<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/NCT04440696</url>
  </required_header>
  <id_info>
    <org_study_id>JBL-2019-001</org_study_id>
    <nct_id>NCT04440696</nct_id>
  </id_info>
  <brief_title>To Evaluate the Patient Tolerance, Pharmacodynamics and Pharmacokinetics of Lanthanum Polystyrene Sulfonate Powder</brief_title>
  <official_title>To Evaluate the Tolerance, pd, and pk of Lanthanum Polystyrene-sulfonate Powder in a Phase Ib/ IIa Clinical Trial in Patients With ESRD-HD Hyperphosphatemia With Multi-center, Multi-dose, Give the Drug Multiple Time</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Grand Life Science (Liaoning) Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The First Hospital of Jilin University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Grand Life Science (Liaoning) Co., Ltd.</source>
  <oversight_info>
    <has_dmc>No</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 aim of the study is:&#xD;
&#xD;
      To evaluate the tolerance of lanthanum polystyrene sulfonate powder in patients with&#xD;
      end-stage renal disease (ESRD-HD) hyperphosphatemia with multiple doses and multiple doses；&#xD;
      To evaluate the pharmacodynamics of lanthanum polystyrene sulfonate powder in&#xD;
      hyperphosphatemia patients with end-stage renal disease on hemodialysis (ESRD-HD); To&#xD;
      evaluate the pharmacokinetics of lanthanum polystyrene sulfonate powder in patients with&#xD;
      end-stage renal disease (ESRD-HD) hyperphosphatemia after multi-dose and multiple&#xD;
      administration.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 21, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2022</primary_completion_date>
  <phase>Phase 1/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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Blood phosphate concentrations</measure>
    <time_frame>At pre-defined intervals from initial dose through final study visit（Day -1 to Day 17）</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma lanthanum concentrations</measure>
    <time_frame>At pre-defined intervals from initial dose through final study visit（Day -1 to Day 17）</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>24h Urinary phosphate concentrations</measure>
    <time_frame>At pre-defined intervals from initial dose through final study visit（Day 1 to Day 13）</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma PTH concentrations</measure>
    <time_frame>At pre-defined intervals from initial dose through final study visit（Day 1 to Day 17）</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma calcium concentrations</measure>
    <time_frame>At pre-defined intervals from initial dose through final study visit（Day 1 to Day 17）</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">48</enrollment>
  <condition>Hyperphosphatemia</condition>
  <arm_group>
    <arm_group_label>group 1:dose 1.5g</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>There were 12 subjects in the group, 8 of whom took lanthanum polystyrene sulfonate powder, 2 took placebo, and 2 took positive control drug （lanthanum carbonate）</description>
  </arm_group>
  <arm_group>
    <arm_group_label>group 2:dose 3g</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>There were 12 subjects in the group, 8 of whom took lanthanum polystyrene sulfonate powder, 2 took placebo, and 2 took positive control drug （lanthanum carbonate）</description>
  </arm_group>
  <arm_group>
    <arm_group_label>group 3:dose 4.5g</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>There were 12 subjects in the group, 8 of whom took lanthanum polystyrene sulfonate powder, 2 took placebo, and 2 took positive control drug （lanthanum carbonate）</description>
  </arm_group>
  <arm_group>
    <arm_group_label>group 4:dose 6g</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>There were 12 subjects in the group, 8 of whom took lanthanum polystyrene sulfonate powder, 2 took placebo, and 2 took positive control drug （lanthanum carbonate）</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lanthanum Polystyrene Sulphonate Powder</intervention_name>
    <description>D1 was administered once; D2-D12 was administered three times a day; D13 was administered once；</description>
    <arm_group_label>group 1:dose 1.5g</arm_group_label>
    <arm_group_label>group 2:dose 3g</arm_group_label>
    <arm_group_label>group 3:dose 4.5g</arm_group_label>
