<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/NCT04469907</url>
  </required_header>
  <id_info>
    <org_study_id>D6401C00008</org_study_id>
    <nct_id>NCT04469907</nct_id>
  </id_info>
  <brief_title>Study to Assess the Pharmacokinetics and Safety of AZD9977 in Participants With Renal Impairment</brief_title>
  <official_title>A Single Dose, Non-Randomized, Open-Label, Parallel Group Study to Assess the Pharmacokinetics, Safety and Tolerability of AZD9977 in Participants With Renal Impairment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AstraZeneca</source>
  <oversight_info>
    <has_dmc>No</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>
      This is a single dose, non-randomized, open-label, parallel group study. The study will be&#xD;
      conducted in participants with severe renal impairment and compared with matched participants&#xD;
      with normal renal function. The duration of the study for an individual participant from&#xD;
      Screening to Follow-up will be approximately 5 weeks.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will have 4 cohorts, consisting of participants with severe renal impairment who&#xD;
      are not on dialysis (Cohort 1), moderate renal impairment (Cohort 2), mild renal impairment&#xD;
      (Cohort 3) and participants with normal renal function (Cohort 4). Following completion of&#xD;
      Cohort 1 and Cohort 4, pharmacokinetics (PK) and safety data will be reviewed and a decision&#xD;
      will be made whether to study unmatched participants with moderate and mild renal impairment&#xD;
      (Cohorts 2 and 3, respectively).&#xD;
&#xD;
      Participants will be screened up to 21 days before administration of study drug. Eligible&#xD;
      participants will be admitted to the clinical unit either on the evening of Day -2 or on the&#xD;
      morning of Day -1. Each participant will receive a single oral dose of the study drug under&#xD;
      fasted conditions on Day 1. Participants will be required to remain resident in the clinical&#xD;
      unit until the morning of Day 3 but, if participants prefer, may also remain resident until&#xD;
      all PK and other study procedures are completed on Day 7. This decision to extend residency&#xD;
      will be made at the discretion of the principal investigator. If participants do check out on&#xD;
      Day 3, participants will then return to the unit, as scheduled, for collection of PK samples&#xD;
      and safety assessments, with a final Follow-up Visit on Day 14.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 22, 2020</start_date>
  <completion_date type="Actual">October 28, 2021</completion_date>
  <primary_completion_date type="Actual">October 28, 2021</primary_completion_date>
  <phase>Phase 1</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>Maximum observed plasma concentration (Cmax)</measure>
    <time_frame>Day 1 to 3 (Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 16, 20, 24, 36, and 48 hours post-dose), Day 4 to 7</time_frame>
    <description>To assess the PK of AZD9977 following administration of AZD9977</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the plasma concentration-time curve from time zero to infinity (AUC)</measure>
    <time_frame>Day 1 to 3 (Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 16, 20, 24, 36, and 48 hours post-dose), Day 4 to 7</time_frame>
    <description>To assess the PK of AZD9977 following administration of AZD9977</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC0-t)</measure>
    <time_frame>Day 1 to 3 (Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 16, 20, 24, 36, and 48 hours post-dose), Day 4 to 7</time_frame>
    <description>To assess the PK of AZD9977 following administration of AZD9977</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to reach maximum observed plasma concentration (tmax)</measure>
    <time_frame>Day 1 to 3 (Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 16, 20, 24, 36, and 48 hours post-dose), Day 4 to 7</time_frame>
    <description>To assess the PK of AZD9977 following administration of AZD9977</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Half-life associated with terminal slope of a semi-logarithmic concentration time curve (t½λz)</measure>
    <time_frame>Day 1 to 3 (Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 16, 20, 24, 36, and 48 hours post-dose), Day 4 to 7</time_frame>
    <description>To assess the PK of AZD9977 following administration of AZD9977</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Terminal elimination rate constant (λz)</measure>
