<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/NCT03812419</url>
  </required_header>
  <id_info>
    <org_study_id>7-2015/22</org_study_id>
    <nct_id>NCT03812419</nct_id>
  </id_info>
  <brief_title>Esomeprazole or Pantoprazole in Renal Transplantation</brief_title>
  <official_title>The Effect of Esomeprazole Versus Pantoprazole on Serum Cyclosporine Levels and Renal Function in Stable Kidney Transplant Recipients: A Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Future University in Egypt</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ain Shams University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Nasser Institute For Research and Treatment</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Future University in Egypt</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      prospective, parallel, open-label clinical trial was performed on forty-seven adult renal&#xD;
      transplant recipients receiving immunosuppressive therapy with CsA doses adjusted to attain&#xD;
      trough concentrations of 100-150 μg/L, mycophenolate mofetil (MMF) at 750 mg q12 hr and&#xD;
      prednisolone at 5 mg daily randomized into two groups, which received esomeprazole or&#xD;
      pantoprazole at the same dose (40 mg once daily). To compare the influence of pantoprazole&#xD;
      and esomeprazole on serum cyclosporine (CsA) levels in stable renal transplant&#xD;
      recipients.Cyclosporine (C0), renal function and complete blood count were measured at&#xD;
      baseline and for 6 months. Main outcome measures Clinical signs of rejection and renal&#xD;
      function decline, assessed by serum creatinine elevations, caused by CsA level variations in&#xD;
      either of the study groups.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study design and settings: This study is a prospective, single-centre, randomized, parallel,&#xD;
      open-label 1:1 consecutive clinical trial of renal transplant recipients, with a follow-up 6&#xD;
      months; the study included an esomeprazole group (n = 25 at study completion) and a&#xD;
      pantoprazole group (n = 22 at study completion). The study was conducted in the renal&#xD;
      transplantation unit of the Nasser Institute in Cairo, Egypt.&#xD;
&#xD;
      Eighty renal transplant recipients were screened for eligibility. The sample size was&#xD;
      determined by a power calculation using G power software version 3.0.10; the selected sample&#xD;
      size showed an actual power of 0.95, α = 0.5 and an effect size of 0.8 for C0 levels of CsA&#xD;
      and an actual power of 0.95, α = 0.5 and an effect size of 0.44 for serum creatinine&#xD;
      levels.The participants were randomly assigned to one of two groups by single randomization.&#xD;
      Each group received PPI therapy with a 40 mg/day dose of either esomeprazole (Ezogast; Copad&#xD;
      Pharma, Cairo, Egypt) in group I (n = 25 at study completion) or pantoprazole (Pantoprazole;&#xD;
      Pharo Pharma, Alexandria, Egypt) in group II (n = 22 at study completion).&#xD;
&#xD;
      In addition, participants continued to receive the immunosuppressant combination of CsA&#xD;
      (Sandimmune; Novartis, East Hanover, NJ, USA), MMF (Cellcept; Roche, Basel, Switzerland) and&#xD;
      the corticosteroid prednisolone (Solupred; Sanofi Aventis, Tours, France).&#xD;
&#xD;
      Administration: CsA was administered in two divided doses adjusted to achieve a C0 of 100-150&#xD;
      µg/L according to the transplantation centre protocol for maintenance blood CsA levels. The&#xD;
      morning was dose separated from PPIs by at least 15 minutes, with MMF administered at 750 mg&#xD;
      q12 hr and prednisolone administered at 5 mg daily. Each group received 40 mg/day PPI therapy&#xD;
      on an empty stomach, and all medications were taken orally.&#xD;
&#xD;
      Renal function tests Included Parameter Assay Kits Serum creatinine QuantiChrom creatinine&#xD;
      assay kit Blood urea nitrogen QuantiChrom urea assay kit Serum uric acid QuantiChrom uric&#xD;
      acid assay kit Complete blood count measurements included Parameter Assay Kits Haemoglobin&#xD;
      White blood cells (WBCs) UniCel DxH 800 Coulter Cellular Analysis System Platelets&#xD;
&#xD;
      Whole-blood C0 values in morning samples were determined spectrophotometrically using the&#xD;
      CEDIA Cyclosporine PLUS Assay and the Indiko Plus Benchtop Analyzer (Thermo Fisher&#xD;
      Scientific, Waltham, MA, USA)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 5, 2016</start_date>
  <completion_date type="Actual">December 30, 2016</completion_date>
  <primary_completion_date type="Actual">December 10, 2016</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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Serum CsA (C0) level</measure>
    <time_frame>up to 30 weeks from date of randomization untill date of any documented change in the serum concentration</time_frame>
    <description>trough CsA serum levels in µg/L</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Serum creatinine</measure>
