<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/NCT04411472</url>
  </required_header>
  <id_info>
    <org_study_id>AP-recAP-AKI-03-01</org_study_id>
    <nct_id>NCT04411472</nct_id>
  </id_info>
  <brief_title>(Revival) Study to Investigate the Efficacy and Safety of Alkaline Phosphatase in Patients With Sepsis-Associated AKI</brief_title>
  <official_title>A DB, Placebo-Controlled, Two-Arm Parallel-Group, Phase 3 RCT to Investigate the Efficacy and Safety of Recombinant Human Alkaline Phosphatase for Treatment of Patients With SA-AKI</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AM-Pharma</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AM-Pharma</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Clinical phase 3 study to investigate the effect of recAP on 28 day mortality in patients&#xD;
      admitted to the ICU with acute kidney injury that is caused by sepsis.&#xD;
&#xD;
      The study has three distinct SA-AKI trial populations:&#xD;
&#xD;
        1. The main trial population: Patients with a pre-AKI reference eGFR ≥45 mL/min/1.73 m2 and&#xD;
           no proven or suspected SARS-CoV-2 at time of randomization.&#xD;
&#xD;
        2. A 'moderate' CKD population: Patients with a pre-AKI reference eGFR ≥25 and &lt;45&#xD;
           mL/min/1.73 m2 and no proven or suspected SARS-CoV-2 at time of randomization.&#xD;
&#xD;
        3. A Corona Virus Disease 2019 (COVID-19) population: Patients with proven or suspected&#xD;
           SARS-CoV-2 at time of randomization with or without 'moderate' CKD. For patients in this&#xD;
           population, COVID-19 should be the main cause of SA-AKI.&#xD;
&#xD;
      In the main study population approximately 1400 patients will be enrolled and in the two&#xD;
      cohorts with moderate CKD and COVID-19 each up to 100 patients.&#xD;
&#xD;
      There are two arms in the study, one with active treatment and one with an inactive compound&#xD;
      (placebo). Treatment is by 1 hour intravenous infusion, for three days. Patients are followed&#xD;
      up for 28 days to see if there is an improvement on mortality, and followed for 90 and 180&#xD;
      days for mortality and other outcomes e.g. long-term kidney function and quality of life.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Sepsis is the leading cause of acute kidney injury (AKI) and a major cause of death. Patients&#xD;
      with SA-AKI have a high mortality and morbidity and are at risk of developing chronic kidney&#xD;
      disease. AP is a homodimeric endogenous enzyme present in many cells and organs, e.g.,&#xD;
      intestines, placenta, liver, bone, kidney, and granulocytes. It exerts detoxifying effects&#xD;
      through dephosphorylation of endotoxins; pathogen associated molecular pattern molecules&#xD;
      (PAMPS e.g., lipopolysaccharide) and damage-associated molecular pattern molecules (DAMPS&#xD;
      e.g., adenosine tri- and di-phosphate). In animal models of sepsis and AKI, administration of&#xD;
      AP attenuates the inflammatory response, improves renal function and/or reduces mortality.&#xD;
&#xD;
      AM-Pharma B.V. is developing AP as a novel, recombinant chimeric human AP medicinal product,&#xD;
      called recAP, to be used as an intravenous infusion for the treatment of SA-AKI. In the Phase&#xD;
      2 trial STOP-AKI, a survival benefit was observed in the two highest dose groups, 0.8 mg/kg&#xD;
      and 1.6 mg/kg groups, compared to the placebo group. There were no safety or tolerability&#xD;
      concerns for any of the doses tested (0.4, 0.8 and 1.6 mg/kg). The 1.6 mg/kg recAP dose was&#xD;
      selected for this Phase 3 trial based on the significant survival benefit observed. PK/PD&#xD;
      simulations also confirmed this dose to have the most pronounced treatment effect.&#xD;
&#xD;
      The primary objective of this Phase 3 trial is to confirm the mortality benefit seen in&#xD;
      STOP-AKI by demonstrating a reduction in 28 day all cause mortality in patients with SA-AKI&#xD;
      treated with 1.6 mg/kg recAP.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The Data Monitoring Committee (DMC) concluded that the pre-specified futility threshold was met&#xD;
    and that there was no safety concern.&#xD;
  </why_stopped>
  <start_date type="Actual">November 2, 2020</start_date>
  <completion_date type="Actual">August 18, 2022</completion_date>
  <primary_completion_date type="Actual">August 18, 2022</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <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>28-day all-cause mortality</measure>
    <time_frame>28 days</time_frame>
    <description>To demonstrate an effect of recAP on 28 day all cause mortality</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To investigate the effect of recAP on long-term Major Adverse Kidney Events (MAKE).</measure>
    <time_frame>90 Days</time_frame>
