<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/NCT04492722</url>
  </required_header>
  <id_info>
    <org_study_id>D7551C00001</org_study_id>
    <secondary_id>2020-002263-54</secondary_id>
    <nct_id>NCT04492722</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Safety and Efficacy of AZD5718 in Participants With Proteinuric Chronic Kidney Disease</brief_title>
  <official_title>A Phase 2b Randomised, Double-Blind, Placebo-Controlled, Multi-Centre, Dose-Ranging Study of AZD5718 in Participants With Proteinuric Chronic Kidney Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Parexel</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>George Clinical Pty Ltd</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </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>
      The purpose of the study is to evaluate the dose-response efficacy, safety, and&#xD;
      pharmacokinetics (PK) of AZD5718 in participants with proteinuric chronic kidney disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will be conducted in approximately 118 study centers across 12 countries. The&#xD;
      overall study period will be around 28 weeks. Approximately 632 participants comprising of&#xD;
      67% diabetic kidney disease (DKD) and 33% non-DKD participants will be enrolled. After a&#xD;
      screening period of up to 4 weeks, the participants will be randomised in a 1:1:1:1 ratio to&#xD;
      receive one of the doses of AZD5718 and/or placebo for the first 12 weeks (Day 85 [treatment&#xD;
      period 1]), with an add-on therapy of 8 weeks of dapagliflozin for all participants from Week&#xD;
      12 to 20 (Day 85 to 141 [treatment period 2]). Only participants still taking their assigned&#xD;
      treatment from treatment period 1 will progress to treatment period 2. Any participant with&#xD;
      urine albumin to creatinine ratio (ACR) &lt; 30 mg/g at Week 12 will be excluded from treatment&#xD;
      period 2. The eligibility check to enter treatment period 2 will be done at Visit 7 (Week 12)&#xD;
      using the last available urine ACR result. The final analysis will be done after all&#xD;
      participants have completed follow-up period of up to 4 weeks. The expected total study&#xD;
      duration, including the Screening Period, for each participant will be at least 28 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2020</start_date>
  <completion_date type="Actual">September 6, 2022</completion_date>
  <primary_completion_date type="Actual">September 6, 2022</primary_completion_date>
  <phase>Phase 2</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>
    <masking_description>No member of the study team at AstraZeneca, or representative, personnel at study centres, or any CRO handling data will have access to the randomization scheme prior to unblinding for the primary analysis.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in urine ACR to Week 20</measure>
    <time_frame>Week 1 to Week 20</time_frame>
    <description>To evaluate the dose response effect of AZD5718 on urine ACR at 20 weeks</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in urine ACR to Week 12</measure>
    <time_frame>Week 1 to Week 12</time_frame>
    <description>To evaluate the dose response effect of AZD5718 on urine ACR at 12 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with adverse events and serious adverse events</measure>
    <time_frame>Screening to Week 24</time_frame>
    <description>To assess the safety and tolerability profile of AZD5718 treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in 24-hours mean systolic blood pressure to Week 12</measure>
    <time_frame>Week 1 to Week 12</time_frame>
    <description>To evaluate the effect of AZD5718 on ambulatory blood pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma concentrations of AZD5718</measure>
    <time_frame>Week 2 to Week 20</time_frame>
    <description>To assess the PK of AZD5718 after repeated oral dosing for 20 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in estimated glomerular filtration rate (eGFR) to Week 12</measure>
    <time_frame>Week 1 to Week 12</time_frame>
    <description>To assess the effect of AZD5718 on renal function</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">613</enrollment>
  <condition>Chronic Kidney Disease</condition>
  <arm_group>
    <arm_group_label>AZD5718 Dose 1 + Dapagliflozin 10 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive once daily oral dose 1 of AZD5718 for 12 weeks, thereafter add-on therapy of 10 mg dapagliflozin for 8 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AZD5718 Dose 2 + Dapagliflozin 10 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive once daily oral dose 2 of AZD5718 for 12 weeks, thereafter add-on therapy of 10 mg dapagliflozin for 8 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AZD5718 Dose 3 + Dapagliflozin 10 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive once daily oral dose 3 of AZD5718 for 12 weeks, thereafter add-on therapy of 10 mg dapagliflozin for 8 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo + Dapagliflozin 10 mg</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will receive once daily oral dose of placebo matched to AZD5718 for 12 weeks, thereafter add-on therapy of 10 mg dapagliflozin for 8 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AZD5718</intervention_name>
