<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/NCT01722513</url>
  </required_header>
  <id_info>
    <org_study_id>NCT20120312</org_study_id>
    <nct_id>NCT01722513</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Alprostadil Prevent Contrast Induced Nephropathy</brief_title>
  <official_title>Phase 4 Study of Alprostadil Prevent Contrast Induced Nephropathy in Patients Receiving a Cardiac Catheterization</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai 10th People's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai 10th People's Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this prospective, randomized, controlled study is to investigate the effect of&#xD;
      pretreatment with intravenous Alprostadil on the incidence of CIN in a high-risk population&#xD;
      of patients with both type 2 diabetes mellitus (T2DM) and CKD undergoing coronary&#xD;
      angiography, and evaluate the influence of such potential benefit on short-term outcome.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The number of cardiac angiography and percutaneous coronary interventions (PCI) has increased&#xD;
      steadily in recent years. This has resulted in the increasing incidence of contrast-induced&#xD;
      nephropathy (CIN). Major risk factors for CIN include older age, diabetes mellitus (DM),&#xD;
      chronic kidney disease (CKD).&#xD;
&#xD;
      The aim of this prospective, randomized, controlled study is to investigate the effect of&#xD;
      pretreatment with intravenous Alprostadil on the incidence of CIN in a high-risk population&#xD;
      of patients with both type 2 diabetes mellitus (T2DM) and CKD undergoing coronary&#xD;
      angiography, and evaluate the influence of such potential benefit on short-term outcome.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>November 2012</start_date>
  <completion_date type="Anticipated">February 2014</completion_date>
  <primary_completion_date type="Anticipated">November 2013</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Primary Outcome</measure>
    <time_frame>72 h</time_frame>
    <description>An absolute increase in SCr &gt;=0.5mg/dL（&gt;=44.2μmmol/L）or a &gt;= 25% increase in SCr from baseline to 72h after the procedure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Secondary Outcome</measure>
    <time_frame>30 d</time_frame>
    <description>The composite of hospitalization for aggravated renal function, acute renal failure, dialysis or hemofiltration, aggravated at least 1 class of heart function, acute left ventricular failure or death from all causes.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Kidney Diseases</condition>
  <condition>Diabetes Mellitus</condition>
  <condition>Acute Kidney Injury</condition>
  <condition>Kidney Failure, Chronic</condition>
  <condition>Renal Insufficiency</condition>
  <arm_group>
    <arm_group_label>Alprostadil, Control</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Alprostadil interventions: Alprostadil 40 ug + 1cc/kg/hr normal salin 6 hour before and after angiography AND Control interventions:Normal salin 1cc/kg/hr before and after angiography</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Alprostadil ﹠control</intervention_name>
    <description>control:Normal salin 1cc/kg/hr before and after angiography</description>
    <arm_group_label>Alprostadil, Control</arm_group_label>
    <other_name>Drug: Alprostadil</other_name>
    <other_name>lipo-alprostadil</other_name>
    <other_name>Prostaglandin E1</other_name>
    <other_name>Drug: normal salin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient that underwent coronary angiography&#xD;
&#xD;
          -  T2DM&#xD;
&#xD;
          -  CKD stages 2 and 3, eGFR 30 to 89ml/min per 1.73m2&#xD;
&#xD;
          -  Alprostadil naive, or not on Alprostadil treatment for at least 14 days&#xD;
&#xD;
          -  Withdrawal metformin or aminophylline for 48h before angiography&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  serum Cr. More than 3 mg/dl&#xD;
&#xD;
          -  electrolyte and acid-base imbalance&#xD;
&#xD;
          -  pulmonary edema&#xD;
&#xD;
          -  allergy to Alprostadil&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ya-Wei Xu, MD, FACC</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Cardiology, Shanghai Tenth People's Hospital, Tongji University School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Cardiology, Shanghai Tenth People's Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200072</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <results_reference>