    <description>MAKE 90: dead by Day 90 or on Renal Replacement Therapy (RRT) at Day 90 or ≥25% decline in estimated glomerular filtration rate (eGFR) on both Day 28 and Day 90 relative to the known or assumed pre-AKI reference level.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To investigate the effect of recAP on use of organ support, i.e., mechanical ventilation (MV), Renal Replacement Therapy (RRT), vasopressors or inotropes.</measure>
    <time_frame>28 days</time_frame>
    <description>Days alive and free of organ support through Day 28, i.e., days alive with no MV, RRT, vasopressors or inotropes (with death within 28 days counting as zero days).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To investigate the effect of recAP on length of stay (LOS) in ICU.</measure>
    <time_frame>28 days</time_frame>
    <description>Days alive and out of the ICU through Day 28 (with death within 28 days counting as zero days).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To investigate the effect of recAP on 90-day allcause mortality</measure>
    <time_frame>90 days</time_frame>
    <description>Time to death through Day 90.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">676</enrollment>
  <condition>Acute Kidney Injury Due to Sepsis</condition>
  <arm_group>
    <arm_group_label>active</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>recombinant human alkaline phosphatase 1.6mg/kg 3 daily 1 hour infusions</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>matching placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Recombinant human alkaline phosphatase</intervention_name>
    <description>patients with SA-AKI are randomly assigned in a 1:1 ratio to either placebo or 1.6 mg/kg recAP.</description>
    <arm_group_label>active</arm_group_label>
    <other_name>ilofotase alfa</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo</description>
    <arm_group_label>placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. 18 years or older.&#xD;
&#xD;
          2. In the ICU or intermediate care unit for clinical reasons.&#xD;
&#xD;
          3. Have sepsis requiring vasopressor (norepinephrine, epinephrine, dopamine,&#xD;
             phenylephrine, vasopressin, or angiotensin II) therapy, i.e.:&#xD;
&#xD;
               1. suspected or proven bacterial or viral infection. and&#xD;
&#xD;
               2. on vasopressor therapy (≥0.1 µg/kg/min norepinephrine or equivalent) for&#xD;
                  sepsis-induced hypotension for at least one hour despite adequate fluid&#xD;
                  resuscitation according to clinical judgement. Following the initial one hour on&#xD;
                  at least 0.1 µg/kg/min norepinephrine or equivalent, any dose of vasopressor&#xD;
                  counts as vasopressor therapy.&#xD;
&#xD;
             The combination of a) and b) automatically ensures that patients fulfill the Sepsis 3&#xD;
             criteria as 0.1 µg/kg/min norepinephrine corresponds to a score of +4 on the&#xD;
             Cardiovascular sub-score of the SOFA score.&#xD;
&#xD;
          4. Have AKI according to at least one of the below KDIGO criteria, a to d:&#xD;
&#xD;
               1. An absolute increase in serum or plasma creatinine (CR) by ≥0.3 mg/dL (≥26.5&#xD;
                  µmol/L) within 48 hours.&#xD;
&#xD;
                  or&#xD;
&#xD;
               2. A relative increase in CR to ≥1.5 times the pre-AKI reference CR value which is&#xD;
                  known or presumed to have occurred within prior 7 days.&#xD;
&#xD;
                  or&#xD;
&#xD;
               3. A decrease in urinary output to &lt;0.5 mL/kg/hour for a minimum of 6 hours&#xD;
                  following adequate fluid resuscitation.&#xD;
&#xD;
             or d) If the patient does not have a known history of CKD and there is no pre-AKI&#xD;
             reference CR value available from the past 12 months available from the past 12&#xD;
             months: a CR value greater or equal to the levels presented in Table 1, with the&#xD;
             increase in CR presumed to have occurred within prior 7 days.&#xD;
&#xD;
          5. Provision of signed and dated ICF in accordance with local regulations.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. a) At sites where enrolment of 'moderate' CKD patients is allowed, patients with&#xD;
             'severe' CKD defined as a pre-AKI reference eGFR &lt;25 mL/min/1.73 m2 are excluded.&#xD;
&#xD;
               -  For patients with known CKD, the most recent eGFR prior to index hospitalization&#xD;
                  needs to be documented as ≥25 mL/min/1.73 m2.&#xD;
&#xD;
               -  For patients with known CKD but no known eGFR prior to hospitalization,&#xD;
                  presentation eGFR between 25-60 mL/min/1.73 m2 can also be used to rule out&#xD;
                  'severe' CKD.&#xD;
&#xD;
                  b) At sites where enrolment of 'moderate' CKD patients is NOT allowed, patients&#xD;
                  with 'moderate' and 'severe' CKD defined as a pre-AKI reference eGFR &lt;45&#xD;