    <time_frame>up to 30 weeks from date of randomization untill date of any documented change in the serum concentration</time_frame>
    <description>serum creatinine concentration in mg/dl</description>
  </secondary_outcome>
  <other_outcome>
    <measure>number of participants with signs of rejection</measure>
    <time_frame>up to 30 weeks from date of randomization untill date of any documented rejectionoccurence of</time_frame>
    <description>Fever , falnk pain , anuria</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">47</enrollment>
  <condition>Kidney Transplant; Complications</condition>
  <arm_group>
    <arm_group_label>group I</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Esomeprazole 40 mg capsules once daily for 6 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>group II</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Pantoprazole 40 mg tablets once daily for 6 months</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Esomeprazole 40 mg</intervention_name>
    <description>Esomeprazole 40 mg In addition, the immunosuppressant combination of CsA (Sandimmune; Novartis, East Hanover, NJ, USA), MMF (Cellcept; Roche, Basel, Switzerland) and the corticosteroid prednisolone (Solupred; Sanofi Aventis, Tours, France).</description>
    <arm_group_label>group I</arm_group_label>
    <other_name>Ezogast</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pantoprazole 40mg</intervention_name>
    <description>Pantoprazole 40 mg In addition, the immunosuppressant combination of CsA (Sandimmune; Novartis, East Hanover, NJ, USA), MMF (Cellcept; Roche, Basel, Switzerland) and the corticosteroid prednisolone (Solupred; Sanofi Aventis, Tours, France).</description>
    <arm_group_label>group II</arm_group_label>
    <other_name>Pantoprazole</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  stable adult renal transplant recipients&#xD;
&#xD;
          -  participants continued the same maintenance triple immunosuppressive therapy,&#xD;
&#xD;
          -  triple immunosuppressive therapy was received for at least 3 years prior to the study&#xD;
&#xD;
          -  transplanted 5 years before the start of the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Paediatric patients&#xD;
&#xD;
          -  patients &gt; 65 years old&#xD;
&#xD;
          -  multi-organ transplant recipients&#xD;
&#xD;
          -  pregnant or lactating patients&#xD;
&#xD;
          -  patients with malignancies,&#xD;
&#xD;
          -  patients with active infection or inflammation&#xD;
&#xD;
          -  pre-transplant GI tract disorders&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Doaa MS ElBohy, M.Sc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Future University in Egypt</affiliation>
  </overall_official>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 12, 2019</study_first_submitted>
  <study_first_submitted_qc>January 19, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>January 22, 2019</last_update_submitted>
  <last_update_submitted_qc>January 22, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 24, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Future University in Egypt</investigator_affiliation>
    <investigator_full_name>Doaa Mohamed Salah ElDin Diab ELBohy</investigator_full_name>
    <investigator_title>lecturer assisstant</investigator_title>
  </responsible_party>
  <keyword>Allograft rejection</keyword>
  <keyword>cyclosporine</keyword>
  <keyword>kidney transplantation</keyword>
  <keyword>proton pump inhibitors</keyword>
  <keyword>gastric complications.</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Esomeprazole</mesh_term>
    <mesh_term>Pantoprazole</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03812419
org study id: 7-2015/22
nct id: NCT03812419
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
prospective, parallel, open-label clinical trial was performed on forty-seven adult renal
      transplant recipients receiving immunosuppressive therapy with CsA doses adjusted to attain
      trough concentrations of 100-150 μg/L, mycophenolate mofetil (MMF) at 750 mg q12 hr and
      prednisolone at 5 mg daily randomized into two groups, which received esomeprazole or
      pantoprazole at the same dose (40 mg once daily). To compare the influence of pantoprazole
      and esomeprazole on serum cyclosporine (CsA) levels in stable renal transplant
      recipients.Cyclosporine (C0), renal function and complete blood count were measured at
      baseline and for 6 months. Main outcome measures Clinical signs of rejection and renal
      function decline, assessed by serum creatinine elevations, caused by CsA level variations in
      either of the study groups.
Study design and settings: This study is a prospective, single-centre, randomized, parallel,
      open-label 1:1 consecutive clinical trial of renal transplant recipients, with a follow-up 6
      months; the study included an esomeprazole group (n = 25 at study completion) and a
      pantoprazole group (n = 22 at study completion). The study was conducted in the renal
      transplantation unit of the Nasser Institute in Cairo, Egypt.

