<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/NCT04466969</url>
  </required_header>
  <id_info>
    <org_study_id>D9480R00030</org_study_id>
    <nct_id>NCT04466969</nct_id>
  </id_info>
  <brief_title>Assessment of Hyperkalemia's Illness and Treatment Burden in Chronic Kidney Disease and Heart Failure Patients: HK Registry Pilot Study</brief_title>
  <acronym>HKRegistrypilo</acronym>
  <official_title>Assessment of Hyperkalemia's Illness and Treatment Burden in Chronic Kidney Disease and Heart Failure Patients: HK Registry Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AstraZeneca</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
  </oversight_info>
  <brief_summary>
    <textblock>
      Overall study aim of this study is to analyse descriptive statistics of Patient-Reported&#xD;
      Outcome（PROs） which will be used in the Hyperkalemia（HK） registry study in hyperkalemia&#xD;
      patients with Chronic Kidney Disease（CKD） or Heart Failure（HF） to describe the practice&#xD;
      patterns of hyperkalemia treatment in in clinical practice. Based on these assessments, this&#xD;
      study will provide the information for the applicability of PRO measurements which will be&#xD;
      used in the Hyperkalemia registry study to the study population, i.e. CKD and/or HF patients&#xD;
      with hyperkalemia&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 31, 2020</start_date>
  <completion_date type="Actual">November 30, 2020</completion_date>
  <primary_completion_date type="Actual">November 30, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Analyse descriptive statistics of PROs</measure>
    <time_frame>4weeks</time_frame>
    <description>The primary focus of this study is to analyse descriptive statistics of PROs which will be used in the Hyperkalemia registry. Information on demographics, medical history, treatment patterns, medication compliance, and self-reported questionnaire will be collected.</description>
  </primary_outcome>
  <number_of_groups>5</number_of_groups>
  <enrollment type="Actual">146</enrollment>
  <condition>Hyperkalemia</condition>
  <arm_group>
    <arm_group_label>HF</arm_group_label>
    <description>Patients with HF with reduced Ejection Fraction (HFrEF) is enrolled if patients meet following criteria within 6 months:&#xD;
Ejection Fraction ratio（EF） ≤40%&#xD;
New York Heart Association(NYHA) class II-IV</description>
  </arm_group>
  <arm_group>
    <arm_group_label>stages of CKD (stage 3b)</arm_group_label>
    <description>CKD is diagnosed based on the following e Glomerular Filtration Rate (eGFR) categories:&#xD;
Stage 3b: 30 mL/min/1.73m2 ≤ eGFR &lt;45 mL/min/1.73m2</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stages of CKD (stage 4)</arm_group_label>
    <description>CKD is diagnosed based on the following eGFR categories:&#xD;
15 mL/min/1.73m2 ≤ eGFR &lt;30 mL/min/1.73m2</description>
  </arm_group>
  <arm_group>
    <arm_group_label>stages of CKD (stage 5)</arm_group_label>
    <description>CKD is diagnosed based on the following eGFR categories:&#xD;
eGFR &lt;15 mL/min/1.73m2</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treated by potassium binders</arm_group_label>
    <description>Patients who have been treated by Potassium Binders</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        This study will include patients with hyperkalemia treated at outpatient clinics. Eligible&#xD;
        patients will be screened through the regular visit to study sites in a consecutive manner.&#xD;
        This study will be conducted in outpatient clinics in general hospitals. 150 hyperkalemia&#xD;
        patients with CKD or HFrEF will be enrolled and assessed cross-sectionally.&#xD;
&#xD;
        After the written informed consent, subjects will be asked to complete the&#xD;
        questionnaire-based survey.&#xD;
&#xD;
        Health-Related Quality of Life (HR-QoL), compliance to treatment with potassium binders,&#xD;
        and other factors including age, sex, height, weight, smoking status, alcohol use and&#xD;
        socio-economic status will be collected through the designated questionnaires. Information&#xD;
        on disease status and on treatment patterns will be collected from physicians, and the&#xD;
        latest results of laboratory tests will be collected from medical records (within 6 months&#xD;
        before enrolment).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Outpatients aged ≥20 years&#xD;
&#xD;
          -  Hyperkalemia patients defined as meeting either of the following criteria:&#xD;
&#xD;
               1. Having a history of S-K ≥5.1 mmol/L ≥2 times within 6 months before enrolment&#xD;
&#xD;
               2. Having a history of S-K ≥5.5 mmol/L once within 6 months before enrolment&#xD;
&#xD;
               3. Currently treated by potassium binders for the treatment of hyperkalemia at&#xD;
                  enrolment&#xD;
&#xD;
          -  Having been diagnosed as CKD (≥stage 3b) or HFrEF by investigators as defined below:&#xD;
&#xD;
        CKD is diagnosed based on the guidelines of CKD issued by the Japanese Society of&#xD;
        Nephrology (JSN, 2018) as being either or both of condition 1 and 2 for ≥3 months&#xD;
&#xD;
          1. Clear sign of kidney impairment based on urinalysis, imaging, blood test, or biopsy.&#xD;
             Especially, existence of ≥0.15 g/gCr of proteinuria (≥30 mg/gCr of albuminuria) is&#xD;
             important.&#xD;
&#xD;
          2. GFR &lt;45 mL/min/1.73m2 Within the routine clinical practice, GFR is estimated by serum&#xD;
             creatinine, gender, and age using following the formulation.&#xD;
&#xD;
        eGFR creat (mL/min/1.73m2) = 194 x serum creatinine (mg/dL)-1.094 x age (years)-0.287 (for&#xD;
        female patients, x 0.739)&#xD;
&#xD;
        ≥Stage 3b CKD is diagnosed based on the following eGFR categories:&#xD;
&#xD;