                  mL/min/1.73 m2 are excluded.&#xD;
&#xD;
               -  For patients with known CKD, the most recent eGFR prior to index hospitalization&#xD;
                  needs to be documented as ≥45 mL/min/1.73 m2.&#xD;
&#xD;
               -  For patients with known CKD but no known eGFR prior to hospitalization,&#xD;
                  presentation eGFR between 45-60 mL/min/1.73 m2 can also be used to rule out&#xD;
                  'moderate' and 'severe' CKD.&#xD;
&#xD;
          2. Advanced chronic liver disease, defined as a Child-Pugh score of 10 to 15 (Class C).&#xD;
&#xD;
          3. Acute pancreatitis without proven infection.&#xD;
&#xD;
          4. Urosepsis related to suspected or proven urinary tract obstruction.&#xD;
&#xD;
          5. Main cause of AKI not sepsis.&#xD;
&#xD;
          6. Proven or suspected SARS-CoV-2 infection. NOTE: This exclusion criterion does not&#xD;
             apply to patients in the COVID-19 population, in which COVID-19 should be the main&#xD;
             cause of SA-AKI.&#xD;
&#xD;
          7. Severe burns requiring ICU treatment.&#xD;
&#xD;
          8. Severely immunosuppressed, e.g. due to:&#xD;
&#xD;
               -  hematopoietic cell transplantation within past 6 months prior to Screening or&#xD;
                  acute or chronic graft-versus-host disease&#xD;
&#xD;
               -  solid organ transplantation&#xD;
&#xD;
               -  leukopenia not related to sepsis, i.e., preceding sepsis&#xD;
&#xD;
               -  Human Immunodeficiency Virus (HIV)/Acquired Immune Deficiency Syndrome (AIDS)&#xD;
&#xD;
               -  receiving chemotherapy within 30 days prior to Screening.&#xD;
&#xD;
          9. At high risk of being LTFU, e.g., due to known current or recent (within the last 6&#xD;
             months) IV drug abuse or known to be homeless.&#xD;
&#xD;
         10. Limitations to use of mechanical ventilation (MV), RRT or vasopressors and inotropes&#xD;
             (NOTE: limitation of cardiopulmonary resuscitation (CPR) only is not an exclusion&#xD;
             criterion).&#xD;
&#xD;
         11. Previous administration of recAP.&#xD;
&#xD;
         12. Use of a non-marketed drug within the last month or concurrent or planned&#xD;
             participation in a clinical trial for a non-marketed drug or device. (NOTE:&#xD;
             Co-enrollment or concurrent participation in observational, non-interventional trials&#xD;
             using no protocolized treatments or procedures are always allowed. Co-enrollment or&#xD;
             concurrent participation in trials using protocolized treatments or procedures, e.g.&#xD;
             blood draws, requires pre-approval by the TSC).&#xD;
&#xD;
         13. Current or planned extracorporeal membrane oxygenation (ECMO).&#xD;
&#xD;
         14. On RRT &gt;24 hours before start of trial drug.&#xD;
&#xD;
         15. No longer on vasopressor therapy at time of randomization.&#xD;
&#xD;
         16. On continuous vasopressor therapy for &gt;72 hours before start of trial drug.&#xD;
&#xD;
         17. Estimated glomerular filtration rate (eGFR) &gt;60 mL/min/1.73 m2 based on the most&#xD;
             recent available CR sample at time of screening (NOTE: will often be the sample used&#xD;
             to diagnose AKI). eGFR should be calculated using the Chronic Kidney Disease&#xD;
             Epidemiology Collaboration (CKD-EPI) formula. In Japan, the CKD-EPI formula with&#xD;
             Japanese coefficient should be used. If local regulations prohibit correcting for race&#xD;
             in the calculation of eGFR, it is acceptable to use the formula without correcting for&#xD;
             race.&#xD;
&#xD;
         18. Not feasible to start trial drug within:&#xD;
&#xD;
               1. 48 hours from AKI diagnosis, when AKI diagnosis precedes start of vasopressor&#xD;
                  therapy.&#xD;
&#xD;
                  or&#xD;
&#xD;
               2. 24 hours from AKI diagnosis, when AKI is diagnosed after start of vasopressor&#xD;
                  therapy.&#xD;
&#xD;
         19. Pregnant or nursing women.&#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>Annelies Legters</last_name>
    <role>Study Director</role>
    <affiliation>AM-Pharma</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The University of Arizona Cancer Center</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85724-5057</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ronald Reagan UCLA Medical Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095-8358</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The George Washington University Medical Faculty Associates - Anesthesiology</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20037-2342</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emory Clinical Cardiovascular Research Institute</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322-1007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Glenbrook Hospital</name>