    <arm_group_label>group 4:dose 6g</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lanthanum Carbonate 500 MG</intervention_name>
    <description>D1 was administered once; D2-D12 was administered three times a day; D13 was administered once；</description>
    <arm_group_label>group 1:dose 1.5g</arm_group_label>
    <arm_group_label>group 2:dose 3g</arm_group_label>
    <arm_group_label>group 3:dose 4.5g</arm_group_label>
    <arm_group_label>group 4:dose 6g</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>D1 was administered once; D2-D12 was administered three times a day; D13 was administered once；</description>
    <arm_group_label>group 1:dose 1.5g</arm_group_label>
    <arm_group_label>group 2:dose 3g</arm_group_label>
    <arm_group_label>group 3:dose 4.5g</arm_group_label>
    <arm_group_label>group 4:dose 6g</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria(Only if all the criteria are met):&#xD;
&#xD;
          -  1) Sign the informed consent before the trial, and fully understand the test content,&#xD;
             process and possible adverse reactions;&#xD;
&#xD;
          -  2) Able to complete the study according to the requirements of the experimental&#xD;
             program, able to accept dietary management and unified diet during the trial;&#xD;
&#xD;
          -  3) Regular hemodialysis was performed three times a week in the 12 weeks before&#xD;
             screening (the total number of weeks without three times a week for special reasons&#xD;
             should not exceed 2 weeks), and the dialysis regimen was expected to remain unchanged&#xD;
             during the trial;&#xD;
&#xD;
          -  4) The patient is receiving appropriate dialysis treatment, and the urea clearance&#xD;
             index (KT /V) ≥1.2 (the KT /V value of the research center within one month before&#xD;
             screening is valid, and the results of several measurements shall be subject to the&#xD;
             latest measurement);&#xD;
&#xD;
          -  5) Subjects (including partners) are willing to voluntarily use effective&#xD;
             contraceptive measures within 6 months from the screening to the last study drug&#xD;
             administration, as detailed contraceptive measures are shown in Appendix 4;&#xD;
&#xD;
          -  6) Male and female subjects aged 18 to 65 years (including 18 and 65 years) with a&#xD;
             body mass index (BMI) in the range of 18 to 35 kg/m2 (including the threshold);&#xD;
&#xD;
          -  7) In patients with end-stage renal disease hyperphosphatemia, fasting blood&#xD;
             phosphorus ≥1.78mmol/L and ≤3.23mmol/L were measured at screening and admission.&#xD;
&#xD;
        Exclusion Criteria(If one of the exclusion criteria is satisfied, it is excluded):&#xD;
&#xD;
          -  1) A history of clinically significant drug allergy or atopic allergic disease&#xD;
             (asthma, urticaria, eczema dermatitis) or known allergy to the experimental drug or&#xD;
             similar drug;&#xD;
&#xD;
          -  2) Patients who had severe trauma or had undergone major surgery within 6 months prior&#xD;
             to the trial, or who planned to undergo surgery during the study period were screened;&#xD;
&#xD;
          -  3) Blood loss &gt; 450mL in the three months before screening;&#xD;
&#xD;
          -  4) Clinical, radiological or laboratory evidence of active tuberculosis (TB);&#xD;
&#xD;
          -  5) Previous kidney transplantation operations;&#xD;
&#xD;
          -  6) A history of drug use and/or alcohol abuse in the 3 months prior to screening (14&#xD;
             units of alcohol consumed per week: 1 unit = 285 mL beer, 25 mL spirits, or 100 mL&#xD;
             wine);&#xD;
&#xD;
          -  7) Those who were receiving any vitamin D or calcium-like regimens at the time of&#xD;
             screening and could not maintain a stable dose after admission (except those who were&#xD;
             receiving a stable vitamin D or calcium-like regimens);&#xD;
&#xD;
          -  8) Have dysphagia or gastrointestinal history with any influence on drug absorption,&#xD;
             including but not limited to intestinal obstruction, macrocolon, habitual constipation&#xD;
             (stool frequency &lt; 1 times per week), chronic diarrhea (stool frequency ≥4 times per&#xD;
             day), gastroparesis with nausea or vomiting and other gastrointestinal disorders and&#xD;