    <time_frame>Day 1 to 3 (Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 16, 20, 24, 36, and 48 hours post-dose), Day 4 to 7</time_frame>
    <description>To assess the PK of AZD9977 following administration of AZD9977</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Apparent total body clearance of drug from plasma after oral administration (CL/F)</measure>
    <time_frame>Day 1 to 3 (Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 16, 20, 24, 36, and 48 hours post-dose), Day 4 to 7</time_frame>
    <description>To assess the PK of AZD9977 following administration of AZD9977</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Non-renal clearance of drug from plasma after oral administration (CLNR/F)</measure>
    <time_frame>Day 1 to 3 (Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 16, 20, 24, 36, and 48 hours post-dose), Day 4 to 7</time_frame>
    <description>To assess the PK of AZD9977 following administration of AZD9977</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Apparent volume of distribution during the terminal phase after oral administration (Vz/F)</measure>
    <time_frame>Day 1 to 3 (Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 16, 20, 24, 36, and 48 hours post-dose), Day 4 to 7</time_frame>
    <description>To assess the PK of AZD9977 following administration of AZD9977</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean residence time (MRT)</measure>
    <time_frame>Day 1 to 3 (Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 16, 20, 24, 36, and 48 hours post-dose), Day 4 to 7</time_frame>
    <description>To assess the PK of AZD9977 following administration of AZD9977</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Renal clearance of the drug from plasma (CLR)</measure>
    <time_frame>Day 1 to 3 (Pre-dose, 0-4, 4-8, 8-12, 12-24, 24-36, and 36-48 hours post-dose)</time_frame>
    <description>To assess the PK of AZD9977 following administration of AZD9977</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cumulative amount of unchanged drug excreted into the urine (Ae)</measure>
    <time_frame>Day 1 to 3 (Pre-dose, 0-4, 4-8, 8-12, 12-24, 24-36, and 36-48 hours post-dose)</time_frame>
    <description>To assess the PK of AZD9977 following administration of AZD9977</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fraction of the drug excreted into the urine (fe)</measure>
    <time_frame>Day 1 to 3 (Pre-dose, 0-4, 4-8, 8-12, 12-24, 24-36, and 36-48 hours post-dose)</time_frame>
    <description>To assess the PK of AZD9977 following administration of AZD9977</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants with adverse events and serious adverse events</measure>
    <time_frame>Day -2 to Day 14</time_frame>
    <description>To evaluate the safety and tolerability of AZD9977</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Estimated Glomerular Filtration Rate (eGFR)</measure>
    <time_frame>Screening, Day -1, Day 1 to 3 (Pre-dose, 4, 12, 24 , 36, and 48 hours)</time_frame>
    <description>To determine eGFR based on creatinine and cystatin C using CKD-EPI formula</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Renal Impairment</condition>
  <arm_group>
    <arm_group_label>Treatment - AZD9977</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>There are 4 cohorts in this arm based on renal function (mild, moderate, severe, and normal). Each cohort will have 8 participants.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AZD9977</intervention_name>
    <description>Participants will receive a single oral dose of AZD9977 under fasted conditions.</description>
    <arm_group_label>Treatment - AZD9977</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Healthy matched control participants only (Cohort 4):&#xD;
&#xD;
          1. Participants who are overtly healthy.&#xD;
&#xD;
          2. Stable renal function, with eGFR of ≥ 90 mL/min/1.73m^2.&#xD;
&#xD;
             Renally impaired participants only (Cohorts 1-3):&#xD;
&#xD;
          3. Participants who have renal impairment:&#xD;
&#xD;
               1. Cohort 1 participants with severe renal impairment must have an eGFR lesser than&#xD;
                  30 mL/min/1.73m^2 not on dialysis&#xD;
&#xD;
               2. Cohort 2 participants with moderate renal impairment must have an eGFR of greater&#xD;
                  than or equal to 30 to lesser than 60 mL/min/1.73m^2&#xD;
&#xD;
               3. Cohort 3 participants with mild renal impairment must have an eGFR of greater&#xD;
                  than or equal to 60 to lesser than 90 mL/min/1.73m^2.&#xD;
&#xD;
