<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/NCT03759158</url>
  </required_header>
  <id_info>
    <org_study_id>ILBS-Cirrhosis-19</org_study_id>
    <nct_id>NCT03759158</nct_id>
  </id_info>
  <brief_title>N-Acetyl Cysteine in the Prevention of Contrast Induced Nephropathy in Cirrhosis of Liver-NEPHRO Trial</brief_title>
  <official_title>N-Acetyl Cysteine in the Prevention of Contrast Induced Nephropathy in Cirrhosis of Liver-NEPHRO Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institute of Liver and Biliary Sciences, India</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institute of Liver and Biliary Sciences, India</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>
      Contrast induced nephropathy has an incidence of 7-11 % in patients undergoing Contrast&#xD;
      imaging for various conditions. The risk associated with the development of CIN are still&#xD;
      under evaluation. Even with patients having normal kidney functions there is a risk of&#xD;
      contrast induced nephropathy hence the need for markers which could predict injury. Cirrhosis&#xD;
      of liver predisposes patient to Kidney abnormalities as these patients lower renal reserve&#xD;
      and can have various conditions like Hepatorenal syndrome, Sepsis, ATN. Contrast imaging is&#xD;
      vital for ruling out conditions like Hepatocellular Carcinoma in patients of cirrhosis of&#xD;
      liver. Presently there is no study in cirrhosis of liver which studies the Effect of N-acetyl&#xD;
      cysteine before and after contrast imaging in the prevention Of CIN. The incidence of CNI is&#xD;
      cirrhosis is also an avenue which requires more studies and also there is a need for&#xD;
      formulation of a Score to predict this CIN. Hence this study is being done to assess the&#xD;
      incidence of CNI and the role of N-Acetyl cysteine in Preventing CNI.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2018</start_date>
  <completion_date type="Actual">January 15, 2019</completion_date>
  <primary_completion_date type="Actual">January 15, 2019</primary_completion_date>
  <phase>N/A</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>Development Of CIN (Contrast-Induced Nephropathy) (&gt; 25% baseline creatinine) in both groups.</measure>
    <time_frame>Day 2</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean change in serum creatinine from baseline in both groups</measure>
    <time_frame>Day 2</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean change in serum creatinine from baseline in both groups</measure>
    <time_frame>Day 6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events of N-Acteyl Cysteine in both groups</measure>
    <time_frame>Day 6</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Liver Cirrhoses</condition>
  <arm_group>
    <arm_group_label>NAC Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>NAC 1200 mg twice daily one day prior to the procedure and on the day of the procedure.</description>
  </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>N-Acetyl Cysteine</intervention_name>
    <description>NAC 1200 mg twice daily one day prior to the procedure and on the day of the procedure.</description>
    <arm_group_label>NAC Arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo Oral Tablet</intervention_name>
    <description>Placebo Oral Tablet twice daily.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age-18-70 years&#xD;
&#xD;
          -  Normal kidney parameters (Creatinine below &lt;1 ,Creatinine clearance &gt;60)&#xD;
&#xD;
          -  Cirrhosis of liver&#xD;
&#xD;
          -  eGFR&gt;60ml/min&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Chronic kidney disease&#xD;
&#xD;
          -  H/o anaphylaxis to contrast&#xD;
&#xD;
          -  Prior h/o AKI&#xD;
&#xD;
          -  GFR&lt;60 ML/MIN&#xD;
&#xD;
          -  Prior H/o TACE/HVPG /Contrast ECHO in the last 4 weeks&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Institute of Liver and Biliary Sciences</name>
      <address>
        <city>New Delhi</city>
        <state>Delhi</state>
        <zip>110070</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>November 28, 2018</study_first_submitted>
  <study_first_submitted_qc>November 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 29, 2018</study_first_posted>
  <last_update_submitted>November 1, 2019</last_update_submitted>
  <last_update_submitted_qc>November 1, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 4, 2019</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>Liver Cirrhosis</mesh_term>
    <mesh_term>Fibrosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acetylcysteine</mesh_term>
    <mesh_term>N-monoacetylcystine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03759158
org study id: ILBS-Cirrhosis-19
nct id: NCT03759158
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Contrast induced nephropathy has an incidence of 7-11 % in patients undergoing Contrast
      imaging for various conditions. The risk associated with the development of CIN are still
      under evaluation. Even with patients having normal kidney functions there is a risk of
      contrast induced nephropathy hence the need for markers which could predict injury. Cirrhosis
      of liver predisposes patient to Kidney abnormalities as these patients lower renal reserve
      and can have various conditions like Hepatorenal syndrome, Sepsis, ATN. Contrast imaging is
      vital for ruling out conditions like Hepatocellular Carcinoma in patients of cirrhosis of
      liver. Presently there is no study in cirrhosis of liver which studies the Effect of N-acetyl
      cysteine before and after contrast imaging in the prevention Of CIN. The incidence of CNI is
      cirrhosis is also an avenue which requires more studies and also there is a need for
      formulation of a Score to predict this CIN. Hence this study is being done to assess the
      incidence of CNI and the role of N-Acetyl cysteine in Preventing CNI.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Development Of CIN (Contrast-Induced Nephropathy) (> 25% baseline creatinine) in both groups.
time frame: Day 2
measure: Mean change in serum creatinine from baseline in both groups
time frame: Day 2
measure: Mean change in serum creatinine from baseline in both groups
time frame: Day 6
measure: Adverse events of N-Acteyl Cysteine in both groups
time frame: Day 6
arm group label: NAC Arm
arm group type: Experimental
description: NAC 1200 mg twice daily one day prior to the procedure and on the day of the procedure.
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: N-Acetyl Cysteine
description: NAC 1200 mg twice daily one day prior to the procedure and on the day of the procedure.
arm group label: NAC Arm
intervention type: Drug
intervention name: Placebo Oral Tablet
description: Placebo Oral Tablet twice daily.
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
country: India
responsible party type: Sponsor
mesh term: Liver Cirrhosis
mesh term: Fibrosis
mesh term: Acetylcysteine
mesh term: N-monoacetylcystine
sharing ipd: Undecided