             gastrointestinal surgery;&#xD;
&#xD;
          -  9) suffer from any disease that increases the risk of gastrointestinal bleeding, such&#xD;
             as acute erosive gastritis, acute hemorrhagic necrotizing enteritis, or active&#xD;
             gastrointestinal ulcer;&#xD;
&#xD;
          -  10) For poorly controlled hypertension, the systolic blood pressure ≥180 mmHg and/or&#xD;
             diastolic blood pressure ≥110 mmHg should be measured at rest, and the patient should&#xD;
             be rechecked at most twice for confirmation;&#xD;
&#xD;
          -  11) The history of acute coronary syndrome (such as myocardial infarction, unstable&#xD;
             angina pectoris hospitalization), or percutaneous coronary intervention, or coronary&#xD;
             artery bypass grafting in the previous 12 months was screened;Or had an&#xD;
             arterial/venous thrombosis event, such as a cerebrovascular accident (including a&#xD;
             history of stroke or transient ischemic attack), deep venous thrombosis and pulmonary&#xD;
             embolism, within 12 months before screening;&#xD;
&#xD;
          -  12) Uncontrolled severe arrhythmias, such as recurrent and highly symptomatic&#xD;
             ventricular tachycardia, atrial fibrillation with rapid ventricular response, or&#xD;
             supraventricular tachycardia, that were not controlled by medication or other&#xD;
             treatment in the 12 months prior to enrolment;&#xD;
&#xD;
          -  13) Unstable and serious diseases of the digestive system, respiratory system, mental&#xD;
             nervous system, endocrine system, blood system, malignant tumor, etc., which are not&#xD;
             suitable for the study as judged by the study doctor;&#xD;
&#xD;
          -  14) Screening patients with a history of acute or severe infection within the previous&#xD;
             1 month;&#xD;
&#xD;
          -  15) Take phosphorus-reducing drugs, such as lanthanum carbonate, calcium carbonate,&#xD;
             calcium acetate, aluminum hydroxide, Sveram, etc., within 14 days before&#xD;
             administration;Drugs that may affect lanthanum ion release, such as proton pump&#xD;
             inhibitors, H2 receptor antagonists, etc.And drugs that interact with experimental&#xD;
             drugs, such as ciprofloxacin hydrochloride, thyroxine, lithium, etc.;Drugs containing&#xD;
             phosphoric acid components, such as oseltamivir phosphate, sitagliptin phosphate&#xD;
             tablets, etc.&#xD;
&#xD;
          -  16) Those who have participated in any clinical trials of drugs or medical devices&#xD;
             within one month before taking the study drug;&#xD;
&#xD;
          -  17) During screening, hemoglobin ≤90g/L and albumin ≤30g/L;&#xD;
&#xD;
          -  18) Hypercalcemia, blood calcium ≥2.52mmol/L;Hypocalcemia, blood calcium ≤1.80mmol/L&#xD;
             (corrected blood calcium value: corrected blood calcium value mmol/L= measured calcium&#xD;
             value mmol/L+0.02× (40g/L- measured serum albumin value g/L));&#xD;
&#xD;
          -  19) Severe hyperparathyroidism, parathyroid hormone (PTH) &gt;1200pg/mL;&#xD;
&#xD;
          -  20) Female subjects with positive blood pregnancy results during the screening period&#xD;
             or baseline period;&#xD;
&#xD;
          -  21) HIV antigen/antibody positive;Positive antibody to Treponema pallidum and positive&#xD;
             serological test of non-Treponema pallidum (such as rapid plasma reaction test,&#xD;
             toluidine red unheated serum test, etc.);&#xD;
&#xD;
          -  22) A history of heart failure as defined by the New York College of Cardiology (NYHA)&#xD;
             as III-IV, or a left ventricular ejection fraction less than 40%;&#xD;
&#xD;
          -  23) Subjects who have other factors considered by the investigator to be unsuitable&#xD;
             for participating in this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yanhua Ding, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>The First Hospital of Jilin University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Xiaoyan Wen, MA</last_name>
    <phone>+86 18704019565</phone>
    <email>wenxiaoyan@nkbp.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>The First Hospital of Jilin University</name>
      <address>