             All participants (Cohorts 1-4):&#xD;
&#xD;
          4. Body weight of at least 50 kg and BMI within the range greater than or equal to 18 to&#xD;
             lesser than or equal to 35 kg/m^2.&#xD;
&#xD;
          5. Male or female of non-childbearing potential.&#xD;
&#xD;
          6. Male participants should not donate sperm for the duration of the study.&#xD;
&#xD;
          7. Female participants must have a negative pregnancy test at time of study entry.&#xD;
&#xD;
          8. Capable of giving signed informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Healthy matched control participants only (Cohort 4):&#xD;
&#xD;
          1. Evidence of clinically significant cardiovascular, hematological, renal, endocrine,&#xD;
             pulmonary, gastrointestinal, hepatic, neurologic, psychiatric, inflammatory or&#xD;
             allergic disease.&#xD;
&#xD;
             Renally impaired participants only (Cohorts 1-3):&#xD;
&#xD;
          2. Renal transplant participants, participants on dialysis and those with a history of&#xD;
             acute kidney injury.&#xD;
&#xD;
             All participants (Cohorts 1-4):&#xD;
&#xD;
          3. Any positive result on Screening for serum hepatitis B surface antigen, hepatitis C&#xD;
             virus antibody, and human immunodeficiency virus antibody.&#xD;
&#xD;
          4. Known history of drug or alcohol abuse.&#xD;
&#xD;
          5. History of QT prolongation and arrhythmia.&#xD;
&#xD;
          6. Any moderate or potent inhibitors or inducers of CYP3A4.&#xD;
&#xD;
          7. Participants with a known hypersensitivity to AZD9977 or any of the excipients of the&#xD;
             product.&#xD;
&#xD;
          8. For women only - currently pregnant or breast-feeding.&#xD;
&#xD;
          9. A positive local diagnostic test result for severe acute respiratory syndrome&#xD;
             coronavirus 2 (SARS-CoV-2) at Screening, clinical signs and symptoms consistent with&#xD;
             COVID-19, or the patient has been previosuly hospitalised with COVID-19 infection.&#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>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Northridge</city>
        <state>California</state>
        <zip>91324</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>DeLand</city>
        <state>Florida</state>
        <zip>32720</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hialeah</city>
        <state>Florida</state>
        <zip>33014</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32809</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Blue Ash</city>
        <state>Ohio</state>
        <zip>45242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>New Zealand</country>
  </removed_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>June 19, 2020</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 14, 2020</study_first_posted>
  <last_update_submitted>March 10, 2022</last_update_submitted>
  <last_update_submitted_qc>March 10, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 11, 2022</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>Renal Insufficiency</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.&#xD;
Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.</ipd_description>
    <ipd_time_frame>AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.</ipd_time_frame>
    <ipd_access_criteria>When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.</ipd_access_criteria>
    <ipd_url>https://astrazenecagroup-dt.pharmacm.com/DT/Home</ipd_url>
  </patient_data>
  <!-- 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/NCT04469907
org study id: D6401C00008
nct id: NCT04469907
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This is a single dose, non-randomized, open-label, parallel group study. The study will be
      conducted in participants with severe renal impairment and compared with matched participants
      with normal renal function. The duration of the study for an individual participant from
      Screening to Follow-up will be approximately 5 weeks.
The study will have 4 cohorts, consisting of participants with severe renal impairment who
      are not on dialysis (Cohort 1), moderate renal impairment (Cohort 2), mild renal impairment
      (Cohort 3) and participants with normal renal function (Cohort 4). Following completion of
      Cohort 1 and Cohort 4, pharmacokinetics (PK) and safety data will be reviewed and a decision
      will be made whether to study unmatched participants with moderate and mild renal impairment
      (Cohorts 2 and 3, respectively).