    <description>Participants will receive once daily oral dose of AZD5718 as per the arms they are randomised, and will continue until Week 20.</description>
    <arm_group_label>AZD5718 Dose 1 + Dapagliflozin 10 mg</arm_group_label>
    <arm_group_label>AZD5718 Dose 2 + Dapagliflozin 10 mg</arm_group_label>
    <arm_group_label>AZD5718 Dose 3 + Dapagliflozin 10 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dapagliflozin 10 mg</intervention_name>
    <description>Participants will receive once daily oral dose of 10 mg dapagliflozin for 8 weeks as an add-on therapy.</description>
    <arm_group_label>AZD5718 Dose 1 + Dapagliflozin 10 mg</arm_group_label>
    <arm_group_label>AZD5718 Dose 2 + Dapagliflozin 10 mg</arm_group_label>
    <arm_group_label>AZD5718 Dose 3 + Dapagliflozin 10 mg</arm_group_label>
    <arm_group_label>Placebo + Dapagliflozin 10 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Participants will receive once daily oral dose of placebo matched to AZD5718, and will continue until Week 20.</description>
    <arm_group_label>Placebo + Dapagliflozin 10 mg</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Capable of giving signed informed consent form.&#xD;
&#xD;
          -  Male or female adults, &gt;= 18 years of age at study entry.&#xD;
&#xD;
          -  For participants who haven't reached the age of maturity according to local&#xD;
             regulations in their country, a written informed consent should be obtained from the&#xD;
             participant and participants legally acceptable representative.&#xD;
&#xD;
          -  Body weight within 50-150 kg and body mass index within the range 18 to 45 kg/m^2.&#xD;
&#xD;
          -  Participants with proteinuric CKD defined as:&#xD;
&#xD;
               -  eGFR 20 - 75 mL/min/1.73m^2 based on Chronic Kidney Disease Epidemiology&#xD;
                  Collaboration equation at Screening Visit 1.&#xD;
&#xD;
               -  Albuminuria defined as 200 -5000 mg albumin/g creatinine based on the geometric&#xD;
                  mean of the replicated measurements using 3 sequential first morning void urine&#xD;
                  at Visit 2.&#xD;
&#xD;
               -  Participants with diagnosis of Type 2 Diabetes Mellitus (DM) [for DKD sub-group&#xD;
                  only].&#xD;
&#xD;
          -  Females of non-childbearing potential must have been surgically sterilized or be&#xD;
             postmenopausal, and all female participants must have a negative pregnancy test at&#xD;
             screening and prior to study drug administration.&#xD;
&#xD;
          -  Male participants must be surgically sterile or agree to use highly effective&#xD;
             contraceptives. Non-sterilized male participants who are sexually active with a female&#xD;
             partner of childbearing potential must use a male condom with spermicide from Day 1 to&#xD;
             3 months after the last dose of the study drug. Approved/Certified measurements in&#xD;
             Japan are as Vasectomy, tubal occlusion, intrauterine device (provided coils are&#xD;
             copper banded), levonorgestrel intrauterine system (eg, Mirena®). These measurements&#xD;
             are acceptable forms of highly effective birth control in Japan. Not&#xD;
             Approved/Certified measurements in Japan are as: Cerazette® (desogestrel) pills,&#xD;
             medroxyprogesterone injections (eg, Depo-Provera®), etonogestrel implants (eg,&#xD;
             Implanon®, Norplan®), normal and low dose combined oral pills,&#xD;
             norelgestromin/ethinylestradiol transdermal system (eg, Evra® Patch), intravaginal&#xD;
             device (eg, NuvaRing®).&#xD;
&#xD;
          -  Provision of signed and dated written Optional Genetic Research Information informed&#xD;
             consent prior to collection of samples for optional exploratory genetic research.&#xD;
&#xD;
          -  Participants should have: a) stable blood pressure (BP [BP &lt;= 150/100 mmHg at Visit 1,&#xD;
             and 3]); b)stable dose of angiotensin converting enzyme inhibitor (ACEi) or&#xD;
             angiotensin receptor blockers (ARB) for at least 4 weeks prior to Screening Visit 1;&#xD;
             c) participants who have been unable to tolerate ACEi or ARB therapy may be enrolled.&#xD;
&#xD;
          -  Participants must have been on a stable dose for at least 4 weeks prior to Screening&#xD;
             Visit 1, who have been on additional antihypertensives (including diuretics); on&#xD;
             treatment with drugs with potential to influence albuminuria eg., non-steroidal&#xD;
             anti-inflammatory drug; on renin inhibitor or an aldosterone antagonist in combination&#xD;