        <city>Changchun</city>
        <state>Jilin</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yanhua Ding</last_name>
      <phone>18186879468</phone>
      <email>dingyanhua2003@126.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>June 16, 2020</study_first_submitted>
  <study_first_submitted_qc>June 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <last_update_submitted>July 27, 2021</last_update_submitted>
  <last_update_submitted_qc>July 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 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>Hyperphosphatemia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Polystyrene sulfonic acid</mesh_term>
  </intervention_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/NCT04440696
org study id: JBL-2019-001
nct id: NCT04440696
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of the study is:

      To evaluate the tolerance of lanthanum polystyrene sulfonate powder in patients with
      end-stage renal disease (ESRD-HD) hyperphosphatemia with multiple doses and multiple doses；
      To evaluate the pharmacodynamics of lanthanum polystyrene sulfonate powder in
      hyperphosphatemia patients with end-stage renal disease on hemodialysis (ESRD-HD); To
      evaluate the pharmacokinetics of lanthanum polystyrene sulfonate powder in patients with
      end-stage renal disease (ESRD-HD) hyperphosphatemia after multi-dose and multiple
      administration.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Blood phosphate concentrations
time frame: At pre-defined intervals from initial dose through final study visit（Day -1 to Day 17）
measure: Plasma lanthanum concentrations
time frame: At pre-defined intervals from initial dose through final study visit（Day -1 to Day 17）
measure: 24h Urinary phosphate concentrations
time frame: At pre-defined intervals from initial dose through final study visit（Day 1 to Day 13）
measure: Plasma PTH concentrations
time frame: At pre-defined intervals from initial dose through final study visit（Day 1 to Day 17）
measure: Plasma calcium concentrations
time frame: At pre-defined intervals from initial dose through final study visit（Day 1 to Day 17）
arm group label: group 1:dose 1.5g
arm group type: Experimental
description: There were 12 subjects in the group, 8 of whom took lanthanum polystyrene sulfonate powder, 2 took placebo, and 2 took positive control drug （lanthanum carbonate）
arm group label: group 2:dose 3g
arm group type: Experimental
description: There were 12 subjects in the group, 8 of whom took lanthanum polystyrene sulfonate powder, 2 took placebo, and 2 took positive control drug （lanthanum carbonate）
arm group label: group 3:dose 4.5g
arm group type: Experimental
description: There were 12 subjects in the group, 8 of whom took lanthanum polystyrene sulfonate powder, 2 took placebo, and 2 took positive control drug （lanthanum carbonate）
arm group label: group 4:dose 6g
arm group type: Experimental
description: There were 12 subjects in the group, 8 of whom took lanthanum polystyrene sulfonate powder, 2 took placebo, and 2 took positive control drug （lanthanum carbonate）
intervention type: Drug
intervention name: Lanthanum Polystyrene Sulphonate Powder
description: D1 was administered once; D2-D12 was administered three times a day; D13 was administered once；
arm group label: group 1:dose 1.5g
arm group label: group 2:dose 3g
arm group label: group 3:dose 4.5g
arm group label: group 4:dose 6g
intervention type: Drug
intervention name: Lanthanum Carbonate 500 MG
description: D1 was administered once; D2-D12 was administered three times a day; D13 was administered once；
arm group label: group 1:dose 1.5g
arm group label: group 2:dose 3g
arm group label: group 3:dose 4.5g
arm group label: group 4:dose 6g
intervention type: Drug
intervention name: Placebo
description: D1 was administered once; D2-D12 was administered three times a day; D13 was administered once；
arm group label: group 1:dose 1.5g
arm group label: group 2:dose 3g
arm group label: group 3:dose 4.5g
arm group label: group 4:dose 6g
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Yanhua Ding, Ph.D
role: Principal Investigator
affiliation: The First Hospital of Jilin University
last name: Xiaoyan Wen, MA
phone: +86 18704019565
email: wenxiaoyan@nkbp.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Hyperphosphatemia
mesh term: Polystyrene sulfonic acid
sharing ipd: No