<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/NCT01720030</url>
  </required_header>
  <id_info>
    <org_study_id>Levosimendan in AKI Study</org_study_id>
    <nct_id>NCT01720030</nct_id>
  </id_info>
  <brief_title>Levosimendan in Acute Kidney Injury Study</brief_title>
  <acronym>LAKIS</acronym>
  <official_title>Prospective, Randomized, Monocenter, Double Blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Levosimendan in Intensive Care Patients With Acute Kidney Injury</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VieCuri Medical Centre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Orion Corporation, Orion Pharma</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>VieCuri Medical Centre</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      We hypothesise that levosimendan will have a positive influence on renal function during&#xD;
      acute kidney injury in adult intensive care patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this trial is to evaluate whether the use of levosimendan is able to improve&#xD;
      renal function.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>September 2016</start_date>
  <completion_date type="Anticipated">October 2017</completion_date>
  <primary_completion_date type="Anticipated">October 2017</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in renal function</measure>
    <time_frame>Baseline and every 24 hours until end ICU stay</time_frame>
    <description>Daily analysis of kidney function expressed in endogenous creatinine clearance</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">68</enrollment>
  <condition>Acute Kidney Injury</condition>
  <arm_group>
    <arm_group_label>Conventional therapy</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Standard of care as protocolized locally</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Levosimendan</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The experimental group receives standard treatment supplemented by levosimendan (0.2 µg/kg/min) for 24 hours within 36 hrs following onset of AKI.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Levosimendan</intervention_name>
    <description>Verum therapy</description>
    <arm_group_label>Levosimendan</arm_group_label>
    <other_name>Simdax (R)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Conventional therapy</intervention_name>
    <description>Placebo therapy to safeguard blinding</description>
    <arm_group_label>Conventional therapy</arm_group_label>
    <other_name>Standard care plus placebo comparator</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinically diagnosed adult patients with AKI&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Failure to obtain written consent to participate from patient or legal representative&#xD;
             (by deferred consent)&#xD;
&#xD;
          -  Patients entering the ICU for post-operative observation with an estimated length of&#xD;
             stay less than 24 hrs.&#xD;
&#xD;
          -  Moribund patients&#xD;
&#xD;
          -  Patients under the age of 18&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Patients suffering from pre-existing renal failure (elevated NGAL values without&#xD;
             apparent rise in creatinine values)&#xD;
&#xD;
          -  Renal replacement therapy initiated before admission due to Chronic Kidney Disease&#xD;
&#xD;
          -  Hypersensitivity to levosimendan experienced by previous treatments&#xD;
&#xD;
          -  Severe hypotension and tachycardia&#xD;
&#xD;
          -  Significant mechanical obstruction affecting ventricular filling or outflow or both.&#xD;
&#xD;
          -  Severe hepatic impairment (ALAT/ASAT&gt;400U/L)&#xD;
&#xD;
          -  Patients will be excluded if the treating physician judges that study participation is&#xD;
             undesirable for medical, medical-ethical or other reasons&#xD;
&#xD;
          -  Known history of Torsades de Pointes&#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>Jos Le Noble, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>VieCuri Medical Centre</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>VieCuri Medical Center</name>
      <address>
        <city>Venlo</city>
        <state>Limburg</state>
        <zip>NL-5912 BL</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>September 2016</verification_date>
  <study_first_submitted>October 3, 2012</study_first_submitted>
  <study_first_submitted_qc>October 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 1, 2012</study_first_posted>
  <last_update_submitted>September 26, 2016</last_update_submitted>
  <last_update_submitted_qc>September 26, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 27, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>VieCuri Medical Centre</investigator_affiliation>
    <investigator_full_name>Dr. Jos le Noble</investigator_full_name>
    <investigator_title>PhD, MD</investigator_title>
  </responsible_party>
  <keyword>Renal</keyword>
  <keyword>Acute Kidney Injury</keyword>
  <keyword>AKI</keyword>
  <keyword>Levosimendan</keyword>
  <keyword>Simdax</keyword>
  <keyword>Renal perfusion</keyword>
  <keyword>Mortality</keyword>
  <keyword>Renal flow</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Kidney Injury</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>Simendan</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/NCT01720030
org study id: Levosimendan in AKI Study
nct id: NCT01720030
lead sponsor: 
collaborator: 
has dmc: Yes
We hypothesise that levosimendan will have a positive influence on renal function during
      acute kidney injury in adult intensive care patients.
The purpose of this trial is to evaluate whether the use of levosimendan is able to improve
      renal function.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change in renal function
time frame: Baseline and every 24 hours until end ICU stay
description: Daily analysis of kidney function expressed in endogenous creatinine clearance
arm group label: Conventional therapy
arm group type: Placebo Comparator
description: Standard of care as protocolized locally
arm group label: Levosimendan
arm group type: Experimental
description: The experimental group receives standard treatment supplemented by levosimendan (0.2 µg/kg/min) for 24 hours within 36 hrs following onset of AKI.
intervention type: Drug
intervention name: Levosimendan
description: Verum therapy
arm group label: Levosimendan
other name: Simdax (R)
intervention type: Drug
intervention name: Conventional therapy
description: Placebo therapy to safeguard blinding
arm group label: Conventional therapy
other name: Standard care plus placebo comparator
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jos Le Noble, MD PhD
role: Principal Investigator
affiliation: VieCuri Medical Centre
facility: 
country: Netherlands
responsible party type: Principal Investigator
investigator affiliation: VieCuri Medical Centre
investigator full name: Dr. Jos le Noble
investigator title: PhD, MD
mesh term: Acute Kidney Injury
mesh term: Wounds and Injuries
mesh term: Simendan