             with an ACEi or an ARB.&#xD;
&#xD;
          -  Participants on Sodium-glucose co-transporter-2 inhibitors (SGLT2i) or Glucagon-like&#xD;
             peptide-1 receptor agonist (GLP1-RA) treatment, the participants must have been on a&#xD;
             stable dose for at least 4 weeks prior to randomization visit.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants with recent positive hepatitis B or hepatitis C.&#xD;
&#xD;
          -  Diagnosis of polycystic kidney disease or anatomical causes of CKD.&#xD;
&#xD;
          -  Diagnosis of Type 1 DM.&#xD;
&#xD;
          -  Participants with severe hepatic impairment (Child-Pugh class C).&#xD;
&#xD;
          -  Abnormal laboratory findings at Screening Visit 1.&#xD;
&#xD;
          -  Any of the following concomitant conditions or diseases at Screening Visit 1:&#xD;
&#xD;
               1. History of QT prolongation associated with other medications that required&#xD;
                  discontinuation of that medication, and congenital long QT syndrome.&#xD;
&#xD;
               2. Acute coronary syndrome, percutaneous coronary intervention, coronary artery&#xD;
                  bypass grafting within 6 months.&#xD;
&#xD;
               3. High degree atrioventricular block II-III, sinus node dysfunction.&#xD;
&#xD;
               4. Stroke within 3 months, heart failure, and anticipated dialysis or renal&#xD;
                  transplantation within 1 year.&#xD;
&#xD;
               5. Any other condition or clinically relevant abnormal findings in physical&#xD;
                  examination, laboratory results or ECG during screening period.&#xD;
&#xD;
               6. History of substance dependence or a positive screen for drugs or alcohol abuse.&#xD;
                  Alcohol and drug screening to be completed for all participants locally with&#xD;
                  laboratory kits provided by the central laboratory.&#xD;
&#xD;
          -  Participant who had severe course of COVID-19 (extracorporeal membrane oxygenation,&#xD;
             mechanically ventilated), and/or had a confirmed case of COVID-19 within 4 weeks of&#xD;
             Screening Visit 1.&#xD;
&#xD;
          -  Ongoing use of any biologic drug and/or small molecule targeting the immune system.&#xD;
&#xD;
          -  Any serum creatinine-altering drugs within 1 month prior to Screening Visit 1.&#xD;
&#xD;
          -  Treatment with any concomitant medications known to be associated with Torsades de&#xD;
             Pointes or potent inducers/inhibitors of cytochrome P450 3A4 within 4 weeks of Visit 3&#xD;
             (Randomization).&#xD;
&#xD;
          -  Treatment with zileuton, cilastatin (dipeptidase-1 [DPEP1] inhibitor), or leukotriene&#xD;
             receptor antagonists (eg, montelukast) within 4 weeks of Screening Visit 1.&#xD;
&#xD;
          -  Treatment with simvastatin, lovastatin, and atorvastatin at doses &gt; 40 mg per day&#xD;
             within 1 month prior to Screening Visit 1.&#xD;
&#xD;
          -  Concurrent enrollment in another clinical study involving an investigational treatment&#xD;
             or drug or participation in a device study within 3 months prior to Screening Visit 1.&#xD;
&#xD;
          -  Participants with a known hypersensitivity to AZD5718 or any of the excipients of the&#xD;
             product. Participants with a known hypersensitivity to dapagliflozin or any of the&#xD;
             excipients of the product.&#xD;
&#xD;
          -  Donation of blood or significant blood loss in excess of 500 mL within 3 months prior&#xD;
             to Day 1 (or &gt; 1200 mL in the year prior to Day 1).&#xD;
&#xD;
          -  Plasma donation within 60 days prior to Day 1.&#xD;
&#xD;
          -  Involvement in the planning and/or conduct of the study (applies to both AstraZeneca&#xD;
             staff and/or staff at the study center).&#xD;
&#xD;
          -  Judgement by the Investigator that the participant should not participate in the study&#xD;
             if the participant is unlikely to comply with study procedures, restrictions, and&#xD;
             requirements.&#xD;
&#xD;
          -  For women only - currently pregnant (a negative serum pregnancy test is required at&#xD;
             Screening Visit 1 and urine pregnancy test at Day 1 [Visit 3]) or breast-feeding.&#xD;
&#xD;
          -  An employee, or close relative of an employee, of AstraZeneca, the Contract Research&#xD;
             Organisation, or the study site, regardless of the employee's role.&#xD;
&#xD;
          -  Participants who are legally institutionalized.&#xD;
&#xD;
          -  Participants working night shifts, and who cannot avoid strenuous manual labour during&#xD;
             the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>130 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hiddo J. L. Heerspink</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Clinical Pharmacy and Pharmacology University Medical Centre Groningen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Canoga Park</city>
        <state>California</state>
