<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/NCT03006952</url>
  </required_header>
  <id_info>
    <org_study_id>931133003</org_study_id>
    <nct_id>NCT03006952</nct_id>
  </id_info>
  <brief_title>Add-on Pentoxifylline to Losartan Versus Increasing Dose of Losartan on NT-PRO BNP in Type 2 Diabetics With Nephropathy</brief_title>
  <official_title>Comparative Effects of add-on Pentoxifylline to Losartan Versus Increasing Dose of Losartan on Serum NT-PRO BNP and Proteinuria in Type 2 Diabetics With Nephropathy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tehran University of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tehran University of Medical Sciences</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study was designed to assess the efficacy of adding pentoxifylline to losartan in&#xD;
      comparison with increasing dose of losartan in type 2 diabetes patients with nephropathy.&#xD;
      also the effect of pentoxifylline on N terminal brain natriuretic peptide (NT-pro BNP) and&#xD;
      C-reactive protein&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Addition of pentoxifylline to losartan provides antiproteinuric effects in type 2 diabetes&#xD;
      patients with nephropathy that might relate to its effect on N terminal brain natriuretic&#xD;
      peptide (NT-pro BNP) and C-reactive protein.&#xD;
&#xD;
      Pentoxifylline is a phosphodiestrase inhibitor with anti-inflammatory effects that was used&#xD;
      in type 2 diabetes patients with nephropathy for treatment of diabetes complications.&#xD;
&#xD;
      NT-Pro BNP, which is released from the heart due to wall stress and pressures, is known as a&#xD;
      diagnostic and prognostic marker for heart failure and cardiovascular mortality in type 2&#xD;
      diabetes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2015</start_date>
  <completion_date type="Actual">September 2015</completion_date>
  <primary_completion_date type="Actual">September 2015</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>N terminal brain natriuretic peptide (NT-pro BNP)</measure>
    <time_frame>3 months</time_frame>
    <description>N terminal brain natriuretic peptide assessed using ELISA method (zelbio, Germany) with inter- and intra-assay coefficient of variation (CV) &lt;12% and &lt;10%. Measured at baseline, 3rd month</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Highly sensitive C-reactive protein (hsCRP)</measure>
    <time_frame>3 months</time_frame>
    <description>Highly sensitive C-reactive protein assessed by commercial kits (DRG kit, Germany) using the ELISA (enzyme-linked immunosorbent assay) method with inter- and intra-assay coefficient of variation (CV) of &lt;20%. Measured at baseline, 3rd month</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urinary albumin excretion</measure>
    <time_frame>3 months</time_frame>
    <description>Urinary albumin excretion assessed by overnight (12 hour) collection of urine. Measured at baseline, 3rd month</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood pressure</measure>
    <time_frame>3 months</time_frame>
    <description>Systolic and diastolic blood pressure assessed by mercury sphygnomanometry. Patients were placed in a sitting position and after ten minutes rest, two readings from right-side hand with five minutes interval were obtained. Measured at baseline, 3rd month</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>estimated glomerular filtration rate</measure>
    <time_frame>3 months</time_frame>
    <description>estimated glomerular filtration rate calculated using the formula developed by Chronic Kidney Disease Epidemiology Collaboration. Measured at baseline, 3rd month</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>serum creatinine concentrations</measure>
    <time_frame>3 months</time_frame>
    <description>serum creatinine concentrations assessed by Jaffe method. Measured at baseline, 3rd month</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">59</enrollment>
  <condition>Diabetic Nephropathies</condition>
  <arm_group>
    <arm_group_label>pentoxifylline &amp; losartan</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>pentoxifylline arm took 400 mg pentoxifylline twice daily plus 50mg losartan daily for 12 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Losartan</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>losartan arm took 100mg losartan daily for 12 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pentoxifylline</intervention_name>
    <description>pentoxifylline arm took 400 mg pentoxifylline twice daily plus 50mg losartan daily for 12 weeks.</description>
    <arm_group_label>pentoxifylline &amp; losartan</arm_group_label>
    <other_name>oxpentifylline</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Losartan</intervention_name>
    <description>losartan arm took 100mg losartan daily for 12 weeks.</description>
    <arm_group_label>Losartan</arm_group_label>
    <arm_group_label>pentoxifylline &amp; losartan</arm_group_label>
    <other_name>Cozaar</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age&gt;30 and age&lt;70, urinary albumin excretion (UAE) ≥150 mg/24 h&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  any infectious or malignant diseases, non-diabetic kidney disease, retinal hemorrhage,&#xD;
             acute myocardial infarction, uncontrolled hypertension, pregnancy, unable to follow&#xD;
             up, hyperthyroidism, baseline serum potassium concentrations ≥5.5 meq/L, glomerular&#xD;
             filtration rate (GFR)&lt;30mL/min/1.73 m and intolerance of pentoxifylline&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>38 Years</minimum_age>
    <maximum_age>76 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alireza Esteghamati, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Endocrinology and Metabolism Research Center (EMRC), Vali-Asr Hospital, Tehran University of Medical Sciences, Tehran, Iran</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Tehran University of Medical Sciences</name>
      <address>
        <city>Tehran</city>
        <country>Iran, Islamic Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Iran, Islamic Republic of</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 24, 2016</study_first_submitted>
  <study_first_submitted_qc>December 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 30, 2016</study_first_posted>
  <last_update_submitted>December 29, 2016</last_update_submitted>
  <last_update_submitted_qc>December 29, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 30, 2016</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>Diabetic Nephropathies</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Losartan</mesh_term>
    <mesh_term>Pentoxifylline</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</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/NCT03006952
org study id: 931133003
nct id: NCT03006952
lead sponsor: 
has dmc: Yes
This study was designed to assess the efficacy of adding pentoxifylline to losartan in
      comparison with increasing dose of losartan in type 2 diabetes patients with nephropathy.
