<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/NCT01681303</url>
  </required_header>
  <id_info>
    <org_study_id>IWW-0004</org_study_id>
    <secondary_id>98-794A3</secondary_id>
    <nct_id>NCT01681303</nct_id>
  </id_info>
  <brief_title>Effect of An Oral Absorbent AST-120 in Late-stage Chronic Kidney Disease (CKD) Patients.</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chang Gung Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chang Gung Memorial Hospital</source>
  <brief_summary>
    <textblock>
      Recent research work has directed especial attention toward a distinct group of uremic&#xD;
      retension molecules, called &quot;protein-bound uremic toxins&quot;. The prototypes of this group of&#xD;
      uremic toxins are indoxyl sulfate and p-cresol. These uremic toxins can promote production of&#xD;
      free radical and impair antioxidant system and exerts direct toxicity on different cells and&#xD;
      organs, including mesangial, tubular, endothelial cell and osteoblasts. Accumulation of these&#xD;
      protein bound uremic toxins results in glomerular sclerosis and interstitial fibrosis of&#xD;
      kidneys of uremic rats and confer skeletal resistance to parthyroid hormone in uremic&#xD;
      patients. In hemodialysis, high serum p-cresol level is associated with higher cardiovascular&#xD;
      mortality.&#xD;
&#xD;
      AST-120 (Kremezin) is a carbonated oral absorbent extensively used in Japan and Korea. It has&#xD;
      superior adsorption ability for certain small-molecular weight organic compounds known to&#xD;
      accumulate in patients with CKD. In uremic rats and CKD patients, oral administration of&#xD;
      AST-120 decreased the elevated pretreatment levels of serum indoxyl sulfate. In Japan, it was&#xD;
      reported that AST-120 suppressed the increase in serum creatinine levels, prevented&#xD;
      proteinuria, improved uremic symptoms, and, consequently, led to the postponement of dialysis&#xD;
      therapy.&#xD;
&#xD;
      Value of AST-120 on the outcome of late-stage CKD patients is still unknown. We hypothesized&#xD;
      AST-120 through reduction of level of indoxyl sulfate and p-cresol can improved the&#xD;
      morbidity- mortality of CKD patients.&#xD;
&#xD;
      The principal aim of this prospective cohort study is to investigate the effectiveness of&#xD;
      AST-120 in incidence of dialysis and mortality of late-stage CKD patients. Determination of&#xD;
      this relationship can help to establish new therapeutic strategy in the treatment of&#xD;
      late-stage CKD patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2009</start_date>
  <completion_date type="Actual">December 2011</completion_date>
  <primary_completion_date type="Actual">September 2011</primary_completion_date>
  <phase>Phase 4</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>renal function change</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>anemia</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>lipid profile and uric acid</measure>
    <time_frame>1 year</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">51</enrollment>
  <condition>Chronic Kidney Disease</condition>
  <condition>AST-120</condition>
  <arm_group>
    <arm_group_label>AST-120 group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Administration of AST-120</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AST-120</intervention_name>
    <arm_group_label>AST-120 group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adults aged &gt; 18 year-old or &lt; 85 year-old&#xD;
&#xD;
          -  eGFR or CCR &lt; 60 ml/min&#xD;
&#xD;
          -  hemoglobin &lt; 10 g/dL, ESA-naïve, had adequate iron storage (serum ferritin &gt; 200 ng/dL&#xD;
             and transferrin saturation &gt; 20%)&#xD;
&#xD;
          -  no spontaneous renal improvement or progression in past 3 months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  renal transplant recipients, liver cirrhosis, bone marrow disorder&#xD;
&#xD;
          -  blood pressure &gt; 170/80 mmHg in 3 occasions&#xD;
&#xD;
          -  recent cardiovascular disease (Coronary artery disease, myocardial ischemia,&#xD;
             cerebrovascular disease or peripheral artery disease) or gastrointestinal bleeding in&#xD;
             past 3 months&#xD;
&#xD;
          -  acute tubular necrosis in the past 3 months&#xD;
&#xD;
          -  unwilling to participate in the trial&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>I-Wen Wu, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chang Gung Memorial Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Nephrology, Chang Gung Memorial Hospital</name>
      <address>
        <city>Keelung</city>
        <zip>204</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>August 2013</verification_date>
  <study_first_submitted>September 5, 2012</study_first_submitted>
  <study_first_submitted_qc>September 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 7, 2012</study_first_posted>
  <last_update_submitted>August 3, 2013</last_update_submitted>
  <last_update_submitted_qc>August 3, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 6, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chang Gung Memorial Hospital</investigator_affiliation>
    <investigator_full_name>iwenwu</investigator_full_name>
    <investigator_title>Attending Physician</investigator_title>
  </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/NCT01681303
org study id: IWW-0004
secondary id: 98-794A3
nct id: NCT01681303
lead sponsor: 
Recent research work has directed especial attention toward a distinct group of uremic
      retension molecules, called "protein-bound uremic toxins". The prototypes of this group of
      uremic toxins are indoxyl sulfate and p-cresol. These uremic toxins can promote production of
      free radical and impair antioxidant system and exerts direct toxicity on different cells and
      organs, including mesangial, tubular, endothelial cell and osteoblasts. Accumulation of these
      protein bound uremic toxins results in glomerular sclerosis and interstitial fibrosis of
      kidneys of uremic rats and confer skeletal resistance to parthyroid hormone in uremic
      patients. In hemodialysis, high serum p-cresol level is associated with higher cardiovascular
      mortality.

      AST-120 (Kremezin) is a carbonated oral absorbent extensively used in Japan and Korea. It has
      superior adsorption ability for certain small-molecular weight organic compounds known to
      accumulate in patients with CKD. In uremic rats and CKD patients, oral administration of
      AST-120 decreased the elevated pretreatment levels of serum indoxyl sulfate. In Japan, it was
      reported that AST-120 suppressed the increase in serum creatinine levels, prevented
      proteinuria, improved uremic symptoms, and, consequently, led to the postponement of dialysis
      therapy.

      Value of AST-120 on the outcome of late-stage CKD patients is still unknown. We hypothesized
      AST-120 through reduction of level of indoxyl sulfate and p-cresol can improved the
      morbidity- mortality of CKD patients.

      The principal aim of this prospective cohort study is to investigate the effectiveness of
      AST-120 in incidence of dialysis and mortality of late-stage CKD patients. Determination of
      this relationship can help to establish new therapeutic strategy in the treatment of
      late-stage CKD patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: renal function change
time frame: 1 year
measure: anemia
time frame: 1 year
measure: lipid profile and uric acid
time frame: 1 year
arm group label: AST-120 group
arm group type: Experimental
description: Administration of AST-120
arm group label: 2
arm group type: No Intervention
intervention type: Drug
intervention name: AST-120
arm group label: AST-120 group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: I-Wen Wu, MD
role: Principal Investigator
affiliation: Chang Gung Memorial Hospital
facility: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: Chang Gung Memorial Hospital
investigator full name: iwenwu
investigator title: Attending Physician
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic