi: 10.1038/hr.2014.107. Epub 2014 Jun 19.</citation>
    <PMID>24942770</PMID>
  </reference>
  <reference>
    <citation>Fukui T, Maruyama M, Yamauchi K, Yoshitaka S, Yasuda T, Abe Y. Effects of Febuxostat on Oxidative Stress. Clin Ther. 2015 Jul 1;37(7):1396-401. doi: 10.1016/j.clinthera.2015.03.026. Epub 2015 Apr 23.</citation>
    <PMID>25913922</PMID>
  </reference>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>October 14, 2018</study_first_submitted>
  <study_first_submitted_qc>December 5, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 6, 2018</study_first_posted>
  <last_update_submitted>December 5, 2018</last_update_submitted>
  <last_update_submitted_qc>December 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 6, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Instituto Nacional de Cardiologia Ignacio Chavez</investigator_affiliation>
    <investigator_full_name>Magdalena Madero</investigator_full_name>
    <investigator_title>Nephrology Department</investigator_title>
  </responsible_party>
  <keyword>contrast induced acute kidney injury</keyword>
  <keyword>contrast induced nephropathy</keyword>
  <keyword>allopurinol</keyword>
  <keyword>febuxostat</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Kidney Injury</mesh_term>
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Allopurinol</mesh_term>
    <mesh_term>Febuxostat</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/NCT03767322
org study id: PT-18-081
nct id: NCT03767322
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
A randomized, placebo-controlled, double-blind clinical trial of effect of allopurinol or
      febuxostat to prevent contrast induced acute kidney injury (CI-AKI)
Eligible patients (patients with glomerular filtration rate < 60 ml/min or high riks patients
      based on Mehran score) that will be undergoing cardiac catheterization/intervention randomly
      assigned to receive allopurinol 300 mg or febuxostat 80 mg 12 hours before and 12 after 1
      exposure of radiocontrast and IV hydration (normal saline 1 ml/kg/hr 12 pre and post
      radiocontrast exposure) or placebo and hydration.

      Exclusion criteria: patients under treatment with allopurinol or febuxostat in the previous
      seven days, known allergy to allopurinol or febuxostat, patients on renal replacement therapy
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
masking description: Double blind clinical trial
measure: Prevention of contrast induced acute kidney injury
time frame: 48 hours
description: Increase in serum creatinine by ≥ 0.3 mg/dl within 48 hours
measure: Renal replacement therapy requirement
time frame: 7 days
description: Initiation of renal replacement therapy
measure: Length of hospitalization
time frame: 3 days to 90 days
description: Length of hospitalization
arm group label: Allopurinol group
arm group type: Active Comparator
description: The intervention group will receive 300 mg of allopurinol 12 hours before and 12 hours after the coronary intervention.
arm group label: Placebo group
arm group type: Placebo Comparator
description: The placebo group will receive 300 mg of placebo 12 hours before and 12 hours after the coronary intervention.
arm group label: Febuxostat group
arm group type: Active Comparator
description: The intervention group will receive 80 mg of febuxostat 12 hours before and 12 hours after the coronary intervention
intervention type: Drug
intervention name: Allopurinol
description: Eligible patients will receive allopurinol 300 mg before and after coronary intervention
arm group label: Allopurinol group
other name: Zyloprim
intervention type: Drug
intervention name: Febuxostat
description: Eligible patients will receive febuxostat 80 mg before and after coronary intervention
arm group label: Febuxostat group
other name: Turazive
intervention type: Drug
intervention name: Placebo
description: Eligible patients will receive before and after coronary intervention
arm group label: Placebo group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Magdalena Madero, MD
role: Principal Investigator
affiliation: Instituto Nacional de Cardiologia Ignacio Chavez
last name: Magdalena Madero, MD
phone: 01 52 55 5573 2911
phone ext: 21425
email: madero.magdalena@gmail.com
last name: Salvador Lopez-Gil, MD
phone: 01 52 55 5573 2911
phone ext: 21425
email: salvadorlgil@gmail.com
facility: 
contact: 
contact backup: 
country: Mexico
citation: Ghelich Khan Z, Talasaz AH, Pourhosseini H, Hosseini K, Alemzadeh Ansari MJ, Jalali A. Potential Role of Allopurinol in Preventing Contrast-Induced Nephropathy in Patients Undergoing Percutaneous Coronary Intervention: A Randomized Placebo-Controlled Trial. Clin Drug Investig. 2017 Sep;37(9):853-860. doi: 10.1007/s40261-017-0542-z.
PMID: 28608311
citation: Kumar A, Bhawani G, Kumari N, Murthy KS, Lalwani V, Raju ChN. Comparative study of renal protective effects of allopurinol and N-acetyl-cysteine on contrast induced nephropathy in patients undergoing cardiac catheterization. J Clin Diagn Res. 2014 Dec;8(12):HC03-7. doi: 10.7860/JCDR/2014/9638.5255. Epub 2014 Dec 5.
PMID: 25653965
citation: Mendi MA, Afsar B, Oksuz F, Turak O, Yayla C, Ozcan F, Johnson RJ, Kanbay M. Uric Acid is a Useful Tool to Predict Contrast-Induced Nephropathy. Angiology. 2017 Aug;68(7):627-632. doi: 10.1177/0003319716639187. Epub 2016 Mar 22.
PMID: 27006404
citation: Shibagaki Y, Ohno I, Hosoya T, Kimura K. Safety, efficacy and renal effect of febuxostat in patients with moderate-to-severe kidney dysfunction. Hypertens Res. 2014 Oct;37(10):919-25. doi: 10.1038/hr.2014.107. Epub 2014 Jun 19.
PMID: 24942770
citation: Fukui T, Maruyama M, Yamauchi K, Yoshitaka S, Yasuda T, Abe Y. Effects of Febuxostat on Oxidative Stress. Clin Ther. 2015 Jul 1;37(7):1396-401. doi: 10.1016/j.clinthera.2015.03.026. Epub 2015 Apr 23.
PMID: 25913922
responsible party type: Principal Investigator
investigator affiliation: Instituto Nacional de Cardiologia Ignacio Chavez
investigator full name: Magdalena Madero
investigator title: Nephrology Department
mesh term: Acute Kidney Injury
mesh term: Kidney Diseases
mesh term: Wounds and Injuries
mesh term: Allopurinol
mesh term: Febuxostat
sharing ipd: Undecided