<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/NCT01690832</url>
  </required_header>
  <id_info>
    <org_study_id>595/2012/D</org_study_id>
    <nct_id>NCT01690832</nct_id>
  </id_info>
  <brief_title>Fenoldopam for Prevention of Acute Kidney Injury</brief_title>
  <acronym>FANCY</acronym>
  <official_title>Fenoldopam for Prevention of Acute kidNey Injury in Patients With aCute coronarY Syndrome Undergoing Coronary Angiography and/or Percutaneous Coronary Intervention - The FANCY Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Roma La Sapienza</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Roma La Sapienza</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients with acute coronary syndromes (ACS) are at increased risk for acute kidney injury&#xD;
      (AKI) when they undergo urgent/emergency coronary angiography.&#xD;
&#xD;
      The optimal medical treatment for preventing the occurrence of contrast induced - acute&#xD;
      kidney injury is still controversial.&#xD;
&#xD;
      Fenoldopam mesylate is a dopamine A1 receptor agonist that augments renal plasma flow that&#xD;
      has reduced the risk of radiocontrast dye nephropathy in some (but not all) preliminary&#xD;
      studies.&#xD;
&#xD;
      Neutrophil gelatinase-associated lipocalin (NGAL) is a new biomarker predictive for AKI&#xD;
      already shown to be useful for earlier diagnosis of contrast induced nephropathy.&#xD;
&#xD;
      The primary objective of this study is to to test the hypothesis that fenoldopam, in addition&#xD;
      to standard treatment, reduce the occurrence of contrast induced - acute kidney injury in&#xD;
      patients with acute coronary syndrome (ACS) undergoing urgent/emergency coronary angiography&#xD;
      and/or percutaneous coronary intervention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with acute coronary syndromes (ACS) are at increased risk for acute kidney injury&#xD;
      (AKI) when they undergo urgent/emergency coronary angiography.&#xD;
&#xD;
      The optimal medical treatment for preventing the occurrence of contrast induced - acute&#xD;
      kidney injury is still controversial.&#xD;
&#xD;
      Fenoldopam mesylate is a dopamine A1 receptor agonist that augments renal plasma flow that&#xD;
      has reduced the risk of radiocontrast dye nephropathy in some (but not all) preliminary&#xD;
      studies.&#xD;
&#xD;
      Neutrophil gelatinase-associated lipocalin (NGAL) is a new biomarker predictive for AKI&#xD;
      already shown to be useful for earlier diagnosis of contrast induced nephropathy.&#xD;
&#xD;
      The primary objective of this study is to to test the hypothesis that fenoldopam, in addition&#xD;
      to standard treatment, reduce the occurrence of contrast induced - acute kidney injury in&#xD;
      patients with acute coronary syndrome (ACS) undergoing urgent/emergency coronary angiography&#xD;
      and/or percutaneous coronary intervention.&#xD;
&#xD;
      Patients will be randomized to standard i.v. 1 ml/kg/h saline infusion (Gr. A, N= 50) or to a&#xD;
      combination of i.v. 1 ml/kg/h saline infusion and fenoldopam administration (0.08 mcg/Kg/min)&#xD;
      from 6 hours before the procedure to 12 hours after the procedure.&#xD;
&#xD;
      Primary End-points&#xD;
&#xD;
      • Incidence of contrast induced acute kidney injury&#xD;
&#xD;
      Secondary End-points&#xD;
&#xD;
      • Post-angiographic 48-h absolute increase in creatinine, absolute increase in estimated&#xD;
      glomerular filtration rate, and Neutrophil gelatinase-associated lipocalin (NGAL) value&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>September 2012</start_date>
  <completion_date type="Anticipated">December 2014</completion_date>
  <primary_completion_date type="Anticipated">December 2013</primary_completion_date>
  <phase>Phase 4</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Contrast induced acute kidney injury</measure>
    <time_frame>48 hour</time_frame>
    <description>Incidence of contrast induced acute kidney injury at 48 hour post-procedural control</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Markers of kidney injury</measure>
    <time_frame>48 hour</time_frame>
    <description>Post-angiographic 48-h absolute increase in creatinine, absolute increase in estimated glomerular filtration rate, and Neutrophil gelatinase-associated lipocalin (NGAL) value</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>standard saline infusion</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>standard i.v. 1 ml/kg/h saline infusion from 6 hours before the procedure to 12 hours after the procedure.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>fenoldopam infusion</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>combination of i.v. 1 ml/kg/h saline infusion and fenoldopam administration (0.08 mcg/Kg/min) from 6 hours before the procedure to 12 hours after the procedure.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>standard saline infusion</intervention_name>
    <description>i.v. 1 ml/kg/h saline infusion from 6 hours before the procedure to 12 hours after the procedure</description>
    <arm_group_label>fenoldopam infusion</arm_group_label>
    <arm_group_label>standard saline infusion</arm_group_label>
    <other_name>saline infusion</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>fenoldopam infusion</intervention_name>
    <description>combination of i.v. 1 ml/kg/h saline infusion and fenoldopam administration (0.08 mcg/Kg/min) from 6 hours before the procedure to 12 hours after the procedure</description>
    <arm_group_label>fenoldopam infusion</arm_group_label>
    <other_name>fenoldopam administration (0.08 mcg/Kg/min)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Indication to urgent/emergency coronary angiography&#xD;
&#xD;
          -  Normal renal function (eGFR&gt; 60 ml/min/1.73 m2)&#xD;
&#xD;
          -  Moderate or high Mehran's risk score for CIN (&gt;11).&#xD;
&#xD;
          -  Able to understand and willing to sign the informed CF&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        • Women of child bearing potential patients must demonstrate a negative pregnancy test&#xD;
        performed within 24 hours before CT&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Francesco Pelliccia, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sapienza University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sapienza University</name>
      <address>
        <city>Rome</city>
        <state>Lazio</state>
        <zip>00166</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 19, 2012</study_first_submitted>
  <study_first_submitted_qc>September 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 24, 2012</study_first_posted>
  <last_update_submitted>September 19, 2012</last_update_submitted>
  <last_update_submitted_qc>September 19, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 24, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Roma La Sapienza</investigator_affiliation>
    <investigator_full_name>Francesco Pelliccia</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Contrast induced acute kidney injury</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Kidney Injury</mesh_term>
    <mesh_term>Coronary Artery Disease</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fenoldopam</mesh_term>
  </intervention_browse>
  <!-- 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/NCT01690832
org study id: 595/2012/D
nct id: NCT01690832
lead sponsor: 
has dmc: Yes
Patients with acute coronary syndromes (ACS) are at increased risk for acute kidney injury
      (AKI) when they undergo urgent/emergency coronary angiography.

