<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/NCT03771729</url>
  </required_header>
  <id_info>
    <org_study_id>42411671-X</org_study_id>
    <nct_id>NCT03771729</nct_id>
  </id_info>
  <brief_title>Observation on the Effect of Sacubitril/Valsartan in Advanced Chronic Kidney Disease（CKD）Patients With Heart Failure</brief_title>
  <official_title>Observation on the Effect of Sacubitril/Valsartan in Advanced Chronic Kidney Disease（CKD）Patients With Heart Failure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Second Affiliated Hospital of Harbin Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Second Affiliated Hospital of Harbin Medical University</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>
      This paper will mainly present the renal results from a clinical study aimed to observe the&#xD;
      effect of sacubitril/valsartan in advanced chronic kedney disease patients with heart&#xD;
      failure.All patients will receive LCZ696.The results will be compared before and after&#xD;
      treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      On trial entry, patients will first receive LCZ696 50mg twice daily.According to the&#xD;
      condition of disease and tolerance,the dose will be doubled every 2 weeks until the target&#xD;
      maintenance dose 200mg twice daily is reached unless potassium or change in kidney function&#xD;
      preclude a dose increase(reduction in dose will be permitted if the larger dose will not be&#xD;
      tolerated, and temporary interruption will be permitted at any time if required for clinical&#xD;
      reasons).The trial will be followed up for 12 weeks. Study visits will be scheduled at&#xD;
      2,4,6,8,10and12 weeks (and additional visits will be arranged where necessary to monitor&#xD;
      participant safety).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">December 30, 2018</start_date>
  <completion_date type="Anticipated">June 15, 2019</completion_date>
  <primary_completion_date type="Anticipated">May 28, 2019</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in estimated glomerular filtration rate(eGFR)</measure>
    <time_frame>12 weeks</time_frame>
    <description>Blood samples will be collected for analysis of glomerular filtration rate(eGFR) every 2weeks .</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in urinary microalbumin/creatinine ratio(uACR)</measure>
    <time_frame>12 weeks</time_frame>
    <description>Urine samples will be collected for analysis of urinary microalbumin/creatinine ratio(uACR) every 2weeks.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Concentration of N terminal pro B type natriuretic peptide(NT-prpBNP)</measure>
    <time_frame>12 weeks</time_frame>
    <description>Blood samples will be collected for analysis of concentration of N terminal pro B type natriuretic peptide(NT-proBNP) every 2weeks.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>blood uric acid</measure>
    <time_frame>12 weeks</time_frame>
    <description>Blood samples will be collected for analysis of uric acid every 2weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of HbA1c</measure>
    <time_frame>12weeks</time_frame>
    <description>Blood samples will be collected for analysis of HbA1c every 2weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Systolic and diastolic blood pressure</measure>
    <time_frame>12 weeks</time_frame>
    <description>Systolic and diastolic blood pressure will be measured every 2weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>left ventricle eject fraction</measure>
    <time_frame>12 weeks</time_frame>
    <description>Cardiac ultrasound will be measured every 2weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concentration of postassium</measure>
    <time_frame>12 weeks</time_frame>
    <description>Blood samples will be collected for analysis of concentration of postassium every 2weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concentration of serum troponin</measure>
    <time_frame>12 weeks</time_frame>
    <description>Blood samples will be collected for analysis of concentration of serum troponin every 2weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concentration of alanine aminotransferase or aspartate aminotransferase</measure>
    <time_frame>12 weeks</time_frame>
    <description>Blood samples will be collected for analysis of concentration of alanine aminotransferase or aspartate aminotransferase every 2weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concentration of sodio</measure>
    <time_frame>12 weeks</time_frame>
    <description>Urine samples will be collected for analysis of concentration of sodion every 2weeks.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>CKD</condition>
  <arm_group>
    <arm_group_label>LCZ696 treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>LCZ696 200mg twice daily</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LCZ 696</intervention_name>
    <description>LCZ696 200mg twice daily</description>
    <arm_group_label>LCZ696 treatment</arm_group_label>
    <other_name>sacubitril/valsartan</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. patients diagnosed with Chronic kidney disease (eGFR&lt;60 ml/ min/1.73m²) and heart&#xD;
             failure&#xD;
&#xD;
          2. documented history of heart failure with associated signs or symptoms&#xD;
&#xD;
          3. New York Heart Association (NYHA) classes II-IV&#xD;
&#xD;
          4. mean sitting systolic blood pressure (msSBP) ⩾140mmHg&#xD;
&#xD;
          5. good compliance&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. isolated right heart failure owing to pulmonary disease, dyspnoea from non-cardiac&#xD;