        <zip>91303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>La Mesa</city>
        <state>California</state>
        <zip>91942</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>San Carlos</city>
        <state>California</state>
        <zip>94070</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Victorville</city>
        <state>California</state>
        <zip>92392</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80045</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>Winter Haven</city>
        <state>Florida</state>
        <zip>33880</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Columbus</city>
        <state>Georgia</state>
        <zip>31904</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Roseville</city>
        <state>Michigan</state>
        <zip>48066</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hazelwood</city>
        <state>Missouri</state>
        <zip>63042</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Fresh Meadows</city>
        <state>New York</state>
        <zip>11365</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Great Neck</city>
        <state>New York</state>
        <zip>11021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Jamaica</city>
        <state>New York</state>
        <zip>11432</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>
    <facility>
      <name>Research Site</name>
      <address>
        <city>East Providence</city>
        <state>Rhode Island</state>
        <zip>02914</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38104-2127</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78738</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77099</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Pearland</city>
        <state>Texas</state>
        <zip>77584</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Schertz</city>
        <state>Texas</state>
        <zip>78154</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bahia Blanca</city>
        <zip>B8109</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Buenos Aires</city>
        <zip>1280</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Buenos Aires</city>
        <zip>B7600FYW</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Cordoba</city>
        <zip>5000</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Cordoba</city>
        <zip>X5016KEH</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Cordoba</city>
        <zip>X5016KET</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Junín</city>
        <zip>6000</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Belem</city>
        <zip>66073-005</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Brasilia</city>
        <zip>71625-175</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Curitiba</city>
        <zip>80215-901</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Fortaleza</city>
        <zip>60430-375</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
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      <name>Research Site</name>
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        <city>Zhytomyr</city>
        <zip>10002</zip>
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      </address>
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  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Brazil</country>
    <country>Germany</country>
    <country>Hungary</country>
    <country>Israel</country>
    <country>Japan</country>
    <country>Malaysia</country>
    <country>Poland</country>
    <country>Taiwan</country>
    <country>Ukraine</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Korea, Republic of</country>
  </removed_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>July 28, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 2020</study_first_posted>
  <last_update_submitted>October 5, 2022</last_update_submitted>
  <last_update_submitted_qc>October 5, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 6, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Nephrology</keyword>
  <keyword>Chronic kidney disease</keyword>
  <keyword>Proteinuria</keyword>
  <keyword>Diabetic kidney disease</keyword>
  <keyword>Diabetes mellitus</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dapagliflozin</mesh_term>
  </intervention_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 requests will be evaluated as per the AZ disclosure commitment:&#xD;
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_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <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>
  <pending_results>
    <submitted>September 5, 2023</submitted>
  </pending_results>
  <!-- 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/NCT04492722
org study id: D7551C00001
secondary id: 2020-002263-54
nct id: NCT04492722
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of the study is to evaluate the dose-response efficacy, safety, and
      pharmacokinetics (PK) of AZD5718 in participants with proteinuric chronic kidney disease.