      <address>
        <city>Glenview</city>
        <state>Illinois</state>
        <zip>60026-1301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NorthShore Medical Group - Bannockburn</name>
      <address>
        <city>Highland Park</city>
        <state>Illinois</state>
        <zip>60035</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Kentucky College of Medicine (UKCM)</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40508-3215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regions Hospital</name>
      <address>
        <city>Saint Paul</city>
        <state>Minnesota</state>
        <zip>55101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of New Mexico School of Medicine</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87131</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wake Forest Baptist Medical Center</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Cincinnati Cancer Institute</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Ohio State University - Dorothy M. Davis Heart and Lung Research Institute</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UPMC CancerCenter at Magee - Womens Hospital</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213-3108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UPMC Presbyterian</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213-3108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Virginia Health System</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22908-0817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Froedtert &amp; the Medical College of Wisconsin Froedtert Hospital</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53226-3522</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Flinders Medical Centre</name>
      <address>
        <city>Bedford Park</city>
        <zip>5042</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bendigo Hospital</name>
      <address>
        <city>Bendigo</city>
        <zip>3550</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Footscray Hospital</name>
      <address>
        <city>Footscray</city>
        <zip>3011</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Austin Hospital</name>
      <address>
        <city>Melbourne</city>
        <zip>3084</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>John Hunter Hospital</name>
      <address>
        <city>New Lambton Heights</city>
        <zip>2305</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sunshine Hospital ICU - Western Hospital</name>
      <address>
        <city>Saint Albans</city>
        <zip>3021</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gold Coast University Hospital (GCUH)</name>
      <address>
        <city>Southport</city>
        <zip>4215</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medizinische Universitaet Graz - Klinik fuer Innere Medizin</name>
      <address>
        <city>Graz</city>
        <zip>8036</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medizinische Universitaet Innsbruck - Universitaetsklinik fuer Innere Medizin I</name>
      <address>
        <city>Innsbruck</city>
        <zip>6020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medizinische Universität Innsbruck</name>
      <address>
        <city>Innsbruck</city>
        <zip>6020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire Brugmann</name>
      <address>
        <city>Brussels</city>
        <zip>1020</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire (CHU) de Charleroi - Hopital Civil Marie Curie</name>
      <address>
        <city>Charleroi</city>
        <zip>6042</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ziekenhuis Oost-Limburg</name>
      <address>
        <city>Genk</city>
        <zip>3600</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitair Ziekenhuis Gent</name>
      <address>
        <city>Gent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitair Ziekenhuis Brussel</name>
      <address>
        <city>Jette</city>
        <zip>1090</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital de JOLIMONT</name>
      <address>
        <city>La Louvière</city>
        <zip>7100</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique Saint-Pierre- Ottignies</name>
      <address>
        <city>Ottignies</city>
        <zip>1340</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cliniques Universitaires Saint-Luc</name>
      <address>
        <city>Woluwe-Saint-Lambert</city>
        <zip>1200</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU UCL Namur - Mont-Godinne</name>
      <address>
        <city>Yvoir</city>
        <zip>5530</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peter Lougheed Centre</name>
      <address>
        <city>Calgary</city>
        <zip>T1Y 6J4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foothills Medical Centre</name>
      <address>
        <city>Calgary</city>
