<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/NCT02975505</url>
  </required_header>
  <id_info>
    <org_study_id>16-20978</org_study_id>
    <nct_id>NCT02975505</nct_id>
  </id_info>
  <brief_title>Pilot to Examine Risk and Feasibility of Remote Management of BP From CKD Through ESRD</brief_title>
  <acronym>PERFORMANCE</acronym>
  <official_title>Pilot to Examine Risk and Feasibility of Remote Management of BP From CKD Through ESRD</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, San Francisco</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The transition from chronic kidney disease (CKD) to end-stage renal disease ESRD is a&#xD;
      vulnerable and challenging period of time for patients and providers. Suboptimal control of&#xD;
      blood pressure is known to be common in patients with the advanced stages of CKD, and may&#xD;
      contribute to their elevated risk of progression to ESRD, cardiovascular morbidity, and&#xD;
      mortality. This proposal is a pilot randomized controlled trial designed to test whether&#xD;
      intensive blood pressure lowering is feasible and safe in patients with advanced CKD as they&#xD;
      transition to ESRD.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The transition from advanced chronic kidney disease (CKD), when estimated glomerular&#xD;
      filtration rate (eGFR) is &lt;=30 mL/min/1.73m2, to end-stage renal disease (ESRD) represents a&#xD;
      vulnerable period, when multiple physiologic and psychosocial changes occur as patients&#xD;
      prepare for either dialysis or kidney transplant. This study is a pilot randomized controlled&#xD;
      trial to test the safety and feasibility of studying strict versus usual BP control in a&#xD;
      population of patients with advanced CKD (eGFR &lt;=30 mL/min/1.73m2), including those with&#xD;
      diabetes. For this pilot study, we will randomize 120 patients with advanced CKD who have&#xD;
      elevated BP to either a home SBP target of &lt;120 mm Hg (intervention group) versus 130-140 mm&#xD;
      Hg (usual care group).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Suspended</overall_status>
  <why_stopped>
    Due to challenges in recruitment and holding visits during COVID&#xD;
  </why_stopped>
  <start_date type="Actual">February 10, 2017</start_date>
  <completion_date type="Anticipated">July 2026</completion_date>
  <primary_completion_date type="Anticipated">July 2026</primary_completion_date>
  <phase>N/A</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Hyperkalemia</measure>
    <time_frame>Months 1-12 and study end</time_frame>
    <description>Hyperkalemia: This will be defined as a non-hemolyzed potassium ≥6.0 meq/L.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Achieved Blood Pressure</measure>
    <time_frame>Months 4-12 and study end</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Falls and syncope by self-report or based on emergency room visits</measure>
    <time_frame>Months 1-12 and study end</time_frame>
    <description>Falls and syncope: This will be defined based on self-report or if either is the chief complaint for an ER visit.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>End-stage Renal Disease</measure>
    <time_frame>Month 1 to study end</time_frame>
    <description>Defined as receipt of chronic dialysis or kidney transplant</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants screened who enroll in trial</measure>
    <time_frame>Months 0-12</time_frame>
    <description>Feasibility of enrollment</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Chronic Kidney Disease</condition>
  <condition>Bloodpressure</condition>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Strict SBP Target</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Target Systolic Blood Pressure &lt;120 mm Hg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual SBP Target</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Target Systolic Blood Pressure 130-140 mm Hg</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Strict blood pressure control</intervention_name>
    <description>Systolic Blood Pressure Target &lt; 120 mm Hg (measured at home)</description>
    <arm_group_label>Strict SBP Target</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Adults ≥16 years of age who meet the eGFR eligibility criteria, which will be determined&#xD;
        based on whether participants have&#xD;
&#xD;
          1. at least two eGFR in the last three months that are &lt;=30 mL/min/1.73m2 or&#xD;
&#xD;
          2. prior diagnosis of CKD (per electronic chart review) and at least one eGFR &lt;=30&#xD;
             mL/min/1.73m2&#xD;
&#xD;
          3. history of hypertension&#xD;
&#xD;
          4. mid-arm circumference between 22-37cm (BP cuff size limitation) and be able to provide&#xD;
             consent to participate in our study.&#xD;