      Eighty renal transplant recipients were screened for eligibility. The sample size was
      determined by a power calculation using G power software version 3.0.10; the selected sample
      size showed an actual power of 0.95, α = 0.5 and an effect size of 0.8 for C0 levels of CsA
      and an actual power of 0.95, α = 0.5 and an effect size of 0.44 for serum creatinine
      levels.The participants were randomly assigned to one of two groups by single randomization.
      Each group received PPI therapy with a 40 mg/day dose of either esomeprazole (Ezogast; Copad
      Pharma, Cairo, Egypt) in group I (n = 25 at study completion) or pantoprazole (Pantoprazole;
      Pharo Pharma, Alexandria, Egypt) in group II (n = 22 at study completion).

      In addition, participants continued to receive the immunosuppressant combination of CsA
      (Sandimmune; Novartis, East Hanover, NJ, USA), MMF (Cellcept; Roche, Basel, Switzerland) and
      the corticosteroid prednisolone (Solupred; Sanofi Aventis, Tours, France).

      Administration: CsA was administered in two divided doses adjusted to achieve a C0 of 100-150
      µg/L according to the transplantation centre protocol for maintenance blood CsA levels. The
      morning was dose separated from PPIs by at least 15 minutes, with MMF administered at 750 mg
      q12 hr and prednisolone administered at 5 mg daily. Each group received 40 mg/day PPI therapy
      on an empty stomach, and all medications were taken orally.

      Renal function tests Included Parameter Assay Kits Serum creatinine QuantiChrom creatinine
      assay kit Blood urea nitrogen QuantiChrom urea assay kit Serum uric acid QuantiChrom uric
      acid assay kit Complete blood count measurements included Parameter Assay Kits Haemoglobin
      White blood cells (WBCs) UniCel DxH 800 Coulter Cellular Analysis System Platelets

      Whole-blood C0 values in morning samples were determined spectrophotometrically using the
      CEDIA Cyclosporine PLUS Assay and the Indiko Plus Benchtop Analyzer (Thermo Fisher
      Scientific, Waltham, MA, USA)
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Serum CsA (C0) level
time frame: up to 30 weeks from date of randomization untill date of any documented change in the serum concentration
description: trough CsA serum levels in µg/L
measure: Serum creatinine
time frame: up to 30 weeks from date of randomization untill date of any documented change in the serum concentration
description: serum creatinine concentration in mg/dl
measure: number of participants with signs of rejection
time frame: up to 30 weeks from date of randomization untill date of any documented rejectionoccurence of
description: Fever , falnk pain , anuria
arm group label: group I
arm group type: Active Comparator
description: Esomeprazole 40 mg capsules once daily for 6 months
arm group label: group II
arm group type: Active Comparator
description: Pantoprazole 40 mg tablets once daily for 6 months
intervention type: Drug
intervention name: Esomeprazole 40 mg
description: Esomeprazole 40 mg In addition, the immunosuppressant combination of CsA (Sandimmune; Novartis, East Hanover, NJ, USA), MMF (Cellcept; Roche, Basel, Switzerland) and the corticosteroid prednisolone (Solupred; Sanofi Aventis, Tours, France).
arm group label: group I
other name: Ezogast
intervention type: Drug
intervention name: Pantoprazole 40mg
description: Pantoprazole 40 mg In addition, the immunosuppressant combination of CsA (Sandimmune; Novartis, East Hanover, NJ, USA), MMF (Cellcept; Roche, Basel, Switzerland) and the corticosteroid prednisolone (Solupred; Sanofi Aventis, Tours, France).
arm group label: group II
other name: Pantoprazole
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Doaa MS ElBohy, M.Sc
role: Principal Investigator
affiliation: Future University in Egypt
responsible party type: Principal Investigator
investigator affiliation: Future University in Egypt
investigator full name: Doaa Mohamed Salah ElDin Diab ELBohy
investigator title: lecturer assisstant
mesh term: Esomeprazole
mesh term: Pantoprazole
sharing ipd: No