      The optimal medical treatment for preventing the occurrence of contrast induced - acute
      kidney injury is still controversial.

      Fenoldopam mesylate is a dopamine A1 receptor agonist that augments renal plasma flow that
      has reduced the risk of radiocontrast dye nephropathy in some (but not all) preliminary
      studies.

      Neutrophil gelatinase-associated lipocalin (NGAL) is a new biomarker predictive for AKI
      already shown to be useful for earlier diagnosis of contrast induced nephropathy.

      The primary objective of this study is to to test the hypothesis that fenoldopam, in addition
      to standard treatment, reduce the occurrence of contrast induced - acute kidney injury in
      patients with acute coronary syndrome (ACS) undergoing urgent/emergency coronary angiography
      and/or percutaneous coronary intervention.
Patients with acute coronary syndromes (ACS) are at increased risk for acute kidney injury
      (AKI) when they undergo urgent/emergency coronary angiography.

      The optimal medical treatment for preventing the occurrence of contrast induced - acute
      kidney injury is still controversial.

      Fenoldopam mesylate is a dopamine A1 receptor agonist that augments renal plasma flow that
      has reduced the risk of radiocontrast dye nephropathy in some (but not all) preliminary
      studies.

      Neutrophil gelatinase-associated lipocalin (NGAL) is a new biomarker predictive for AKI
      already shown to be useful for earlier diagnosis of contrast induced nephropathy.

      The primary objective of this study is to to test the hypothesis that fenoldopam, in addition
      to standard treatment, reduce the occurrence of contrast induced - acute kidney injury in
      patients with acute coronary syndrome (ACS) undergoing urgent/emergency coronary angiography
      and/or percutaneous coronary intervention.

      Patients will be randomized to standard i.v. 1 ml/kg/h saline infusion (Gr. A, N= 50) or to a
      combination of i.v. 1 ml/kg/h saline infusion and fenoldopam administration (0.08 mcg/Kg/min)
      from 6 hours before the procedure to 12 hours after the procedure.

      Primary End-points

      • Incidence of contrast induced acute kidney injury

      Secondary End-points

      • Post-angiographic 48-h absolute increase in creatinine, absolute increase in estimated
      glomerular filtration rate, and Neutrophil gelatinase-associated lipocalin (NGAL) value
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Contrast induced acute kidney injury
time frame: 48 hour
description: Incidence of contrast induced acute kidney injury at 48 hour post-procedural control
measure: Markers of kidney injury
time frame: 48 hour
description: Post-angiographic 48-h absolute increase in creatinine, absolute increase in estimated glomerular filtration rate, and Neutrophil gelatinase-associated lipocalin (NGAL) value
arm group label: standard saline infusion
arm group type: Active Comparator
description: standard i.v. 1 ml/kg/h saline infusion from 6 hours before the procedure to 12 hours after the procedure.
arm group label: fenoldopam infusion
arm group type: Active Comparator
description: combination of i.v. 1 ml/kg/h saline infusion and fenoldopam administration (0.08 mcg/Kg/min) from 6 hours before the procedure to 12 hours after the procedure.
intervention type: Drug
intervention name: standard saline infusion
description: i.v. 1 ml/kg/h saline infusion from 6 hours before the procedure to 12 hours after the procedure
arm group label: fenoldopam infusion
arm group label: standard saline infusion
other name: saline infusion
intervention type: Drug
intervention name: fenoldopam infusion
description: combination of i.v. 1 ml/kg/h saline infusion and fenoldopam administration (0.08 mcg/Kg/min) from 6 hours before the procedure to 12 hours after the procedure
arm group label: fenoldopam infusion
other name: fenoldopam administration (0.08 mcg/Kg/min)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Francesco Pelliccia, MD
role: Principal Investigator
affiliation: Sapienza University
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: University of Roma La Sapienza
investigator full name: Francesco Pelliccia
investigator title: Assistant Professor
mesh term: Acute Kidney Injury
mesh term: Coronary Artery Disease
mesh term: Fenoldopam