<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/NCT03800433</url>
  </required_header>
  <id_info>
    <org_study_id>pentoxifylline in hemodialysis</org_study_id>
    <nct_id>NCT03800433</nct_id>
  </id_info>
  <brief_title>Pentoxifylline Administration in Hemodialysis Patients</brief_title>
  <official_title>Impact of Pentoxifylline Administration on the Modulation of Hyporesponsiveness to Erythropoietin Stimulating Agents in Hemodialysis Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ain Shams University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ain Shams University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study is to assess the impact of pentoxifylline administration on the&#xD;
      modulation of hyporesponsiveness to erythropoietin stimulating agents in hemodialysis&#xD;
      patients&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      this is a prospective, randomized, controlled study to assess the impact of pentoxifylline&#xD;
      administration on the modulation of hyporesponsiveness to erythropoietin stimulating agents&#xD;
      in hemodialysis patients by determining several outcomes from the intervention and control&#xD;
      groups at the end of the study.These outcomes include;the difference in hemoglobin and&#xD;
      hematocrit concentration , the difference in inflammatory markers tumor necrosis factor Alpha&#xD;
      (TNF-α), interleukin-1 Beta (IL-1β),the difference in the dosage of erythropoiesis&#xD;
      stimulating agents ,and The erythropoietin stimulating agents (ESA) resistance index (ERI).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">October 2019</start_date>
  <completion_date type="Anticipated">April 2020</completion_date>
  <primary_completion_date type="Anticipated">April 2020</primary_completion_date>
  <phase>Early Phase 1</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 difference in hemoglobin and hematocrit concentration between the intervention and control groups at the end of the study</measure>
    <time_frame>up to 6 months post baseline</time_frame>
    <description>Patients will be evaluated regularly every month for hemoglobin concentration</description>
  </primary_outcome>
  <primary_outcome>
    <measure>safety &amp; tolerability of pentoxifylline ( frequency of adverse drug effects due to Pentoxifylline as well as compliance with pentoxifylline).</measure>
    <time_frame>up to 6 months post baseline</time_frame>
    <description>Patients will be evaluated regularly for frequency of adverse drug effects due to Pentoxifylline as well as compliance with pentoxifylline</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Inflammatory markers TNF-a, IL-1β.</measure>
    <time_frame>up to 6 months post baseline</time_frame>
    <description>patient will be subjected to laboratory evaluation for estimation of IL-1β,TNF-α levels at baseline as well as end of study evaluation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in the dosage of erythropoiesis stimulating agents.</measure>
    <time_frame>up to 6 months post baseline</time_frame>
    <description>the dose of ESA will be assessed at end of study evaluation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The ESA ( erythropoiesis stimulating agents)resistance index (ERI).</measure>
    <time_frame>up to 6 months post baseline</time_frame>
    <description>ERI will be assessed for patients by determining ESA dose and hemoglobin concentration</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">46</enrollment>
  <condition>Anemia Renal</condition>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>23 patients will receive their usual dose of erythropoietin stimulating agents and their routine treatment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>test</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>23 patients will receive the intervention drug Pentoxifylline (Trental 400 milligram(MG) Extended Release Oral Tablet) twice daily in addition their usual dose of erythropoietin stimulating agents and their routine treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Trental 400 MG Extended Release Oral Tablet</intervention_name>
    <description>oral tablets</description>
    <arm_group_label>test</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults (18 years or over).&#xD;
&#xD;
          -  Stable hemodialysis &gt;6 months.&#xD;
&#xD;
          -  Regular haemodialysis (3 times/ week).&#xD;
&#xD;
          -  ESA resistant anemia (Hb &lt;10 mg/dl for 6 mo.).&#xD;
&#xD;
          -  ESA dose of &gt;8000 IU/wk.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inadequate hemodialysis.&#xD;
&#xD;
          -  Hyperparathyroidism (PTH&gt;800 pg/l).&#xD;
&#xD;
          -  Known hypersensitivity to, or intolerance of Pentoxifylline.&#xD;
&#xD;
          -  Absolute or functional iron deficiency (ferritin &lt; 100 μg/L and/or transferrin&#xD;
             saturation &lt; 20%).&#xD;
&#xD;
          -  Presence of systemic haematological disease (including antibody-mediated pure red cell&#xD;
             aplasia) or known haemoglobinopathy.&#xD;
&#xD;
