<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/NCT04456803</url>
  </required_header>
  <id_info>
    <org_study_id>CTS-CO-1642</org_study_id>
    <nct_id>NCT04456803</nct_id>
  </id_info>
  <brief_title>Ferric Citrate for the Treatment of Hyperphosphatemia in Patients With Chronic Kidney Disease Undergoing Hemodialysis</brief_title>
  <official_title>A Study to Evaluate the Efficacy and Safety of Ferric Citrate Tablet for the Treatment of Hyperphosphatemia in Patients With Chronic Kidney Disease Undergoing Hemodialysis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sinomune Pharmaceutical Co., Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sinomune Pharmaceutical Co., Ltd</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the efficacy and safety of ferric citrate tablet in the control of serum&#xD;
      phosphorus levels in patients with chronic kidney disease undergoing hemodialysis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a multicenter, randomized, open-label, parallel, phase III study. This study is&#xD;
      consisting of a Screening/Washout period (14 days) and a Treatment/Observation period (12&#xD;
      weeks). The subjects with regular hemodialysis should stop using the phosphorus binder before&#xD;
      the Washout period. During the Treatment period, the subjects will be randomly assigned to&#xD;
      the ferric citrate tablets group (study group) or sevelamer carbonate tablet group (control&#xD;
      group) in the ratio of 1:1.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 24, 2019</start_date>
  <completion_date type="Anticipated">July 2021</completion_date>
  <primary_completion_date type="Anticipated">March 2021</primary_completion_date>
  <phase>Phase 3</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The change in serum phosphorus levels</measure>
    <time_frame>12 Weeks</time_frame>
    <description>The change in serum phosphorus levels at the end of treatment as compared to baseline (before the first dose).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in serum phosphorus levels</measure>
    <time_frame>week 2, 4, 6, 8</time_frame>
    <description>Changes in serum phosphorus levels from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the curve of serum phosphorus level</measure>
    <time_frame>week 0, 2, 4, 6, 8, 12</time_frame>
    <description>Area under the curve of serum phosphorus level to visit time (AUC 0-12 weeks)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The proportion of subjects whose serum phosphorus levels reached the target</measure>
    <time_frame>week 4, 6, 8 and 12</time_frame>
    <description>The proportion of subjects whose serum phosphorus levels reached the target range at week 4, 6, 8 and 12 of treatment (the standard was defined as blood phosphorus ≤1.78mmol /L, and ≥1.13mmol /L).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The change in serum calcium (corrected) levels.</measure>
    <time_frame>week 4, 8 and 12</time_frame>
    <description>The change in serum calcium (corrected) levels at week 4, 8 and 12 of treatment as compared to baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The change in the level of intact-PTH levels.</measure>
    <time_frame>week 4, 8 and 12</time_frame>
    <description>The change in the level of intact-PTH levels at week 4, 8 and 12 of treatment as compared to baseline.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">240</enrollment>
  <condition>Hyperphosphatemia</condition>
  <condition>End Stage Renal Disease</condition>
  <condition>ESRD</condition>
  <arm_group>
    <arm_group_label>Ferric citrate tablet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ferric citrate arm will receive ferric citrate tablets three times a day with each meal.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sevelamer carbonate tablet</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Sevelamer carbonate arm will receive sevelamer carbonate tablets three times a day with each meal.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ferric citrate tablet</intervention_name>
    <description>250mg/tablet, manufactured by Sinomune Pharmaceutical</description>
    <arm_group_label>Ferric citrate tablet</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sevelamer carbonate tablet</intervention_name>
    <description>800 mg/tablet, manufactured by Genzyme Ireland Limited</description>
    <arm_group_label>Sevelamer carbonate tablet</arm_group_label>
    <other_name>Renvela</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Between the age of 18 and 75 years (including the boundary value) and no gender&#xD;
             limitation;&#xD;
&#xD;
          2. Patients who maintain the hemodialysis schedule (including hemofiltration (HF)&#xD;
             hemodialysis (HDF) hemoperfusion (HP)) as not less than 3 times a week in the 3 months&#xD;
             before random enrollment.&#xD;
&#xD;
          3. Patients with a serum phosphorus level between 1.97 to 3.23 mmol/L (excluding the&#xD;
             boundary value) after washout.&#xD;
&#xD;
          4. Kt/Vurea ≥1.2 or URR ≥65%.&#xD;
&#xD;
          5. Before the screening period, CKD-MBD related drug treatment is stable for more than&#xD;
             one month, including the use of vitamin D (active vitamin D, vitamin D analogues,&#xD;
             etc.) or calcimimetics (cinacalcet, etc.) and the dose remains unchanged.&#xD;
&#xD;
          6. The expected survival is greater than 6 months.&#xD;
&#xD;
          7. Willing to give written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with a serum ferritin level ≥800 ng/mL or TSAT ≥50%.&#xD;