      Participants will be screened up to 21 days before administration of study drug. Eligible
      participants will be admitted to the clinical unit either on the evening of Day -2 or on the
      morning of Day -1. Each participant will receive a single oral dose of the study drug under
      fasted conditions on Day 1. Participants will be required to remain resident in the clinical
      unit until the morning of Day 3 but, if participants prefer, may also remain resident until
      all PK and other study procedures are completed on Day 7. This decision to extend residency
      will be made at the discretion of the principal investigator. If participants do check out on
      Day 3, participants will then return to the unit, as scheduled, for collection of PK samples
      and safety assessments, with a final Follow-up Visit on Day 14.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Maximum observed plasma concentration (Cmax)
time frame: Day 1 to 3 (Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 16, 20, 24, 36, and 48 hours post-dose), Day 4 to 7
description: To assess the PK of AZD9977 following administration of AZD9977
measure: Area under the plasma concentration-time curve from time zero to infinity (AUC)
time frame: Day 1 to 3 (Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 16, 20, 24, 36, and 48 hours post-dose), Day 4 to 7
description: To assess the PK of AZD9977 following administration of AZD9977
measure: Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC0-t)
time frame: Day 1 to 3 (Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 16, 20, 24, 36, and 48 hours post-dose), Day 4 to 7
description: To assess the PK of AZD9977 following administration of AZD9977
measure: Time to reach maximum observed plasma concentration (tmax)
time frame: Day 1 to 3 (Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 16, 20, 24, 36, and 48 hours post-dose), Day 4 to 7
description: To assess the PK of AZD9977 following administration of AZD9977
measure: Half-life associated with terminal slope of a semi-logarithmic concentration time curve (t½λz)
time frame: Day 1 to 3 (Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 16, 20, 24, 36, and 48 hours post-dose), Day 4 to 7
description: To assess the PK of AZD9977 following administration of AZD9977
measure: Terminal elimination rate constant (λz)
time frame: Day 1 to 3 (Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 16, 20, 24, 36, and 48 hours post-dose), Day 4 to 7
description: To assess the PK of AZD9977 following administration of AZD9977
measure: Apparent total body clearance of drug from plasma after oral administration (CL/F)
time frame: Day 1 to 3 (Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 16, 20, 24, 36, and 48 hours post-dose), Day 4 to 7
description: To assess the PK of AZD9977 following administration of AZD9977
measure: Non-renal clearance of drug from plasma after oral administration (CLNR/F)
time frame: Day 1 to 3 (Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 16, 20, 24, 36, and 48 hours post-dose), Day 4 to 7
description: To assess the PK of AZD9977 following administration of AZD9977
measure: Apparent volume of distribution during the terminal phase after oral administration (Vz/F)
time frame: Day 1 to 3 (Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 16, 20, 24, 36, and 48 hours post-dose), Day 4 to 7
description: To assess the PK of AZD9977 following administration of AZD9977
measure: Mean residence time (MRT)
time frame: Day 1 to 3 (Pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 8, 12, 16, 20, 24, 36, and 48 hours post-dose), Day 4 to 7
description: To assess the PK of AZD9977 following administration of AZD9977
measure: Renal clearance of the drug from plasma (CLR)
time frame: Day 1 to 3 (Pre-dose, 0-4, 4-8, 8-12, 12-24, 24-36, and 36-48 hours post-dose)
description: To assess the PK of AZD9977 following administration of AZD9977
measure: Cumulative amount of unchanged drug excreted into the urine (Ae)
time frame: Day 1 to 3 (Pre-dose, 0-4, 4-8, 8-12, 12-24, 24-36, and 36-48 hours post-dose)
description: To assess the PK of AZD9977 following administration of AZD9977
measure: Fraction of the drug excreted into the urine (fe)
time frame: Day 1 to 3 (Pre-dose, 0-4, 4-8, 8-12, 12-24, 24-36, and 36-48 hours post-dose)
description: To assess the PK of AZD9977 following administration of AZD9977
measure: Number of participants with adverse events and serious adverse events
time frame: Day -2 to Day 14
description: To evaluate the safety and tolerability of AZD9977
measure: Estimated Glomerular Filtration Rate (eGFR)
time frame: Screening, Day -1, Day 1 to 3 (Pre-dose, 4, 12, 24 , 36, and 48 hours)
description: To determine eGFR based on creatinine and cystatin C using CKD-EPI formula
arm group label: Treatment - AZD9977
arm group type: Experimental
description: There are 4 cohorts in this arm based on renal function (mild, moderate, severe, and normal). Each cohort will have 8 participants.
intervention type: Drug
intervention name: AZD9977
description: Participants will receive a single oral dose of AZD9977 under fasted conditions.
arm group label: Treatment - AZD9977
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
country: New Zealand
responsible party type: Sponsor
mesh term: Renal Insufficiency
sharing ipd: Yes
ipd description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
ipd time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
ipd access criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
ipd url: https://astrazenecagroup-dt.pharmacm.com/DT/Home