&#xD;
        Exclusion criteria&#xD;
&#xD;
        Those who:&#xD;
&#xD;
          -  are or are planning to become pregnant, due to inability to take multiple classes of&#xD;
             anti-hypertensive agents&#xD;
&#xD;
          -  are marginally housed, due to concerns regarding routine follow-up&#xD;
&#xD;
          -  are actively participating in a different interventional trial that may affect blood&#xD;
             pressure&#xD;
&#xD;
          -  are unwilling to consent to participate&#xD;
&#xD;
          -  institutionalized individuals or prisoners&#xD;
&#xD;
          -  are actively abusing illicit drugs or alcohol&#xD;
&#xD;
          -  have a history of poor or doubtful compliance (e.g., frequently missed appointments)&#xD;
&#xD;
          -  have office SBP &gt;170 mmHg&#xD;
&#xD;
          -  are already taking &gt;5 anti-hypertensive medications (any classes, including diuretics)&#xD;
             have cognitive impairment prohibiting participation in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Raymond Hsu, MD MAS</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Francisco</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Elaine Ku, MD MAS</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Francisco</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of California, San Francisco</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>November 22, 2016</study_first_submitted>
  <study_first_submitted_qc>November 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <last_update_submitted>July 1, 2022</last_update_submitted>
  <last_update_submitted_qc>July 1, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 6, 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>Kidney Diseases</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT02975505
org study id: 16-20978
nct id: NCT02975505
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The transition from chronic kidney disease (CKD) to end-stage renal disease ESRD is a
      vulnerable and challenging period of time for patients and providers. Suboptimal control of
      blood pressure is known to be common in patients with the advanced stages of CKD, and may
      contribute to their elevated risk of progression to ESRD, cardiovascular morbidity, and
      mortality. This proposal is a pilot randomized controlled trial designed to test whether
      intensive blood pressure lowering is feasible and safe in patients with advanced CKD as they
      transition to ESRD.
The transition from advanced chronic kidney disease (CKD), when estimated glomerular
      filtration rate (eGFR) is <=30 mL/min/1.73m2, to end-stage renal disease (ESRD) represents a
      vulnerable period, when multiple physiologic and psychosocial changes occur as patients
      prepare for either dialysis or kidney transplant. This study is a pilot randomized controlled
      trial to test the safety and feasibility of studying strict versus usual BP control in a
      population of patients with advanced CKD (eGFR <=30 mL/min/1.73m2), including those with
      diabetes. For this pilot study, we will randomize 120 patients with advanced CKD who have
      elevated BP to either a home SBP target of <120 mm Hg (intervention group) versus 130-140 mm
      Hg (usual care group).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Hyperkalemia
time frame: Months 1-12 and study end
description: Hyperkalemia: This will be defined as a non-hemolyzed potassium ≥6.0 meq/L.
measure: Achieved Blood Pressure
time frame: Months 4-12 and study end
measure: Falls and syncope by self-report or based on emergency room visits
time frame: Months 1-12 and study end
description: Falls and syncope: This will be defined based on self-report or if either is the chief complaint for an ER visit.
measure: End-stage Renal Disease
time frame: Month 1 to study end
description: Defined as receipt of chronic dialysis or kidney transplant
measure: Number of participants screened who enroll in trial
time frame: Months 0-12
description: Feasibility of enrollment
arm group label: Strict SBP Target
arm group type: Experimental
description: Target Systolic Blood Pressure <120 mm Hg
arm group label: Usual SBP Target
arm group type: No Intervention
description: Target Systolic Blood Pressure 130-140 mm Hg
intervention type: Other
intervention name: Strict blood pressure control
description: Systolic Blood Pressure Target < 120 mm Hg (measured at home)
arm group label: Strict SBP Target
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: No
last name: Raymond Hsu, MD MAS
role: Principal Investigator
affiliation: University of California, San Francisco
last name: Elaine Ku, MD MAS
role: Principal Investigator
affiliation: University of California, San Francisco
facility: 
country: United States
responsible party type: Sponsor
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic
sharing ipd: No