&#xD;
          2. Patients with hemochromatosis or patients receiving treatment for iron overload, or&#xD;
             patients with paroxysmal sleep hemoglobinuria.&#xD;
&#xD;
          3. Patients who received blood transfusions within 3 months prior to Screening, or&#xD;
             patients with hemoglobin ≤60 g/L.&#xD;
&#xD;
          4. Patients with intact-PTH &gt;1000 pg/mL&#xD;
&#xD;
          5. Patients complicated with any of the following gastrointestinal diseases: acute peptic&#xD;
             ulcer, chronic ulcerative colitis, localized enteritis, intestinal obstruction,&#xD;
             habitual constipation (number of stools once per week), and chronic diarrhea (number&#xD;
             of stools four times per day), or patients with a history of gastrectomy or&#xD;
             enterectomy or patients who had undergone gastrointestinal surgery within 3 months&#xD;
             prior to Screening, or patients with dysphagia.&#xD;
&#xD;
          6. Patients with impaired liver function (hepatic dysfunction or serum total bilirubin,&#xD;
             aspartate aminotransferase or alanine aminotransferase ≥ 2 times the upper limit of&#xD;
             normal) or patients with cirrhosis.&#xD;
&#xD;
          7. Patients with a history of parathyroidectomy (PTx) or percutaneous anhydrous ethanol&#xD;
             injection (PEIT) within 6 months.&#xD;
&#xD;
          8. Patients with uncontrolled diabetes or uncontrolled high blood pressure or current&#xD;
             active infectious diseases such as active viral hepatitis.&#xD;
&#xD;
          9. Patients with a history of severe allergies may be allergic to research drugs.&#xD;
&#xD;
         10. Patients with cerebrovascular disease (cerebral infarction, cerebral hemorrhage, etc.)&#xD;
             or cardiovascular disease (congestive heart failure of Class III or severer in NYHA&#xD;
             classification) requiring hospitalization within 6 months prior to Screening, or&#xD;
             patients who use antiarrhythmic drugs to control arrhythmias or who use antiepileptic&#xD;
             drugs to control seizures.&#xD;
&#xD;
         11. Patients who plan to receive a kidney transplant during the study period.&#xD;
&#xD;
         12. Patients with a history of drug and alcohol abuse&#xD;
&#xD;
         13. Patients with active or advanced malignancy.&#xD;
&#xD;
         14. Women who are pregnant or lactating&#xD;
&#xD;
         15. Patients complicated with active bleeding or requiring anticoagulation therapy with&#xD;
             citrate in hemodialysis&#xD;
&#xD;
         16. Patients who had participated in other clinical studies within 1 month prior to&#xD;
             Screening.&#xD;
&#xD;
         17. Patients who are not suitable for participating in the trial according to the&#xD;
             investigator's judgment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Sinomune Pharma</last_name>
    <phone>+86 18101967192</phone>
    <email>zxh@sinomune.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Sinomune Pharma</last_name>
    <phone>+86 15951141363</phone>
    <email>huanglu@sinomune.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>The first affiliated hospital of Baotou medical college</name>
      <address>
        <city>Baotou</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Caili Wang</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Beijing Tongren Hospital</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Guojuan Zhang</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Peking Union Medical College Hospital</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xuemei Li</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Second Xiangya Hospital of Central South University</name>
      <address>
        <city>Changsha</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hong Liu</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Xiangya Hospital Central South University</name>
      <address>
        <city>Changsha</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xiangcheng Xiao</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The second hospital of Dalian medical university</name>
      <address>
        <city>Dalian</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Feng Zheng</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The affiliated hospital of Inner Mongolia Medical University</name>
      <address>
        <city>Hohhot</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jianrong Zhao</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The second people's hospital of Huaian</name>
      <address>
        <city>Huai'an</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Donghui Zheng</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Jinan central hospital</name>
      <address>
        <city>Jinan</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xiaoping Wang</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Shandong province Qianfoshan hospital</name>
      <address>
        <city>Jinan</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zunsong Wang</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Zhongnan Hospital Southeast University</name>
      <address>
        <city>Nanjing</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bicheng Liu</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The people's hospital of Guangxi Zhuang Autonomous Region</name>
      <address>
