<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/NCT01717248</url>
  </required_header>
  <id_info>
    <org_study_id>GCS-100-CS-4001</org_study_id>
    <nct_id>NCT01717248</nct_id>
  </id_info>
  <brief_title>Safety Study of GCS-100 to Treat Chronic Kidney Disease</brief_title>
  <official_title>A Phase 1 Study of Weekly Doses of GCS-100 in Patients With Chronic Kidney Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>La Jolla Pharmaceutical Company</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>La Jolla Pharmaceutical Company</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the safety of GCS-100 as a treatment for chronic&#xD;
      kidney disease.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">June 2013</completion_date>
  <primary_completion_date type="Actual">June 2013</primary_completion_date>
  <phase>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>Evaluation of Safety</measure>
    <time_frame>Ongoing</time_frame>
    <description>Assess overall safety of rising dose of GCS-100 in CKD patients</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">29</enrollment>
  <condition>Chronic Kidney Disease</condition>
  <arm_group>
    <arm_group_label>GCS-100</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>GCS-100 will be administered once weekly by a ten minutes injection.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>GCS-100</intervention_name>
    <description>GCS-100 is a modified citrus pectin that binds to and sequesteres circulating galectin-3, a protein that has been shown to promote organ disease (fibrosis).</description>
    <arm_group_label>GCS-100</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1. Subject is capable of understanding the purpose and risks of the study and is able&#xD;
             to provide written Informed Consent.&#xD;
&#xD;
             2. Subject is male or female, aged &gt;=18 and &lt;= 75. Patients older than 75 y/o will be&#xD;
             included at the request of the investigator and at the discretion of the Medical&#xD;
             Monitor .&#xD;
&#xD;
             3. Adult patients with chronic kidney disease for longer than 12 months and stable in&#xD;
             the opinion of the investigator for the past 3 months 4. Systolic blood pressure &lt;=160&#xD;
             mm Hg and &gt;= 90 mm Hg on 2 readings. Diastolic blood pressure &lt;= 100 mm Hg and &gt;= 40&#xD;
             mm Hg on 2 readings during at least one of the screening visits.&#xD;
&#xD;
             5. Subject is willing to practice birth control. 6. Subject is willing and able to&#xD;
             comply with all protocol requirements. 7. Subject has a measureable level of&#xD;
             galectin-3 concentration in plasma at any time prior to entry.&#xD;
&#xD;
             8. Subject has a glomerular filtration rate between 15-45 mL/min/1.73 m2 determined&#xD;
             using the CKD-EPI equation (see section 3.6.1) 9. Subject's has clinical laboratory&#xD;
             values of:&#xD;
&#xD;
               1. Hemoglobin ≥9 g/dL&#xD;
&#xD;
               2. Total bilirubin ≤ 1.5 X Institutional Upper Limit of Normal (IULN)&#xD;
&#xD;
               3. AST and/or ALT ≤ 2.5 X the upper limit of normal 10. Female subjects of&#xD;
                  childbearing potential (i.e., women who have not been surgically sterilized or&#xD;
                  have not been post-menopausal for at least 1 year) and male subjects with&#xD;
                  partners of childbearing potential must agree to use medically acceptable methods&#xD;
                  of contraception throughout the study period.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subjects who have had treatment with an experimental (unlicensed) drug within 4 weeks&#xD;
             or ≤ 5 half-lives prior to treatment with GCS 100.&#xD;
&#xD;
          2. Subjects with kidney disease due to systemic lupus erythematosus (regardless of&#xD;
             whether active or in remission), any form of vasculitis (regardless of whether active&#xD;
             or in remission), IgA nephropathy, multiple myeloma, polycystic kidney disease,&#xD;
             untreated obstructed nephropathy or any other causes that in the opinion of the&#xD;
             investigator may put the subject at an increased risk&#xD;
&#xD;
          3. Subject is expected to start renal replacement therapy of any kind within 6 months&#xD;
             after enrollment&#xD;
&#xD;
          4. Subjects with previous solid organ transplant&#xD;
&#xD;
          5. Subject is undergoing treatment with immunosuppression agents except for topical&#xD;
             agents or inhaled steroids when conditions are chronic and stable.&#xD;
&#xD;
          6. Subject with know history of cancer within the past 5 years prior to enrollment&#xD;
             excluding non-melanoma skin cancer that is not being actively treated&#xD;
&#xD;
          7. Subject has a known history of human immunodeficiency virus infection, active&#xD;
             hepatitis C, active hepatitis B, or prior history of infection with hepatitis B (HBcAb&#xD;
             positive). Medical Monitor may approve if adequate hepatic function has been&#xD;
             documented for patients without evidence of cirrhosis for subjects with HCV or prior&#xD;
             history of hepatitis B, including, but not limited to liver biopsy.&#xD;
&#xD;
          8. Subject has a clinically relevant active infection and/or a serious co-morbid medical&#xD;
             condition such as recent myocardial infarction (within the last 6 months), unstable&#xD;
             angina, difficult-to-control congestive heart failure, uncontrolled hypertension,&#xD;
             difficult-to-control cardiac arrhythmias, chronic obstructive or chronic restrictive&#xD;
             pulmonary disease, and/or cirrhosis.&#xD;
&#xD;
          9. Subject had major surgery within 4 weeks prior to Study Day 1.&#xD;
&#xD;
         10. If female, subject is pregnant or breastfeeding.&#xD;
&#xD;
         11. Subject has a concomitant disease or condition, including laboratory abnormalities,&#xD;
             which in the opinion of the Investigator could interfere with the conduct of the study&#xD;
             or could put the subject at unacceptable risk.&#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>Pablo Pergola, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Renal Associaties PA, Research Division</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Geoffrey Block, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Denver Nephrologists, PC</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Bhupinder Singh, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Southwest Clinical Research Institute, LLC</affiliation>
  </overall_official>
  <overall_official>
    <last_name>George Fadda, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>California Institute of Renal Research</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Southwest Clinical Research Institute</name>
      <address>
        <city>Tempe</city>
        <state>Arizona</state>
        <zip>85284</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>California Institue of Renal Research</name>
      <address>
        <city>La Mesa</city>
        <state>California</state>
        <zip>91942</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Denver Nephrologists, PC</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80230</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Renal Associates PA / Research Division</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2013</verification_date>
  <study_first_submitted>October 26, 2012</study_first_submitted>
  <study_first_submitted_qc>October 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 30, 2012</study_first_posted>
  <last_update_submitted>June 19, 2013</last_update_submitted>
  <last_update_submitted_qc>June 19, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 20, 2013</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>
  <!-- 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/NCT01717248
org study id: GCS-100-CS-4001
nct id: NCT01717248
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the safety of GCS-100 as a treatment for chronic
      kidney disease.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Evaluation of Safety
time frame: Ongoing
description: Assess overall safety of rising dose of GCS-100 in CKD patients
arm group label: GCS-100
arm group type: Experimental
description: GCS-100 will be administered once weekly by a ten minutes injection.
intervention type: Drug
intervention name: GCS-100
description: GCS-100 is a modified citrus pectin that binds to and sequesteres circulating galectin-3, a protein that has been shown to promote organ disease (fibrosis).
arm group label: GCS-100
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Pablo Pergola, MD
role: Principal Investigator
affiliation: Renal Associaties PA, Research Division
last name: Geoffrey Block, MD
role: Principal Investigator
affiliation: Denver Nephrologists, PC
last name: Bhupinder Singh, MD
role: Principal Investigator
affiliation: Southwest Clinical Research Institute, LLC
last name: George Fadda, MD
role: Principal Investigator
affiliation: California Institute of Renal Research
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic