<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/NCT01675362</url>
  </required_header>
  <id_info>
    <org_study_id>4228</org_study_id>
    <nct_id>NCT01675362</nct_id>
  </id_info>
  <brief_title>Are There Protective Effects of Antioxidants, Calcium Channel Blocker and Angiotensin Receptor Blocker Against Extracorporeal Shockwaves Lithotripsy Induced Renal Injury?</brief_title>
  <acronym>SWL</acronym>
  <official_title>A Randomized Controlled Trial for Evaluating Protective Effects of Antioxidants (Selenium and Vitamins A, C and E), Calcium Channel Blocker (Verapamil) and Angiotensin Receptor Blocker (Losartan) Against Extracorporeal Shockwaves Lithotripsy Induced Renal Injury</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mansoura University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mansoura University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will be conducted to evaluate the protective effects and mechanisms of&#xD;
      antioxidants (vitamins A, C, E and Selenium), calcium channel blocker (Verapamil) and&#xD;
      angiotensin receptor blocker (Lozartan) against shock wave induced renal injuries.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The protective effect will be evaluated via estimation of the changes in renal tubular enzyme&#xD;
      (NGAL) and detection of albumen levels in urine. The mechanisms of protection will be&#xD;
      investigated by estimation of renal perfusion and functional changes using dynamic MRI.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">October 2014</completion_date>
  <primary_completion_date type="Actual">August 2014</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Renal damage</measure>
    <time_frame>two hours and one week after Extracorporeal shock wave lithotripsy (ESWL)</time_frame>
    <description>The protective effect will be evaluated via estimation of the changes in renal tubular enzyme (NGAL) and detection of albumen levels in urine.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The mechanisms of renal protection</measure>
    <time_frame>Before ESWL, 2 hours and 1 week after ESWL</time_frame>
    <description>The mechanisms of protection will be investigated by estimation of renal perfusion and functional changes using dynamic MRI</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">160</enrollment>
  <condition>Kidney Calculi</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>They will receive placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Antioxidant group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>They will be receive vitamins A, C, E and selenium (Selenium ACE) Dosage: Two tablets before ESWL Then 2 tablets every 8 hours after ESWL for one week</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Calcium channel Blockers</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>They will receive Verapamil (Isoptin 80 mg) Dosage: One tablet 2 hours before ESWL Then one tablet every 12 hours after ESWL for one week</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Angiotensin receptor blocker group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>They will receive Losartan (Cozaar 50 mg) Dosage: One tablet 2 hours before ESWL Then one tablet every day after ESWL for one week</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Antioxidant group</intervention_name>
    <description>They will be receive vitamins A, C, E and selenium (Selenium ACE) Dosage: Two tablets before ESWL Then 2 tablets every 8 hours after ESWL for one week</description>
    <arm_group_label>Antioxidant group</arm_group_label>
    <other_name>Selenium ACE</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Calcium Channel Blockers</intervention_name>
    <description>They will receive Verapamil (Isoptin 80 mg) Dosage: One tablet 2 hours before ESWL Then one tablet every 12 hours after ESWL for one week</description>
    <arm_group_label>Calcium channel Blockers</arm_group_label>
    <other_name>Verapamil</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Angiotensin receptor blocker group</intervention_name>
    <description>They will receive Losartan (Cozaar 50 mg) Dosage: One tablet 2 hours before ESWL Then one tablet every day after ESWL for one week</description>
    <arm_group_label>Angiotensin receptor blocker group</arm_group_label>
    <other_name>Losartan</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>They will receive placebo</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Well functioning kidney (serum creatinine &lt;1.2 mg/dl).&#xD;
&#xD;
          2. Solitary renal stone.&#xD;
&#xD;
          3. Size: 25 mm or less in the largest diameter.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Contraindications to ESWL&#xD;
&#xD;
          2. Previous surgical treatment of renal stones.&#xD;
&#xD;
          3. Congenital renal anomalies.&#xD;
&#xD;
          4. Pediatric patients (age &lt;18 years).&#xD;
&#xD;
          5. Patients with Diabetes or hypertension&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ahmed R. EL-Nahas, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mansoura University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Urology and Nephrology Center</name>