The study will be conducted in approximately 118 study centers across 12 countries. The
      overall study period will be around 28 weeks. Approximately 632 participants comprising of
      67% diabetic kidney disease (DKD) and 33% non-DKD participants will be enrolled. After a
      screening period of up to 4 weeks, the participants will be randomised in a 1:1:1:1 ratio to
      receive one of the doses of AZD5718 and/or placebo for the first 12 weeks (Day 85 [treatment
      period 1]), with an add-on therapy of 8 weeks of dapagliflozin for all participants from Week
      12 to 20 (Day 85 to 141 [treatment period 2]). Only participants still taking their assigned
      treatment from treatment period 1 will progress to treatment period 2. Any participant with
      urine albumin to creatinine ratio (ACR) < 30 mg/g at Week 12 will be excluded from treatment
      period 2. The eligibility check to enter treatment period 2 will be done at Visit 7 (Week 12)
      using the last available urine ACR result. The final analysis will be done after all
      participants have completed follow-up period of up to 4 weeks. The expected total study
      duration, including the Screening Period, for each participant will be at least 28 weeks.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: No member of the study team at AstraZeneca, or representative, personnel at study centres, or any CRO handling data will have access to the randomization scheme prior to unblinding for the primary analysis.
measure: Change from baseline in urine ACR to Week 20
time frame: Week 1 to Week 20
description: To evaluate the dose response effect of AZD5718 on urine ACR at 20 weeks
measure: Change from baseline in urine ACR to Week 12
time frame: Week 1 to Week 12
description: To evaluate the dose response effect of AZD5718 on urine ACR at 12 weeks
measure: Number of participants with adverse events and serious adverse events
time frame: Screening to Week 24
description: To assess the safety and tolerability profile of AZD5718 treatment
measure: Change from baseline in 24-hours mean systolic blood pressure to Week 12
time frame: Week 1 to Week 12
description: To evaluate the effect of AZD5718 on ambulatory blood pressure
measure: Plasma concentrations of AZD5718
time frame: Week 2 to Week 20
description: To assess the PK of AZD5718 after repeated oral dosing for 20 weeks
measure: Change from baseline in estimated glomerular filtration rate (eGFR) to Week 12
time frame: Week 1 to Week 12
description: To assess the effect of AZD5718 on renal function
arm group label: AZD5718 Dose 1 + Dapagliflozin 10 mg
arm group type: Experimental
description: Participants will receive once daily oral dose 1 of AZD5718 for 12 weeks, thereafter add-on therapy of 10 mg dapagliflozin for 8 weeks.
arm group label: AZD5718 Dose 2 + Dapagliflozin 10 mg
arm group type: Experimental
description: Participants will receive once daily oral dose 2 of AZD5718 for 12 weeks, thereafter add-on therapy of 10 mg dapagliflozin for 8 weeks.
arm group label: AZD5718 Dose 3 + Dapagliflozin 10 mg
arm group type: Experimental
description: Participants will receive once daily oral dose 3 of AZD5718 for 12 weeks, thereafter add-on therapy of 10 mg dapagliflozin for 8 weeks.
arm group label: Placebo + Dapagliflozin 10 mg
arm group type: Placebo Comparator
description: Participants will receive once daily oral dose of placebo matched to AZD5718 for 12 weeks, thereafter add-on therapy of 10 mg dapagliflozin for 8 weeks.
intervention type: Drug
intervention name: AZD5718
description: Participants will receive once daily oral dose of AZD5718 as per the arms they are randomised, and will continue until Week 20.
arm group label: AZD5718 Dose 1 + Dapagliflozin 10 mg
arm group label: AZD5718 Dose 2 + Dapagliflozin 10 mg
arm group label: AZD5718 Dose 3 + Dapagliflozin 10 mg
intervention type: Drug
intervention name: Dapagliflozin 10 mg
description: Participants will receive once daily oral dose of 10 mg dapagliflozin for 8 weeks as an add-on therapy.
arm group label: AZD5718 Dose 1 + Dapagliflozin 10 mg
arm group label: AZD5718 Dose 2 + Dapagliflozin 10 mg
arm group label: AZD5718 Dose 3 + Dapagliflozin 10 mg
arm group label: Placebo + Dapagliflozin 10 mg
intervention type: Drug
intervention name: Placebo
description: Participants will receive once daily oral dose of placebo matched to AZD5718, and will continue until Week 20.
arm group label: Placebo + Dapagliflozin 10 mg
criteria: 
gender: All
minimum age: 18 Years
maximum age: 130 Years
healthy volunteers: No
last name: Hiddo J. L. Heerspink
role: Principal Investigator
affiliation: Department of Clinical Pharmacy and Pharmacology University Medical Centre Groningen
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country: Argentina
country: Brazil
country: Germany
country: Hungary
country: Israel
country: Japan
country: Malaysia
country: Poland
country: Taiwan
country: Ukraine
country: United States
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic
mesh term: Dapagliflozin
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 requests 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 info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
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
submitted: September 5, 2023