        <city>Nanning</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kun Ye</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Shenzhen people's hospital</name>
      <address>
        <city>Shenzhen</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xinzhou Zhang</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The third hospital of Hebei medical university</name>
      <address>
        <city>Shijiazhuang</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ying Li</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>General Hospital of Tianjin Medical University</name>
      <address>
        <city>Tianjin</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tiekun Yan</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>First Affiliated Hospital of Zhengzhou University</name>
      <address>
        <city>Zhengzhou</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pei Wang</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Henan provincal people's hospital</name>
      <address>
        <city>Zhengzhou</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Qing Zhu</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Zhengzhou People's Hospital</name>
      <address>
        <city>Zhengzhou</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Li Xing</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Zhuzhou Central Hospital</name>
      <address>
        <city>Zhuzhou</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xiumei Hu</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Xinjiang Medical University</name>
      <address>
        <city>Ürümqi</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Suhua Li</last_name>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 30, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>June 30, 2020</last_update_submitted>
  <last_update_submitted_qc>June 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2020</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>Kidney Failure, Chronic</mesh_term>
    <mesh_term>Hyperphosphatemia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sevelamer</mesh_term>
  </intervention_browse>
  <!-- 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/NCT04456803
org study id: CTS-CO-1642
nct id: NCT04456803
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To evaluate the efficacy and safety of ferric citrate tablet in the control of serum
      phosphorus levels in patients with chronic kidney disease undergoing hemodialysis.
This is a multicenter, randomized, open-label, parallel, phase III study. This study is
      consisting of a Screening/Washout period (14 days) and a Treatment/Observation period (12
      weeks). The subjects with regular hemodialysis should stop using the phosphorus binder before
      the Washout period. During the Treatment period, the subjects will be randomly assigned to
      the ferric citrate tablets group (study group) or sevelamer carbonate tablet group (control
      group) in the ratio of 1:1.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The change in serum phosphorus levels
time frame: 12 Weeks
description: The change in serum phosphorus levels at the end of treatment as compared to baseline (before the first dose).
measure: Changes in serum phosphorus levels
time frame: week 2, 4, 6, 8
description: Changes in serum phosphorus levels from baseline
measure: Area under the curve of serum phosphorus level
time frame: week 0, 2, 4, 6, 8, 12
description: Area under the curve of serum phosphorus level to visit time (AUC 0-12 weeks)
measure: The proportion of subjects whose serum phosphorus levels reached the target
time frame: week 4, 6, 8 and 12
description: The proportion of subjects whose serum phosphorus levels reached the target range at week 4, 6, 8 and 12 of treatment (the standard was defined as blood phosphorus ≤1.78mmol /L, and ≥1.13mmol /L).
measure: The change in serum calcium (corrected) levels.
time frame: week 4, 8 and 12
description: The change in serum calcium (corrected) levels at week 4, 8 and 12 of treatment as compared to baseline.
measure: The change in the level of intact-PTH levels.
time frame: week 4, 8 and 12
description: The change in the level of intact-PTH levels at week 4, 8 and 12 of treatment as compared to baseline.
arm group label: Ferric citrate tablet
arm group type: Experimental
description: Ferric citrate arm will receive ferric citrate tablets three times a day with each meal.
arm group label: Sevelamer carbonate tablet
arm group type: Active Comparator
description: Sevelamer carbonate arm will receive sevelamer carbonate tablets three times a day with each meal.
intervention type: Drug
intervention name: Ferric citrate tablet
description: 250mg/tablet, manufactured by Sinomune Pharmaceutical
arm group label: Ferric citrate tablet
intervention type: Drug
intervention name: Sevelamer carbonate tablet
description: 800 mg/tablet, manufactured by Genzyme Ireland Limited
arm group label: Sevelamer carbonate tablet
other name: Renvela
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Sinomune Pharma
phone: +86 18101967192
email: zxh@sinomune.com
last name: Sinomune Pharma
phone: +86 15951141363
email: huanglu@sinomune.com
facility: 
status: Recruiting
contact: 
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status: Recruiting
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status: Recruiting
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country: China
responsible party type: Sponsor
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic
mesh term: Kidney Failure, Chronic
mesh term: Hyperphosphatemia
mesh term: Sevelamer