        <zip>T2N 2T9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rockyview General Hospital</name>
      <address>
        <city>Calgary</city>
        <zip>T2V 1P9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alberta Health Services - South Health Campus Hospital</name>
      <address>
        <city>Calgary</city>
        <zip>T3M 1M4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Ottawa Hospital - General Campus</name>
      <address>
        <city>Ottawa</city>
        <zip>K1H 8L6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Ottawa Hospital - Civic Campus</name>
      <address>
        <city>Ottawa</city>
        <zip>K1Y 4E9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital de l'Enfant-Jésus</name>
      <address>
        <city>Québec</city>
        <zip>G1J 1Z4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Paul's Hospital</name>
      <address>
        <city>Vancouver</city>
        <zip>V6Z 1Y6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Jubilee Hospital (RJH)</name>
      <address>
        <city>Victoria</city>
        <zip>V8R 1J8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Victoria General Hospital (VGH)</name>
      <address>
        <city>Victoria</city>
        <zip>V8R 1J8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aalborg Universitetshospital</name>
      <address>
        <city>Aalborg</city>
        <zip>9000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aarhus University Hospital</name>
      <address>
        <city>Aarhus N</city>
        <zip>8200</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Herning Regional Hospital</name>
      <address>
        <city>Herning</city>
        <zip>7400</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nordsjællands Hospital</name>
      <address>
        <city>Hillerød</city>
        <zip>3400</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rigshospitalet</name>
      <address>
        <city>København</city>
        <zip>2100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sjaellands Universitetshospital, Koge - Kardiologisk Afdeling</name>
      <address>
        <city>Køge</city>
        <zip>4600</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Odense Universitetshospital</name>
      <address>
        <city>Odense C</city>
        <zip>5000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regionshospitalet Randers</name>
      <address>
        <city>Randers</city>
        <zip>8930</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Slagelse Sygehus</name>
      <address>
        <city>Slagelse</city>
        <zip>4200</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospitalsenhed Midt</name>
      <address>
        <city>Viborg</city>
        <zip>8800</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Helsinki University Central Hospital (HUCH)</name>
      <address>
        <city>Helsinki</city>
        <zip>290</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tampere University Hospital</name>
      <address>
        <city>Tampere</city>
        <zip>33521</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Turku University Hospital (TYKS)</name>
      <address>
        <city>Turku</city>
        <zip>20521</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire d'Angers</name>
      <address>
        <city>Angers Cedex</city>
        <zip>49933</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier d'Argenteuil</name>
      <address>
        <city>Argenteuil Cedex</city>
        <zip>95107</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier de Bethune Germon et Gauthier</name>
      <address>
        <city>Béthune</city>
        <zip>62408</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier René-Dubos</name>
      <address>
        <city>Cergy-Pontoise</city>
        <zip>95303</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Dijon - Hôpital François Mitterrand</name>
      <address>
        <city>Dijon</city>
        <zip>21079</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Départemental de Vendée - Les Oudairies</name>
      <address>
        <city>La Roche-sur-Yon</city>
        <zip>85000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Bicêtre</name>
      <address>
        <city>Le Kremlin-Bicêtre</city>
        <zip>94270</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier du Mans</name>
      <address>
        <city>Le Mans</city>
        <zip>72000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Limoges - Hôpital Dupuytren</name>
      <address>
        <city>Limoges Cedex</city>
        <zip>87000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Nancy</name>
      <address>
        <city>Nancy</city>
        <zip>54000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Nantes - Hôtel-Dieu</name>
      <address>
        <city>Nantes</city>
        <zip>44000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Nimes - Hopital Universitaire Caremeau</name>
      <address>
        <city>Nîmes cedex 9</city>