          -  Stage 3b: 30 mL/min/1.73m2 ≤ eGFR &lt;45 mL/min/1.73m2&#xD;
&#xD;
          -  Stage 4: 15 mL/min/1.73m2 ≤ eGFR &lt;30 mL/min/1.73m2&#xD;
&#xD;
          -  Stage 5: eGFR &lt;15 mL/min/1.73m2&#xD;
&#xD;
        Patients with HFrEF is enrolled if patients meet following criteria within 6 months:&#xD;
&#xD;
          1. EF ≤40%&#xD;
&#xD;
          2. NYHA class II-IV&#xD;
&#xD;
               -  Provision of signed, written, and detailed informed consent&#xD;
&#xD;
               -  Signed written informed consent by themselves&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Currently on any chronic RRT (including hemodialysis or peritoneal dialysis &gt;30 days,&#xD;
             or kidney transplant) within 6 months before enrolment&#xD;
&#xD;
          -  Patients with acute kidney injury at enrolment •Patients who took blood transfusion or&#xD;
             potassium supplements within 6 months before enrolment&#xD;
&#xD;
          -  Active malignancy or life expectancy of less than 6 months.&#xD;
&#xD;
          -  Patients who have GI disturbance/chronic diarrhoea/stoma, and investigators determine&#xD;
             those affect significantly serum K level&#xD;
&#xD;
          -  Patients who have autoimmune disorders, and investigators determine those affect&#xD;
             significantly serum K level&#xD;
&#xD;
          -  Patients whose lab data have suspicion for pseudohyperkalemia&#xD;
&#xD;
          -  Patients who are pregnant, lactating, or planning to become pregnant&#xD;
&#xD;
          -  Current participation in interventional studies and/or clinical trials&#xD;
&#xD;
          -  Patients who, in the opinion of the investigators, would be unlikely to comply with&#xD;
             self-assessments&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Nagoyashi</city>
        <state>Aichi</state>
        <zip>457-8511</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Matsudoshi</city>
        <state>Chiba</state>
        <zip>271-0077</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Iizukashi</city>
        <state>Fukuoka</state>
        <zip>820-8505</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Sashimagun</city>
        <state>Ibaraki</state>
        <zip>306-0433</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Tsuchiurashi</city>
        <state>Ibaraki</state>
        <zip>300-0028</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <link>
    <url>https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;amp;parentIdentifier=D9480R00030&amp;amp;attachmentIdentifier=ca791ad0-f043-4151-ac36-d7a3e8d6023b&amp;amp;fileName=CSR_synopsis.pdf&amp;amp;versionIdentifier=</url>
    <description>CSR Synopsis</description>
  </link>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>July 7, 2020</study_first_submitted>
  <study_first_submitted_qc>July 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <last_update_submitted>September 6, 2021</last_update_submitted>
  <last_update_submitted_qc>September 6, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2021</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>Kidney Diseases</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</mesh_term>
    <mesh_term>Heart Failure</mesh_term>
    <mesh_term>Hyperkalemia</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/studies 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_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/NCT04466969
org study id: D9480R00030
nct id: NCT04466969
lead sponsor: 
is fda regulated drug: No
Overall study aim of this study is to analyse descriptive statistics of Patient-Reported
      Outcome（PROs） which will be used in the Hyperkalemia（HK） registry study in hyperkalemia
      patients with Chronic Kidney Disease（CKD） or Heart Failure（HF） to describe the practice
      patterns of hyperkalemia treatment in in clinical practice. Based on these assessments, this
      study will provide the information for the applicability of PRO measurements which will be
      used in the Hyperkalemia registry study to the study population, i.e. CKD and/or HF patients
      with hyperkalemia
observational model: Other
time perspective: Prospective
measure: Analyse descriptive statistics of PROs
time frame: 4weeks
description: The primary focus of this study is to analyse descriptive statistics of PROs which will be used in the Hyperkalemia registry. Information on demographics, medical history, treatment patterns, medication compliance, and self-reported questionnaire will be collected.
arm group label: HF
description: Patients with HF with reduced Ejection Fraction (HFrEF) is enrolled if patients meet following criteria within 6 months:
Ejection Fraction ratio（EF） ≤40%
New York Heart Association(NYHA) class II-IV
arm group label: stages of CKD (stage 3b)
description: CKD is diagnosed based on the following e Glomerular Filtration Rate (eGFR) categories:
Stage 3b: 30 mL/min/1.73m2 ≤ eGFR <45 mL/min/1.73m2
arm group label: Stages of CKD (stage 4)
description: CKD is diagnosed based on the following eGFR categories:
15 mL/min/1.73m2 ≤ eGFR <30 mL/min/1.73m2
arm group label: stages of CKD (stage 5)
description: CKD is diagnosed based on the following eGFR categories:
eGFR <15 mL/min/1.73m2
arm group label: Treated by potassium binders
description: Patients who have been treated by Potassium Binders
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
country: Japan
url: https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;parentIdentifier=D9480R00030&amp;attachmentIdentifier=ca791ad0-f043-4151-ac36-d7a3e8d6023b&amp;fileName=CSR_synopsis.pdf&amp;versionIdentifier=
description: CSR Synopsis
responsible party type: Sponsor
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic
mesh term: Heart Failure
mesh term: Hyperkalemia
sharing ipd: Yes
ipd description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials/studies 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