      <address>
        <city>Mansoura</city>
        <zip>35516</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>August 27, 2012</study_first_submitted>
  <study_first_submitted_qc>August 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 29, 2012</study_first_posted>
  <last_update_submitted>October 8, 2014</last_update_submitted>
  <last_update_submitted_qc>October 8, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 9, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mansoura University</investigator_affiliation>
    <investigator_full_name>Ahmed R. EL-Nahas</investigator_full_name>
    <investigator_title>Assistant Professor of Urology</investigator_title>
  </responsible_party>
  <keyword>Extracorporeal shockwave lithotripsy (ESWL)</keyword>
  <keyword>Kidney calculi</keyword>
  <keyword>Renal protection</keyword>
  <keyword>Antioxidants</keyword>
  <keyword>Calcium channel blockers</keyword>
  <keyword>Angiotensin receptor blockers</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Calculi</mesh_term>
    <mesh_term>Nephrolithiasis</mesh_term>
    <mesh_term>Calculi</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Selenium</mesh_term>
    <mesh_term>Losartan</mesh_term>
    <mesh_term>Verapamil</mesh_term>
    <mesh_term>Calcium Channel Blockers</mesh_term>
    <mesh_term>Calcium</mesh_term>
    <mesh_term>Angiotensin Receptor Antagonists</mesh_term>
    <mesh_term>Antioxidants</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/NCT01675362
org study id: 4228
nct id: NCT01675362
lead sponsor: 
has dmc: Yes
This study will be conducted to evaluate the protective effects and mechanisms of
      antioxidants (vitamins A, C, E and Selenium), calcium channel blocker (Verapamil) and
      angiotensin receptor blocker (Lozartan) against shock wave induced renal injuries.
The protective effect will be evaluated via estimation of the changes in renal tubular enzyme
      (NGAL) and detection of albumen levels in urine. The mechanisms of protection will be
      investigated by estimation of renal perfusion and functional changes using dynamic MRI.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Care Provider, Investigator)
measure: Renal damage
time frame: two hours and one week after Extracorporeal shock wave lithotripsy (ESWL)
description: The protective effect will be evaluated via estimation of the changes in renal tubular enzyme (NGAL) and detection of albumen levels in urine.
measure: The mechanisms of renal protection
time frame: Before ESWL, 2 hours and 1 week after ESWL
description: The mechanisms of protection will be investigated by estimation of renal perfusion and functional changes using dynamic MRI
arm group label: Control group
arm group type: Placebo Comparator
description: They will receive placebo
arm group label: Antioxidant group
arm group type: Active Comparator
description: They will be receive vitamins A, C, E and selenium (Selenium ACE) Dosage: Two tablets before ESWL Then 2 tablets every 8 hours after ESWL for one week
arm group label: Calcium channel Blockers
arm group type: Active Comparator
description: They will receive Verapamil (Isoptin 80 mg) Dosage: One tablet 2 hours before ESWL Then one tablet every 12 hours after ESWL for one week
arm group label: Angiotensin receptor blocker group
arm group type: Active Comparator
description: They will receive Losartan (Cozaar 50 mg) Dosage: One tablet 2 hours before ESWL Then one tablet every day after ESWL for one week
intervention type: Drug
intervention name: Antioxidant group
description: They will be receive vitamins A, C, E and selenium (Selenium ACE) Dosage: Two tablets before ESWL Then 2 tablets every 8 hours after ESWL for one week
arm group label: Antioxidant group
other name: Selenium ACE
intervention type: Drug
intervention name: Calcium Channel Blockers
description: They will receive Verapamil (Isoptin 80 mg) Dosage: One tablet 2 hours before ESWL Then one tablet every 12 hours after ESWL for one week
arm group label: Calcium channel Blockers
other name: Verapamil
intervention type: Drug
intervention name: Angiotensin receptor blocker group
description: They will receive Losartan (Cozaar 50 mg) Dosage: One tablet 2 hours before ESWL Then one tablet every day after ESWL for one week
arm group label: Angiotensin receptor blocker group
other name: Losartan
intervention type: Drug
intervention name: Placebo
description: They will receive placebo
arm group label: Control group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Ahmed R. EL-Nahas, MD
role: Principal Investigator
affiliation: Mansoura University
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Mansoura University
investigator full name: Ahmed R. EL-Nahas
investigator title: Assistant Professor of Urology
mesh term: Kidney Calculi
mesh term: Nephrolithiasis
mesh term: Calculi
mesh term: Selenium
mesh term: Losartan
mesh term: Verapamil
mesh term: Calcium Channel Blockers
mesh term: Calcium
mesh term: Angiotensin Receptor Antagonists
mesh term: Antioxidants