             causes, primary valvular or myocardial diseases, or coronary or cerebrovascular&#xD;
             diseases needing revascularization within 3months of screening or during the trial&#xD;
&#xD;
          2. acute renal failure&#xD;
&#xD;
          3. systolic blood pressure lower than 100 mm Hg at screening (&lt;95 mm Hg at the&#xD;
             randomisation visit)&#xD;
&#xD;
          4. significant laboratory abnormalities at screening interfering with assessment of study&#xD;
             drug safety or efficacy(such as serum potassium&gt;5.5 or &lt;3.5mmol/L, serum&#xD;
             sodium&lt;130mmol/L or alanine aminotransferase or aspartate aminotransferase&gt;2 times the&#xD;
             upper limit of the normal range)&#xD;
&#xD;
          5. history of angioedema（drug-related or otherwise)&#xD;
&#xD;
          6. any medications that have potential for drug-drug interaction with LCZ696 will not be&#xD;
             allowed during the study 7)pregnant female&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>November 30, 2018</study_first_submitted>
  <study_first_submitted_qc>December 9, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 11, 2018</study_first_posted>
  <last_update_submitted>December 9, 2018</last_update_submitted>
  <last_update_submitted_qc>December 9, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 11, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Second Affiliated Hospital of Harbin Medical University</investigator_affiliation>
    <investigator_full_name>Xuanyi Du</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Sacubitril/Valsartan</keyword>
  <keyword>Advanced CKD Patients</keyword>
  <keyword>Heart Failure</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>
    <mesh_term>Heart Failure</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Valsartan</mesh_term>
    <mesh_term>Sacubitril and valsartan sodium hydrate drug combination</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Clinical Study Report (CSR)</ipd_description>
  </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/NCT03771729
org study id: 42411671-X
nct id: NCT03771729
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This paper will mainly present the renal results from a clinical study aimed to observe the
      effect of sacubitril/valsartan in advanced chronic kedney disease patients with heart
      failure.All patients will receive LCZ696.The results will be compared before and after
      treatment.
On trial entry, patients will first receive LCZ696 50mg twice daily.According to the
      condition of disease and tolerance,the dose will be doubled every 2 weeks until the target
      maintenance dose 200mg twice daily is reached unless potassium or change in kidney function
      preclude a dose increase(reduction in dose will be permitted if the larger dose will not be
      tolerated, and temporary interruption will be permitted at any time if required for clinical
      reasons).The trial will be followed up for 12 weeks. Study visits will be scheduled at
      2,4,6,8,10and12 weeks (and additional visits will be arranged where necessary to monitor
      participant safety).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in estimated glomerular filtration rate(eGFR)
time frame: 12 weeks
description: Blood samples will be collected for analysis of glomerular filtration rate(eGFR) every 2weeks .
measure: Change in urinary microalbumin/creatinine ratio(uACR)
time frame: 12 weeks
description: Urine samples will be collected for analysis of urinary microalbumin/creatinine ratio(uACR) every 2weeks.
measure: Concentration of N terminal pro B type natriuretic peptide(NT-prpBNP)
time frame: 12 weeks
description: Blood samples will be collected for analysis of concentration of N terminal pro B type natriuretic peptide(NT-proBNP) every 2weeks.
measure: blood uric acid
time frame: 12 weeks
description: Blood samples will be collected for analysis of uric acid every 2weeks.
measure: Rate of HbA1c
time frame: 12weeks
description: Blood samples will be collected for analysis of HbA1c every 2weeks.
measure: Systolic and diastolic blood pressure
time frame: 12 weeks
description: Systolic and diastolic blood pressure will be measured every 2weeks.
measure: left ventricle eject fraction
time frame: 12 weeks
description: Cardiac ultrasound will be measured every 2weeks.
measure: Concentration of postassium
time frame: 12 weeks
description: Blood samples will be collected for analysis of concentration of postassium every 2weeks.
measure: Concentration of serum troponin
time frame: 12 weeks
description: Blood samples will be collected for analysis of concentration of serum troponin every 2weeks.
measure: Concentration of alanine aminotransferase or aspartate aminotransferase
time frame: 12 weeks
description: Blood samples will be collected for analysis of concentration of alanine aminotransferase or aspartate aminotransferase every 2weeks.
measure: Concentration of sodio
time frame: 12 weeks
description: Urine samples will be collected for analysis of concentration of sodion every 2weeks.
arm group label: LCZ696 treatment
arm group type: Experimental
description: LCZ696 200mg twice daily
intervention type: Drug
intervention name: LCZ 696
description: LCZ696 200mg twice daily
arm group label: LCZ696 treatment
other name: sacubitril/valsartan
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: The Second Affiliated Hospital of Harbin Medical University
investigator full name: Xuanyi Du
investigator title: Principal Investigator
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic
mesh term: Heart Failure
mesh term: Valsartan
mesh term: Sacubitril and valsartan sodium hydrate drug combination
sharing ipd: Undecided
ipd description: Clinical Study Report (CSR)