        <zip>30029</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital La Source</name>
      <address>
        <city>Orléans</city>
        <zip>45067</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Lariboisière</name>
      <address>
        <city>Paris</city>
        <zip>75010</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpitaux Universitaires de Strasbourg - Hôpital Civil</name>
      <address>
        <city>Strasbourg</city>
        <zip>67091</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHRU de Tours - Hôpital Bretonneau</name>
      <address>
        <city>Tours cedex 9</city>
        <zip>37044</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Aachen</name>
      <address>
        <city>Aachen</city>
        <zip>52074</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Hamburg-Eppendorf (UKE)</name>
      <address>
        <city>Hamburg</city>
        <zip>20246</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Jena - Klinik fur Neurologie</name>
      <address>
        <city>Jena</city>
        <zip>7747</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Leipzig - Klinik und Poliklinik fuer Gastroenterologie und Rheumatologie</name>
      <address>
        <city>Leipzig</city>
        <zip>4103</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Münster</name>
      <address>
        <city>Münster</city>
        <zip>48149</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National University of Ireland, Galway</name>
      <address>
        <city>Galway</city>
        <state>G</state>
        <zip>H91 YR71</zip>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. James's Hospital</name>
      <address>
        <city>Dublin</city>
        <zip>D08 NHY1</zip>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tallaght University Hospital</name>
      <address>
        <city>Dublin</city>
        <zip>D24NR0A</zip>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Vincent's University Hospital</name>
      <address>
        <city>Dublin</city>
        <zip>Dublin 4</zip>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tokyo Medical University Hachioji Medical Center</name>
      <address>
        <city>Hachioji-Shi</city>
        <zip>193-0998</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hiroshima University Hospital</name>
      <address>
        <city>Hiroshima-shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aso Iizuka Hospital</name>
      <address>
        <city>Izuka-shi</city>
        <zip>820-8505</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rinku General Medical Center</name>
      <address>
        <city>Izumisano-Shi</city>
        <zip>598-8577</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nara Medical University Hospital</name>
      <address>
        <city>Kashihara-Shi</city>
        <zip>634-8522</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Kumamoto Medical Center</name>
      <address>
        <city>Kumamoto-Shi</city>
        <zip>860-0008</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Omihachiman Community Medical Center</name>
      <address>
        <city>Omihachiman-Shi</city>
        <zip>523-0082</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Osaka City General Hospital</name>
      <address>
        <city>Osaka-Shi</city>
        <zip>534-0021</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Osaka Police Hospital</name>
      <address>
        <city>Osaka-shi</city>
        <zip>543-0035</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fujita Health University Hospital</name>
      <address>
        <city>Toyoake-Shi</city>
        <zip>470-1192</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization - Yokohama Medical Center</name>
      <address>
        <city>Yokohama-Shi</city>
        <zip>245-8575</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jeroen Bosch Ziekenhuis lokatie GZG</name>
      <address>
        <city>'s-Hertogenbosch</city>
        <state>NB</state>
        <zip>5223 GZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Amsterdam UMC - VUMC</name>
      <address>
        <city>Amsterdam</city>
        <zip>1081 HV</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ziekenhuis Gelderse Vallei</name>
      <address>
        <city>Ede</city>
        <zip>6716 RP</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medisch Spectrum Twente</name>
      <address>
        <city>Enschede</city>
        <zip>KZ 7512</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zuyderland Medisch Centrum, Heerlen</name>
      <address>
        <city>Heerlen</city>
        <zip>Heerlen</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Radboud UMC</name>
      <address>
        <city>Nijmegen</city>
        <zip>6500 HB</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Canisius-Wilhelmina Ziekenhuis</name>
      <address>
        <city>Nijmegen</city>
        <zip>6532 SZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wellington Hospital</name>