    <citation>Koch JA, Plum J, Grabensee B, Modder U. Prostaglandin E1: a new agent for the prevention of renal dysfunction in high risk patients caused by radiocontrast media? PGE1 Study Group. Nephrol Dial Transplant. 2000 Jan;15(1):43-9. doi: 10.1093/ndt/15.1.43.</citation>
    <PMID>10607766</PMID>
  </results_reference>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 3, 2012</study_first_submitted>
  <study_first_submitted_qc>November 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 7, 2012</study_first_posted>
  <last_update_submitted>November 6, 2012</last_update_submitted>
  <last_update_submitted_qc>November 6, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 7, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shanghai 10th People's Hospital</investigator_affiliation>
    <investigator_full_name>Ya-Wei Xu</investigator_full_name>
    <investigator_title>MD FACC</investigator_title>
  </responsible_party>
  <keyword>Contrast Induced Nephropathy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Acute Kidney Injury</mesh_term>
    <mesh_term>Renal Insufficiency</mesh_term>
    <mesh_term>Kidney Failure, Chronic</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alprostadil</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/NCT01722513
org study id: NCT20120312
nct id: NCT01722513
lead sponsor: 
has dmc: Yes
The aim of this prospective, randomized, controlled study is to investigate the effect of
      pretreatment with intravenous Alprostadil on the incidence of CIN in a high-risk population
      of patients with both type 2 diabetes mellitus (T2DM) and CKD undergoing coronary
      angiography, and evaluate the influence of such potential benefit on short-term outcome.
The number of cardiac angiography and percutaneous coronary interventions (PCI) has increased
      steadily in recent years. This has resulted in the increasing incidence of contrast-induced
      nephropathy (CIN). Major risk factors for CIN include older age, diabetes mellitus (DM),
      chronic kidney disease (CKD).

      The aim of this prospective, randomized, controlled study is to investigate the effect of
      pretreatment with intravenous Alprostadil on the incidence of CIN in a high-risk population
      of patients with both type 2 diabetes mellitus (T2DM) and CKD undergoing coronary
      angiography, and evaluate the influence of such potential benefit on short-term outcome.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: Primary Outcome
time frame: 72 h
description: An absolute increase in SCr >=0.5mg/dL（>=44.2μmmol/L）or a >= 25% increase in SCr from baseline to 72h after the procedure
measure: Secondary Outcome
time frame: 30 d
description: The composite of hospitalization for aggravated renal function, acute renal failure, dialysis or hemofiltration, aggravated at least 1 class of heart function, acute left ventricular failure or death from all causes.
arm group label: Alprostadil, Control
arm group type: Experimental
description: Alprostadil interventions: Alprostadil 40 ug + 1cc/kg/hr normal salin 6 hour before and after angiography AND Control interventions:Normal salin 1cc/kg/hr before and after angiography
intervention type: Drug
intervention name: Alprostadil ﹠control
description: control:Normal salin 1cc/kg/hr before and after angiography
arm group label: Alprostadil, Control
other name: Drug: Alprostadil
other name: lipo-alprostadil
other name: Prostaglandin E1
other name: Drug: normal salin
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ya-Wei Xu, MD, FACC
role: Principal Investigator
affiliation: Department of Cardiology, Shanghai Tenth People's Hospital, Tongji University School of Medicine
facility: 
country: China
citation: Koch JA, Plum J, Grabensee B, Modder U. Prostaglandin E1: a new agent for the prevention of renal dysfunction in high risk patients caused by radiocontrast media? PGE1 Study Group. Nephrol Dial Transplant. 2000 Jan;15(1):43-9. doi: 10.1093/ndt/15.1.43.
PMID: 10607766
responsible party type: Principal Investigator
investigator affiliation: Shanghai 10th People's Hospital
investigator full name: Ya-Wei Xu
investigator title: MD FACC
mesh term: Kidney Diseases
mesh term: Acute Kidney Injury
mesh term: Renal Insufficiency
mesh term: Kidney Failure, Chronic
mesh term: Alprostadil