xml: <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/NCT06016036</url>
    </required_header>
    <id_info>
      <org_study_id>SAL0951A301</org_study_id>
      <nct_id>NCT06016036</nct_id>
    </id_info>
    <brief_title>SAL-0951 Tablets in the Treatment of Renal Anemia in Non-dialysis Chronic Kidney Disease</brief_title>
    <official_title>A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study of SAL-0951 Tablets in the Treatment of Renal Anemia in Non-dialysis Chronic Kidney Disease</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Shenzhen Salubris Pharmaceuticals Co., Ltd.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Shenzhen Salubris Pharmaceuticals 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>
        This study is a phase 3 randomized, double-blind, placebo-controlled clinical study to&#xD;
        evaluate the efficacy and safety of SAL-0951 in CKD-anemia patients in Non-dialysis,&#xD;
        comprising 8 weeks of double-blind treatment period followed by an open-label treatment&#xD;
        period, making up a total of 27 weeks.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">December 8, 2020</start_date>
    <completion_date type="Actual">February 21, 2022</completion_date>
    <primary_completion_date type="Actual">October 8, 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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Difference in mean Hb concentration levels from baseline at weeks 7-9</measure>
      <time_frame>Baseline and week 7-9</time_frame>
      <description>Change From Baseline in mean Hb concentration levels at week 7-9</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>double-blind phase：The cumulative percentage of subjects who achieved Hb response at any time from treatment to week 9</measure>
      <time_frame>Baseline to week 9</time_frame>
      <description>Change From Baseline in cumulative percentage of subjects who achieved Hb response at any time at week 9</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Double-blind phase：Proportion of subjects with average Hb level ≥100 g/L at week 7-9</measure>
      <time_frame>Week 7-9</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Double-blind phase：Proportion of average Hb concentration ≥100g/L and ≤120g/L in week 9</measure>
      <time_frame>Week 9</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Double-blind phase：By week 9, the cumulative proportion of subjects whose Hb increased by ≥10 g/L and whose Hb reached ≥100g/L</measure>
      <time_frame>Week 9</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Double-blind phase：By week 9, the cumulative proportion of Hb &gt; 130 g/L</measure>
      <time_frame>Week 9</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Double-blind phase：Proportion of subjects receiving intravenous iron at week 9</measure>
      <time_frame>Week 9</time_frame>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">216</enrollment>
    <condition>Renal Anemia in Non-dialysis Chronic Kidney Disease</condition>
    <arm_group>
      <arm_group_label>SAL-0951</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>SAL-0951</intervention_name>
      <description>SAL-0951：&#xD;
  initial phase：4mg QD for 8 weeks&#xD;
  subsequent phase：1mg、2mg、4mg、6mg、8mg QD，adjust the dose based on hemoglobin concentration level every 4 weeks</description>
      <arm_group_label>SAL-0951</arm_group_label>
      <other_name>SAL-0951 group</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>SAL-0951 placebo：&#xD;
  initial phase：4mg QD for 8 weeks&#xD;
  subsequent phase：1mg、2mg、4mg、6mg、8mg QD，adjust the dose based on hemoglobin concentration level every 4 weeks</description>
      <arm_group_label>Placebo</arm_group_label>
      <other_name>Placebo phase</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Aged 18-75 years old men and women;&#xD;
  &#xD;
            2. 40-100 kg weight;&#xD;
  &#xD;
            3. The glomerular filtration rate value calculated by CKD-EPI formula is &lt;60 mL/min/1.73&#xD;
               m^2 (stage 3, 4 or 5 of KDOQI chronic kidney disease) in non-dialyzed subjects with&#xD;
               confirmed anemia of chronic kidney disease;&#xD;
  &#xD;
            4. Ferritin &gt; 100 g/L and TSAT &gt; 20%;&#xD;
  &#xD;
            5. No treatment with ESA was received at least 8 weeks before randomization, and the&#xD;
               central laboratory hemoglobin value for the last two screening period (at least 6 days&#xD;
               interval) &gt;=80 g/L and &lt;=105 g/L, and the change of absolute value of the two visits&#xD;
               &lt;=10g/L;&#xD;
  &#xD;
            6. The investigators determined that dialysis or alternative kidney transplantation was&#xD;
               not required throughout the trial;&#xD;
  &#xD;
            7. Volunteer to participate in the trial and have an informed consent form signed.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Blood pressure control was poor after regular drug therapy for more than 4 weeks&#xD;
               before screening, SBP &gt; 160mmHg or DBP &gt; 100mmHg during screening;&#xD;
  &#xD;
            2. Patients with severe complications of hepatobiliary system (AST or ALT &gt; 2.5 ULN, TBiL&#xD;
               &gt; 1.5 ULN);&#xD;
  &#xD;
            3. Acute kidney injury occurred 12 weeks before screening;&#xD;
  &#xD;
            4. NYHA class III - IV heart failure or unstable angina;&#xD;
  &#xD;
            5. Acute myocardial infarction, transient ischemic attack, cerebral infarction or&#xD;
               pulmonary embolism, deep venous thrombosis occurred 6 months before randomization;&#xD;
  &#xD;
            6. Patients requiring ophthalmologic treatment for diabetic eye disease, diabetic macular&#xD;
               edema, or age-related macular degeneration, or patients with hypertrophic choroid or&#xD;
               retinopathy;&#xD;
  &#xD;