      <address>
        <city>Wellington</city>
        <state>WGN</state>
        <zip>6021</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Auckland City Hospital</name>
      <address>
        <city>Auckland</city>
        <zip>1023</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Middlemore Clinical Trials</name>
      <address>
        <city>Auckland</city>
        <zip>2025</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Christchurch Hospital</name>
      <address>
        <city>Christchurch</city>
        <zip>8140</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dunedin Hospital</name>
      <address>
        <city>Dunedin</city>
        <zip>9016</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Auckland City Hospital</name>
      <address>
        <city>Grafton</city>
        <zip>1023</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hawke's Bay Hospital Soldiers' Memorial</name>
      <address>
        <city>Hastings</city>
        <zip>4172</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lakes District Health Board - Rotorua Hospital</name>
      <address>
        <city>Rotorua</city>
        <zip>3046</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari Germans Trias i Pujol</name>
      <address>
        <city>Badalona</city>
        <zip>8916</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital del Mar</name>
      <address>
        <city>Barcelona</city>
        <zip>8003</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Vall d'Hebron</name>
      <address>
        <city>Barcelona</city>
        <zip>8035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari de Bellvitge (IDIBELL)</name>
      <address>
        <city>Barcelona</city>
        <zip>8907</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari de Girona Doctor Josep Trueta</name>
      <address>
        <city>Girona</city>
        <zip>17007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clínico San Carlos</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Parc Taulí Sabadell Hospital Universitari</name>
      <address>
        <city>Sabadell</city>
        <zip>8208</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitat de Barcelona - Hospital Universitari Mutua Terrassa (HUMT)</name>
      <address>
        <city>Terrassa</city>
        <zip>8221</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University College London Hospitals NHS Foundation Trust - University College Hospital</name>
      <address>
        <city>London</city>
        <state>LND</state>
        <zip>NW1 2BU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital of Wales</name>
      <address>
        <city>Cardiff</city>
        <zip>CF14 4XW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Liverpool University Hospital</name>
      <address>
        <city>Liverpool</city>
        <zip>L7 8XP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guy's and St Thomas' NHS Foundation Trust - St Thomas' Hospital</name>
      <address>
        <city>London</city>
        <zip>SE1 7EH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Plymouth Hospitals NHS Trust - Derriford Hospital</name>
      <address>
        <city>Plymouth</city>
        <zip>PL6 8DH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Austria</country>
    <country>Belgium</country>
    <country>Canada</country>
    <country>Denmark</country>
    <country>Finland</country>
    <country>France</country>
    <country>Germany</country>
    <country>Ireland</country>
    <country>Japan</country>
    <country>Netherlands</country>
    <country>New Zealand</country>
    <country>Spain</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>May 28, 2020</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>June 6, 2023</last_update_submitted>
  <last_update_submitted_qc>June 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sepsis</mesh_term>
    <mesh_term>Acute Kidney Injury</mesh_term>
  </condition_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/NCT04411472
org study id: AP-recAP-AKI-03-01
nct id: NCT04411472
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
Clinical phase 3 study to investigate the effect of recAP on 28 day mortality in patients
      admitted to the ICU with acute kidney injury that is caused by sepsis.

      The study has three distinct SA-AKI trial populations:

        1. The main trial population: Patients with a pre-AKI reference eGFR ≥45 mL/min/1.73 m2 and
           no proven or suspected SARS-CoV-2 at time of randomization.

        2. A 'moderate' CKD population: Patients with a pre-AKI reference eGFR ≥25 and <45
           mL/min/1.73 m2 and no proven or suspected SARS-CoV-2 at time of randomization.

        3. A Corona Virus Disease 2019 (COVID-19) population: Patients with proven or suspected
           SARS-CoV-2 at time of randomization with or without 'moderate' CKD. For patients in this
           population, COVID-19 should be the main cause of SA-AKI.

