<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/NCT01660295</url>
  </required_header>
  <id_info>
    <org_study_id>CMEX839BDE07</org_study_id>
    <secondary_id>2011-001930-40</secondary_id>
    <nct_id>NCT01660295</nct_id>
  </id_info>
  <brief_title>Pharmacokinetics of Certoparin in Subjects With Renal Insufficiency and Healthy Subjects</brief_title>
  <official_title>An Open-label, Single Center, Parallel-group Study to Compare the Single- and Repeated-dose Pharmacokinetics of Stepwise Increasing Doses of Subcutaneous Certoparin (3000 IU o.d., 3000 IU b.i.d., 8000 IU o.d., and 8000 IU b.i.d.) in Subjects With Severe Renal Insufficiency and Healthy Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Novartis Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Novartis</source>
  <brief_summary>
    <textblock>
      This study will assess the pharmacokinetics in subjects with severe renal insufficiency and&#xD;
      healthy subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2011</start_date>
  <primary_completion_date type="Actual">June 2012</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Plasma aXa-Profile: C0</measure>
    <time_frame>5 days</time_frame>
    <description>Estimate of the effects of renal insufficiency on the systemic exposure to aXa for once daily (τ = 24 h) repeated doses of 3,000 IU aXa as characterized by pre-dose trough (C0,ss) aXa comparing REN-patients with matched CON-subjects studied in parallel.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Dose regimen, systemic total exposure to aXa (AUC0-τ,ss)</measure>
    <time_frame>5 days</time_frame>
    <description>Dosage regimen (3,000 o.d., 3,000 b.i.d., 8,000 o.d., 8,000 IU aXa in the morning plus 3,000 IU aXa in the evening, or 8,000 b.i.d. IU aXa) that yields a systemic total exposure to aXa (AUC0-τ,ss) in REN-patients similar to that achieved with 8,000 b.i.d. IU aXa in CON-subjects.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma aXa-Profile: Cmax</measure>
    <time_frame>5 days</time_frame>
    <description>Estimate of the effects of renal insufficiency on the systemic exposure to aXa for once daily (τ = 24 h) repeated doses of 3,000 IU aXa as characterized by maximum (Cmax,ss), aXa comparing REN-patients with matched CON-subjects studied in parallel.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma aXa-Profile: AUC</measure>
    <time_frame>5 days</time_frame>
    <description>Estimate of the effects of renal insufficiency on the systemic exposure to aXa for once daily (τ = 24 h) repeated doses of 3,000 IU aXa as characterized by total (AUC0-τ,ss) aXa comparing REN-patients with matched CON-subjects studied in parallel.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Renal Insufficiency</condition>
  <arm_group>
    <arm_group_label>Certoparin control</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants receive Certoparin 3,000 IU during period 1. Participants will receive 8,000 IU during period 2, if qualified as per medical criteria.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Certoparin Renal</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants receive dose escalation upon medical criteria qualification at each period:&#xD;
Certoparin 3,000 IU once a day during period 1. Certoparin 3,000 IU twice a day during period 2. Certoparin 8,000 IU once a day during period 3. Certoparin 8,000 IU in the morning and 3,000 IU in the evening during period 4 OR Certoparin 8,000 IU twice a day during period 4.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Certoparin 3,000 IU Once Daily</intervention_name>
    <description>Certoparin 3,000 IU subcutaneous injection once daily</description>
    <arm_group_label>Certoparin Renal</arm_group_label>
    <arm_group_label>Certoparin control</arm_group_label>
    <other_name>Mono-Embolex</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Certoparin 3,000 IU Twice a Day</intervention_name>
    <description>Certoparin 3,000 IU subcutaneous injection twice a day</description>
    <arm_group_label>Certoparin Renal</arm_group_label>
    <other_name>Mono-Embolex</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Certoparin 8,000 IU Once Daily</intervention_name>
    <description>Certoparin 8,000 IU subcutaneous injection once daily</description>
    <arm_group_label>Certoparin Renal</arm_group_label>
    <other_name>Mono-Embolex</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Certoparin 8,000 IU Twice a Day</intervention_name>
    <description>Certoparin 8,000 IU subcutaneous injection twice a day</description>
    <arm_group_label>Certoparin Renal</arm_group_label>
    <arm_group_label>Certoparin control</arm_group_label>
    <other_name>Mono-Embolex</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Healthy subjects OR&#xD;
&#xD;