            7. Blood transfusion or red blood cell infusion within 3 months before screening;&#xD;
  &#xD;
            8. Subjects received protein anabolic hormone, testosterone heptanoate, or methadone&#xD;
               within 3 month before screening&#xD;
  &#xD;
            9. Severe hyperparathyroidism (iPTH&gt;=500pg/mL);&#xD;
  &#xD;
           10. Patients with HIV, HCV or Treponema pallidum antibody positive, or HBsAg positive with&#xD;
               HBV DNA&gt;=1000 U/mL;&#xD;
  &#xD;
           11. Severe active infection (active tuberculosis, fungal infection, etc.), systemic blood&#xD;
               disease (myelodysplastic syndrome, aplastic anemia), or hemolytic anemia, or&#xD;
               hemorrhagic anemia;&#xD;
  &#xD;
           12. A history of malignancy, exceptions: tumors determined to be cured or in remission for&#xD;
               5 years, skin basal cell or squamous cell carcinomas that have been radically&#xD;
               resected, or carcinomas in situ of any site;&#xD;
  &#xD;
           13. Chronic inflammatory disease other than glomerulonephritis that may affect red blood&#xD;
               cell production, such as systemic lupus erythematosus, rheumatoid arthritis, celiac&#xD;
               disease, etc.;&#xD;
  &#xD;
           14. A history of severe allergy to medications (e.g. anaphylactic shock) or allergy to&#xD;
               other HIF-PH inhibitors;&#xD;
  &#xD;
           15. A history of drug or alcohol abuse in the past two years;&#xD;
  &#xD;
           16. Participated in clinical trials of any other drug or medical device within 3 months&#xD;
               before screening, or plan to participate in any other clinical trials of drug or&#xD;
               medical device during the trial;&#xD;
  &#xD;
           17. SAL-0951 products or other HIF-PH inhibitors were used before screening;&#xD;
  &#xD;
           18. Female during pregnancy or lactation;&#xD;
  &#xD;
           19. From the time the informed consent form was sighed to the end of the study, woman of&#xD;
               childbearing age who does not agree to use effective contraception, or man whose&#xD;
               sexual partner is a woman of childbearing age (Effective methods of contraception&#xD;
               include transdermal patches, oral drugs, implantable or injectable contraceptives,&#xD;
               abstinence or birth control);&#xD;
  &#xD;
           20. Medical conditions that the investigators believe may pose a safety risk to subjects,&#xD;
               or confuse efficacy or safety evaluations, or interfere with subject participation.&#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_official>
      <last_name>Xueqing Yu, Ph.D</last_name>
      <role>Principal Investigator</role>
      <affiliation>Guangdong Provincial People's Hospital</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Guangdong Provincial People's Hospital</name>
        <address>
          <city>Guangzhou</city>
          <state>Guangdong</state>
          <zip>519041</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 23, 2023</study_first_submitted>
    <study_first_submitted_qc>August 23, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 29, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 2023</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>Anemia</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06016036
  org study id: SAL0951A301
  nct id: NCT06016036
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This study is a phase 3 randomized, double-blind, placebo-controlled clinical study to
        evaluate the efficacy and safety of SAL-0951 in CKD-anemia patients in Non-dialysis,
        comprising 8 weeks of double-blind treatment period followed by an open-label treatment
        period, making up a total of 27 weeks.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Difference in mean Hb concentration levels from baseline at weeks 7-9
  time frame: Baseline and week 7-9
  description: Change From Baseline in mean Hb concentration levels at week 7-9
  measure: double-blind phase：The cumulative percentage of subjects who achieved Hb response at any time from treatment to week 9
  time frame: Baseline to week 9
  description: Change From Baseline in cumulative percentage of subjects who achieved Hb response at any time at week 9
  measure: Double-blind phase：Proportion of subjects with average Hb level ≥100 g/L at week 7-9
  time frame: Week 7-9
  measure: Double-blind phase：Proportion of average Hb concentration ≥100g/L and ≤120g/L in week 9
  time frame: Week 9
  measure: Double-blind phase：By week 9, the cumulative proportion of subjects whose Hb increased by ≥10 g/L and whose Hb reached ≥100g/L
  time frame: Week 9
  measure: Double-blind phase：By week 9, the cumulative proportion of Hb > 130 g/L
  time frame: Week 9
  measure: Double-blind phase：Proportion of subjects receiving intravenous iron at week 9
  time frame: Week 9
  arm group label: SAL-0951
  arm group type: Experimental
  arm group label: Placebo
  arm group type: Placebo Comparator
  intervention type: Drug
  intervention name: SAL-0951
  description: SAL-0951：
  initial phase：4mg QD for 8 weeks
  subsequent phase：1mg、2mg、4mg、6mg、8mg QD，adjust the dose based on hemoglobin concentration level every 4 weeks
  arm group label: SAL-0951
  other name: SAL-0951 group
  intervention type: Drug
  intervention name: Placebo
  description: SAL-0951 placebo：
  initial phase：4mg QD for 8 weeks
  subsequent phase：1mg、2mg、4mg、6mg、8mg QD，adjust the dose based on hemoglobin concentration level every 4 weeks
  arm group label: Placebo
  other name: Placebo phase
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Xueqing Yu, Ph.D
  role: Principal Investigator
  affiliation: Guangdong Provincial People's Hospital
  facility: 
  country: China
  responsible party type: Sponsor
  mesh term: Kidney Diseases
  mesh term: Renal Insufficiency, Chronic
  mesh term: Anemia
  sharing ipd: No