      In the main study population approximately 1400 patients will be enrolled and in the two
      cohorts with moderate CKD and COVID-19 each up to 100 patients.

      There are two arms in the study, one with active treatment and one with an inactive compound
      (placebo). Treatment is by 1 hour intravenous infusion, for three days. Patients are followed
      up for 28 days to see if there is an improvement on mortality, and followed for 90 and 180
      days for mortality and other outcomes e.g. long-term kidney function and quality of life.
Sepsis is the leading cause of acute kidney injury (AKI) and a major cause of death. Patients
      with SA-AKI have a high mortality and morbidity and are at risk of developing chronic kidney
      disease. AP is a homodimeric endogenous enzyme present in many cells and organs, e.g.,
      intestines, placenta, liver, bone, kidney, and granulocytes. It exerts detoxifying effects
      through dephosphorylation of endotoxins; pathogen associated molecular pattern molecules
      (PAMPS e.g., lipopolysaccharide) and damage-associated molecular pattern molecules (DAMPS
      e.g., adenosine tri- and di-phosphate). In animal models of sepsis and AKI, administration of
      AP attenuates the inflammatory response, improves renal function and/or reduces mortality.

      AM-Pharma B.V. is developing AP as a novel, recombinant chimeric human AP medicinal product,
      called recAP, to be used as an intravenous infusion for the treatment of SA-AKI. In the Phase
      2 trial STOP-AKI, a survival benefit was observed in the two highest dose groups, 0.8 mg/kg
      and 1.6 mg/kg groups, compared to the placebo group. There were no safety or tolerability
      concerns for any of the doses tested (0.4, 0.8 and 1.6 mg/kg). The 1.6 mg/kg recAP dose was
      selected for this Phase 3 trial based on the significant survival benefit observed. PK/PD
      simulations also confirmed this dose to have the most pronounced treatment effect.

      The primary objective of this Phase 3 trial is to confirm the mortality benefit seen in
      STOP-AKI by demonstrating a reduction in 28 day all cause mortality in patients with SA-AKI
      treated with 1.6 mg/kg recAP.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: 28-day all-cause mortality
time frame: 28 days
description: To demonstrate an effect of recAP on 28 day all cause mortality
measure: To investigate the effect of recAP on long-term Major Adverse Kidney Events (MAKE).
time frame: 90 Days
description: MAKE 90: dead by Day 90 or on Renal Replacement Therapy (RRT) at Day 90 or ≥25% decline in estimated glomerular filtration rate (eGFR) on both Day 28 and Day 90 relative to the known or assumed pre-AKI reference level.
measure: To investigate the effect of recAP on use of organ support, i.e., mechanical ventilation (MV), Renal Replacement Therapy (RRT), vasopressors or inotropes.
time frame: 28 days
description: Days alive and free of organ support through Day 28, i.e., days alive with no MV, RRT, vasopressors or inotropes (with death within 28 days counting as zero days).
measure: To investigate the effect of recAP on length of stay (LOS) in ICU.
time frame: 28 days
description: Days alive and out of the ICU through Day 28 (with death within 28 days counting as zero days).
measure: To investigate the effect of recAP on 90-day allcause mortality
time frame: 90 days
description: Time to death through Day 90.
arm group label: active
arm group type: Experimental
description: recombinant human alkaline phosphatase 1.6mg/kg 3 daily 1 hour infusions
arm group label: placebo
arm group type: Placebo Comparator
description: matching placebo
intervention type: Biological
intervention name: Recombinant human alkaline phosphatase
description: patients with SA-AKI are randomly assigned in a 1:1 ratio to either placebo or 1.6 mg/kg recAP.
arm group label: active
other name: ilofotase alfa
intervention type: Other
intervention name: Placebo
description: Placebo
arm group label: placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Annelies Legters
role: Study Director
affiliation: AM-Pharma
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country: Australia
country: Austria
country: Belgium
country: Canada
country: Denmark
country: Finland
country: France
country: Germany
country: Ireland
country: Japan
country: Netherlands
country: New Zealand
country: Spain
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Sepsis
mesh term: Acute Kidney Injury