          -  Major surgery, infection, inflammatory diseases, acute myocardial infarction or&#xD;
             malignancy within the last 3 months.&#xD;
&#xD;
          -  Patients with chronic liver disease and patients who had received immunosuppressive&#xD;
             therapy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lamia El Wakeel, Ass.Prof</last_name>
    <role>Study Director</role>
    <affiliation>Ass.prof clinical pharmacy</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Radwa El Borolossy, Phd</last_name>
    <role>Study Director</role>
    <affiliation>Lecturer of clinical pharmacy</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Magdy ElSharkawy, Prof.Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Prof. of nephrology</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Radwa M Elmetwaly, Bachelor</last_name>
    <phone>00201065371016</phone>
    <email>radwa_mohm@yahoo.com</email>
  </overall_contact>
  <reference>
    <citation>Weiss G, Goodnough LT. Anemia of chronic disease. N Engl J Med. 2005 Mar 10;352(10):1011-23. doi: 10.1056/NEJMra041809. No abstract available.</citation>
    <PMID>15758012</PMID>
  </reference>
  <reference>
    <citation>Johnson DW, Pollock CA, Macdougall IC. Erythropoiesis-stimulating agent hyporesponsiveness. Nephrology (Carlton). 2007 Aug;12(4):321-30. doi: 10.1111/j.1440-1797.2007.00810.x.</citation>
    <PMID>17635745</PMID>
  </reference>
  <reference>
    <citation>Cooper A, Mikhail A, Lethbridge MW, Kemeny DM, Macdougall IC. Pentoxifylline improves hemoglobin levels in patients with erythropoietin-resistant anemia in renal failure. J Am Soc Nephrol. 2004 Jul;15(7):1877-82. doi: 10.1097/01.asn.0000131523.17045.56.</citation>
    <PMID>15213276</PMID>
  </reference>
  <reference>
    <citation>Ferrari P, Mallon D, Trinder D, Olynyk JK. Pentoxifylline improves haemoglobin and interleukin-6 levels in chronic kidney disease. Nephrology (Carlton). 2010 Apr;15(3):344-9. doi: 10.1111/j.1440-1797.2009.01203.x.</citation>
    <PMID>20470305</PMID>
  </reference>
  <reference>
    <citation>Goicoechea M, Garcia de Vinuesa S, Quiroga B, Verdalles U, Barraca D, Yuste C, Panizo N, Verde E, Munoz MA, Luno J. Effects of pentoxifylline on inflammatory parameters in chronic kidney disease patients: a randomized trial. J Nephrol. 2012 Nov-Dec;25(6):969-75. doi: 10.5301/jn.5000077.</citation>
    <PMID>22241639</PMID>
  </reference>
  <reference>
    <citation>Ogawa T, Nitta K. Erythropoiesis-stimulating agent hyporesponsiveness in end-stage renal disease patients. Contrib Nephrol. 2015;185:76-86. doi: 10.1159/000380972. Epub 2015 May 19.</citation>
    <PMID>26023017</PMID>
  </reference>
  <reference>
    <citation>Shahbazian H, Ghorbani A, Zafar-Mohtashami A, Balali A, AleAli A, Lashkarara GR. Administration of pentoxifylline to improve anemia of hemodialysis patients. J Renal Inj Prev. 2016 Nov 26;6(1):61-64. doi: 10.15171/jrip.2017.11. eCollection 2017.</citation>
    <PMID>28487874</PMID>
  </reference>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>January 9, 2019</study_first_submitted>
  <study_first_submitted_qc>January 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 11, 2019</study_first_posted>
  <last_update_submitted>September 24, 2019</last_update_submitted>
  <last_update_submitted_qc>September 24, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams University</investigator_affiliation>
    <investigator_full_name>Radwa Mohamed Elmetwaly</investigator_full_name>
    <investigator_title>Post grad</investigator_title>
  </responsible_party>
  <keyword>pentoxifylline</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pentoxifylline</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/NCT03800433
org study id: pentoxifylline in hemodialysis
nct id: NCT03800433
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
The aim of the study is to assess the impact of pentoxifylline administration on the
      modulation of hyporesponsiveness to erythropoietin stimulating agents in hemodialysis
      patients
this is a prospective, randomized, controlled study to assess the impact of pentoxifylline
      administration on the modulation of hyporesponsiveness to erythropoietin stimulating agents
      in hemodialysis patients by determining several outcomes from the intervention and control
      groups at the end of the study.These outcomes include;the difference in hemoglobin and
      hematocrit concentration , the difference in inflammatory markers tumor necrosis factor Alpha
      (TNF-α), interleukin-1 Beta (IL-1β),the difference in the dosage of erythropoiesis
      stimulating agents ,and The erythropoietin stimulating agents (ESA) resistance index (ERI).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The difference in hemoglobin and hematocrit concentration between the intervention and control groups at the end of the study
time frame: up to 6 months post baseline
description: Patients will be evaluated regularly every month for hemoglobin concentration
measure: safety & tolerability of pentoxifylline ( frequency of adverse drug effects due to Pentoxifylline as well as compliance with pentoxifylline).