      also the effect of pentoxifylline on N terminal brain natriuretic peptide (NT-pro BNP) and
      C-reactive protein
Addition of pentoxifylline to losartan provides antiproteinuric effects in type 2 diabetes
      patients with nephropathy that might relate to its effect on N terminal brain natriuretic
      peptide (NT-pro BNP) and C-reactive protein.

      Pentoxifylline is a phosphodiestrase inhibitor with anti-inflammatory effects that was used
      in type 2 diabetes patients with nephropathy for treatment of diabetes complications.

      NT-Pro BNP, which is released from the heart due to wall stress and pressures, is known as a
      diagnostic and prognostic marker for heart failure and cardiovascular mortality in type 2
      diabetes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: N terminal brain natriuretic peptide (NT-pro BNP)
time frame: 3 months
description: N terminal brain natriuretic peptide assessed using ELISA method (zelbio, Germany) with inter- and intra-assay coefficient of variation (CV) <12% and <10%. Measured at baseline, 3rd month
measure: Highly sensitive C-reactive protein (hsCRP)
time frame: 3 months
description: Highly sensitive C-reactive protein assessed by commercial kits (DRG kit, Germany) using the ELISA (enzyme-linked immunosorbent assay) method with inter- and intra-assay coefficient of variation (CV) of <20%. Measured at baseline, 3rd month
measure: Urinary albumin excretion
time frame: 3 months
description: Urinary albumin excretion assessed by overnight (12 hour) collection of urine. Measured at baseline, 3rd month
measure: Blood pressure
time frame: 3 months
description: Systolic and diastolic blood pressure assessed by mercury sphygnomanometry. Patients were placed in a sitting position and after ten minutes rest, two readings from right-side hand with five minutes interval were obtained. Measured at baseline, 3rd month
measure: estimated glomerular filtration rate
time frame: 3 months
description: estimated glomerular filtration rate calculated using the formula developed by Chronic Kidney Disease Epidemiology Collaboration. Measured at baseline, 3rd month
measure: serum creatinine concentrations
time frame: 3 months
description: serum creatinine concentrations assessed by Jaffe method. Measured at baseline, 3rd month
arm group label: pentoxifylline & losartan
arm group type: Active Comparator
description: pentoxifylline arm took 400 mg pentoxifylline twice daily plus 50mg losartan daily for 12 weeks.
arm group label: Losartan
arm group type: Active Comparator
description: losartan arm took 100mg losartan daily for 12 weeks.
intervention type: Drug
intervention name: Pentoxifylline
description: pentoxifylline arm took 400 mg pentoxifylline twice daily plus 50mg losartan daily for 12 weeks.
arm group label: pentoxifylline & losartan
other name: oxpentifylline
intervention type: Drug
intervention name: Losartan
description: losartan arm took 100mg losartan daily for 12 weeks.
arm group label: Losartan
arm group label: pentoxifylline & losartan
other name: Cozaar
criteria: 
gender: All
minimum age: 38 Years
maximum age: 76 Years
healthy volunteers: No
last name: Alireza Esteghamati, MD
role: Study Chair
affiliation: Endocrinology and Metabolism Research Center (EMRC), Vali-Asr Hospital, Tehran University of Medical Sciences, Tehran, Iran
facility: 
country: Iran, Islamic Republic of
responsible party type: Sponsor
mesh term: Kidney Diseases
mesh term: Diabetic Nephropathies
mesh term: Losartan
mesh term: Pentoxifylline
sharing ipd: Yes