          -  Subjects with severe renal insufficiency&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Hypersensitivity to study medication&#xD;
&#xD;
          -  Genetic abnormality or disease of clotting system&#xD;
&#xD;
          -  Prior major surgery or bleeding&#xD;
&#xD;
          -  Other protocol-defined inclusion/exclusion criteria may apply&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>DRC Drug Research Center Ltd., H-8230 Balatonfüred</name>
      <address>
        <city>H-8230 Balatonfüred</city>
        <state>Ady E. u.</state>
        <zip>12</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hungary</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>December 20, 2011</study_first_submitted>
  <study_first_submitted_qc>August 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 8, 2012</study_first_posted>
  <last_update_submitted>August 5, 2012</last_update_submitted>
  <last_update_submitted_qc>August 5, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 8, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Severe renal insufficiency certoparin</keyword>
  <keyword>Severe renal insufficiency</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Renal Insufficiency</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heparin, Low-Molecular-Weight</mesh_term>
    <mesh_term>Dihydroergotamine</mesh_term>
    <mesh_term>Certoparin</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/NCT01660295
org study id: CMEX839BDE07
secondary id: 2011-001930-40
nct id: NCT01660295
lead sponsor: 
This study will assess the pharmacokinetics in subjects with severe renal insufficiency and
      healthy subjects.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Plasma aXa-Profile: C0
time frame: 5 days
description: Estimate of the effects of renal insufficiency on the systemic exposure to aXa for once daily (τ = 24 h) repeated doses of 3,000 IU aXa as characterized by pre-dose trough (C0,ss) aXa comparing REN-patients with matched CON-subjects studied in parallel.
measure: Dose regimen, systemic total exposure to aXa (AUC0-τ,ss)
time frame: 5 days
description: Dosage regimen (3,000 o.d., 3,000 b.i.d., 8,000 o.d., 8,000 IU aXa in the morning plus 3,000 IU aXa in the evening, or 8,000 b.i.d. IU aXa) that yields a systemic total exposure to aXa (AUC0-τ,ss) in REN-patients similar to that achieved with 8,000 b.i.d. IU aXa in CON-subjects.
measure: Plasma aXa-Profile: Cmax
time frame: 5 days
description: Estimate of the effects of renal insufficiency on the systemic exposure to aXa for once daily (τ = 24 h) repeated doses of 3,000 IU aXa as characterized by maximum (Cmax,ss), aXa comparing REN-patients with matched CON-subjects studied in parallel.
measure: Plasma aXa-Profile: AUC
time frame: 5 days
description: Estimate of the effects of renal insufficiency on the systemic exposure to aXa for once daily (τ = 24 h) repeated doses of 3,000 IU aXa as characterized by total (AUC0-τ,ss) aXa comparing REN-patients with matched CON-subjects studied in parallel.
arm group label: Certoparin control
arm group type: Experimental
description: Participants receive Certoparin 3,000 IU during period 1. Participants will receive 8,000 IU during period 2, if qualified as per medical criteria.
arm group label: Certoparin Renal
arm group type: Experimental
description: Participants receive dose escalation upon medical criteria qualification at each period:
Certoparin 3,000 IU once a day during period 1. Certoparin 3,000 IU twice a day during period 2. Certoparin 8,000 IU once a day during period 3. Certoparin 8,000 IU in the morning and 3,000 IU in the evening during period 4 OR Certoparin 8,000 IU twice a day during period 4.
intervention type: Drug
intervention name: Certoparin 3,000 IU Once Daily
description: Certoparin 3,000 IU subcutaneous injection once daily
arm group label: Certoparin Renal
arm group label: Certoparin control
other name: Mono-Embolex
intervention type: Drug
intervention name: Certoparin 3,000 IU Twice a Day
description: Certoparin 3,000 IU subcutaneous injection twice a day
arm group label: Certoparin Renal
other name: Mono-Embolex
intervention type: Drug
intervention name: Certoparin 8,000 IU Once Daily
description: Certoparin 8,000 IU subcutaneous injection once daily
arm group label: Certoparin Renal
other name: Mono-Embolex
intervention type: Drug
intervention name: Certoparin 8,000 IU Twice a Day
description: Certoparin 8,000 IU subcutaneous injection twice a day
arm group label: Certoparin Renal
arm group label: Certoparin control
other name: Mono-Embolex
criteria: 
gender: All
minimum age: 21 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Hungary
responsible party type: Sponsor
mesh term: Renal Insufficiency
mesh term: Heparin, Low-Molecular-Weight
mesh term: Dihydroergotamine
mesh term: Certoparin