time frame: up to 6 months post baseline
description: Patients will be evaluated regularly for frequency of adverse drug effects due to Pentoxifylline as well as compliance with pentoxifylline
measure: Inflammatory markers TNF-a, IL-1β.
time frame: up to 6 months post baseline
description: patient will be subjected to laboratory evaluation for estimation of IL-1β,TNF-α levels at baseline as well as end of study evaluation
measure: Difference in the dosage of erythropoiesis stimulating agents.
time frame: up to 6 months post baseline
description: the dose of ESA will be assessed at end of study evaluation
measure: The ESA ( erythropoiesis stimulating agents)resistance index (ERI).
time frame: up to 6 months post baseline
description: ERI will be assessed for patients by determining ESA dose and hemoglobin concentration
arm group label: control
arm group type: No Intervention
description: 23 patients will receive their usual dose of erythropoietin stimulating agents and their routine treatment.
arm group label: test
arm group type: Experimental
description: 23 patients will receive the intervention drug Pentoxifylline (Trental 400 milligram(MG) Extended Release Oral Tablet) twice daily in addition their usual dose of erythropoietin stimulating agents and their routine treatment.
intervention type: Drug
intervention name: Trental 400 MG Extended Release Oral Tablet
description: oral tablets
arm group label: test
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Lamia El Wakeel, Ass.Prof
role: Study Director
affiliation: Ass.prof clinical pharmacy
last name: Radwa El Borolossy, Phd
role: Study Director
affiliation: Lecturer of clinical pharmacy
last name: Magdy ElSharkawy, Prof.Dr.
role: Principal Investigator
affiliation: Prof. of nephrology
last name: Radwa M Elmetwaly, Bachelor
phone: 00201065371016
email: radwa_mohm@yahoo.com
citation: Weiss G, Goodnough LT. Anemia of chronic disease. N Engl J Med. 2005 Mar 10;352(10):1011-23. doi: 10.1056/NEJMra041809. No abstract available.
PMID: 15758012
citation: Johnson DW, Pollock CA, Macdougall IC. Erythropoiesis-stimulating agent hyporesponsiveness. Nephrology (Carlton). 2007 Aug;12(4):321-30. doi: 10.1111/j.1440-1797.2007.00810.x.
PMID: 17635745
citation: Cooper A, Mikhail A, Lethbridge MW, Kemeny DM, Macdougall IC. Pentoxifylline improves hemoglobin levels in patients with erythropoietin-resistant anemia in renal failure. J Am Soc Nephrol. 2004 Jul;15(7):1877-82. doi: 10.1097/01.asn.0000131523.17045.56.
PMID: 15213276
citation: Ferrari P, Mallon D, Trinder D, Olynyk JK. Pentoxifylline improves haemoglobin and interleukin-6 levels in chronic kidney disease. Nephrology (Carlton). 2010 Apr;15(3):344-9. doi: 10.1111/j.1440-1797.2009.01203.x.
PMID: 20470305
citation: Goicoechea M, Garcia de Vinuesa S, Quiroga B, Verdalles U, Barraca D, Yuste C, Panizo N, Verde E, Munoz MA, Luno J. Effects of pentoxifylline on inflammatory parameters in chronic kidney disease patients: a randomized trial. J Nephrol. 2012 Nov-Dec;25(6):969-75. doi: 10.5301/jn.5000077.
PMID: 22241639
citation: Ogawa T, Nitta K. Erythropoiesis-stimulating agent hyporesponsiveness in end-stage renal disease patients. Contrib Nephrol. 2015;185:76-86. doi: 10.1159/000380972. Epub 2015 May 19.
PMID: 26023017
citation: Shahbazian H, Ghorbani A, Zafar-Mohtashami A, Balali A, AleAli A, Lashkarara GR. Administration of pentoxifylline to improve anemia of hemodialysis patients. J Renal Inj Prev. 2016 Nov 26;6(1):61-64. doi: 10.15171/jrip.2017.11. eCollection 2017.
PMID: 28487874
responsible party type: Principal Investigator
investigator affiliation: Ain Shams University
investigator full name: Radwa Mohamed Elmetwaly
investigator title: Post grad
mesh term: Pentoxifylline