<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/NCT03018041</url>
  </required_header>
  <id_info>
    <org_study_id>2016/1652 (REK)</org_study_id>
    <secondary_id>2016-003537-18</secondary_id>
    <nct_id>NCT03018041</nct_id>
  </id_info>
  <brief_title>The Long-term Effect of Marine Omega-3 Fatty Acid Supplementation in Renal Transplantation</brief_title>
  <acronym>EMiRA</acronym>
  <official_title>The Long-term Effect of Marine n-3 Polyunsaturated Fatty Acid Supplementation on Glomerular Filtration Rate and Development of Fibrosis in the Renal Allograft: a Randomized Double Blind Placebo Controlled Intervention Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Joe Chan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Oslo</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Rikshospitalet University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ullevaal University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Drammen sykehus</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Elverum Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>South-Eastern Norway Regional Health Authority</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Aalborg University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Pronova BioPharma</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Haukeland University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospital of North Norway</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Akershus</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>
      This is a long-term intervention study on the effects of marine n-3 PUFAs in renal&#xD;
      transplantation. Our hypothesis is that patients treated with marine n-3 PUFA supplementation&#xD;
      will have less decline in kidney transplant function compared to patients treated with&#xD;
      placebo.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is designed as a randomized, double blind, placebo controlled, multi-center trial&#xD;
      of 174 renal transplant recipients. Patients will be randomized to oral supplementation of&#xD;
      marine n-3 PUFA 2.5 g / day or control in a 1:1 fashion.&#xD;
&#xD;
      The primary endpoint is change in estimated glomerular filtration rate after 156 weeks in the&#xD;
      treatment group compared with the control group. Secondary endpoints include the following&#xD;
      variables: proteinuria, plasma inflammatory biomarkers, blood pressure, resting heart rate,&#xD;
      fasting serum glucose / HbA1c, lipid and lipoprotein concentrations, number of graft&#xD;
      rejections and graft losses, and number of cardiovascular events and deaths.&#xD;
&#xD;
      Patients from Akershus University Hospital will also participate in a sub-study, where renal&#xD;
      graft biopsies will be performed to assess the degree of fibrosis and chronic allograft&#xD;
      damage index (CADI) and markers of fibrosis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Anticipated">August 31, 2025</completion_date>
  <primary_completion_date type="Anticipated">August 31, 2025</primary_completion_date>
  <phase>Phase 3</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Glomerular filtration rate</measure>
    <time_frame>156 weeks</time_frame>
    <description>Estimated by CKD-EPI equation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proteinuria</measure>
    <time_frame>156 weeks</time_frame>
    <description>ACR and FE-protein</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma fatty acid levels</measure>
    <time_frame>156 weeks</time_frame>
    <description>measured by gas chromatography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma inflammatory biomarkers</measure>
    <time_frame>156 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood pressure</measure>
    <time_frame>156 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Resting heart rate</measure>
    <time_frame>156 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fasting serum glucose / HbA1c</measure>
    <time_frame>156 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lipid and lipoprotein concentrations</measure>
    <time_frame>156 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body mass index</measure>
    <time_frame>156 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate variability</measure>
    <time_frame>156 weeks</time_frame>
    <description>Sub-study, participants from Akershus University Hospital only</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The degree of fibrosis and chronic allograft damage index (CADI) in renal cortical tissue</measure>
    <time_frame>156 weeks</time_frame>
    <description>Sub-study, participants from Akershus University Hospital only</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Markers of fibrosis in renal cortical tissue</measure>
    <time_frame>156 weeks</time_frame>
    <description>Sub-study, participants from Akershus University Hospital only</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fatty acid levels in renal cortical tissue</measure>
    <time_frame>156 weeks</time_frame>
    <description>Sub-study, participants from Akershus University Hospital only</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Adverse events</measure>
    <time_frame>156 weeks</time_frame>
    <description>Incl. number of graft rejections and losses, cardiovascular events and deaths</description>
  </other_outcome>
  <other_outcome>
    <measure>Adverse reactions</measure>
    <time_frame>156 weeks</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">174</enrollment>
  <condition>Kidney Transplantation</condition>
  <arm_group>
    <arm_group_label>Marine n-3 PUFAs</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>3 capsules of Omacor 1000 mg daily, corresponding to a dose of 2.5 g / day of marine n-3 PUFAs (EPA plus DHA).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Corresponding placebo oral capsules with olive oil, three capsules daily.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Omacor</intervention_name>
    <description>As described in &quot;Arms&quot;.</description>
    <arm_group_label>Marine n-3 PUFAs</arm_group_label>
    <other_name>Omega-3 fatty acids</other_name>
    <other_name>EPA</other_name>
    <other_name>DHA</other_name>
    <other_name>Marine n-3 polyunsaturated fatty acids</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo Oral Capsule</intervention_name>
    <description>As described in &quot;Arms&quot;.</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Olive oil</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Renal transplant recipients over 18 years of age.&#xD;
&#xD;
          -  Stable renal graft function, defined as eGFR &gt;30 ml/min at the last 2 visits.&#xD;
&#xD;
          -  6-60 months post-transplantation at randomization.&#xD;
&#xD;
          -  Signed informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women of childbearing potential who are unwilling or unable to use an acceptable&#xD;
             method to avoid pregnancy for the entire study period and for up to 4 weeks after the&#xD;
             last dose of study drug.&#xD;
&#xD;
          -  Women who are pregnant or breastfeeding.&#xD;
&#xD;
          -  Patients who participate in a clinical trial with other investigational drugs.&#xD;
&#xD;
          -  Patients with a history of an allergic reaction or significant sensitivity to fish,&#xD;
             seafood and the study drug Omacor or drugs or dietary supplements similar to the study&#xD;
             drug.&#xD;
&#xD;
          -  Any reason why, in the opinion of the Principal Investigator, the patient should not&#xD;
             participate - E.g. history of repeated non-adherence to prescribed treatment, repeated&#xD;
             non-attendance to clinic visits, cognitive impairment that prevents understanding the&#xD;
             nature of this study, etc.&#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>My Svensson, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>University Hospital, Akershus</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ivar Anders Eide, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>University Hospital, Akershus</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Branimir Draganov, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Ullevaal University Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Joe Chan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Akershus</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Morten Reier-Nilsen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Drammen sykehus</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Tone Granseth, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Elverum Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Nanna von der Lippe, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ullevaal University Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Bård Endre Waldum-Grevbo, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ullevaal University Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Per Olav Rui, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Haukeland University Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Toralf Melsom, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital of North Norway</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Renathe Rismo, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital of North Norway</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Akershus University Hospital</name>
      <address>
        <city>Lørenskog</city>
        <state>Akershus</state>
        <zip>1478</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Drammen Hospital</name>
      <address>
        <city>Drammen</city>
        <state>Buskerud</state>
        <zip>3004</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Elverum Hospital</name>
      <address>
        <city>Elverum</city>
        <state>Hedmark</state>
        <zip>2409</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Haukeland University Hospital</name>
      <address>
        <city>Bergen</city>
        <zip>5021</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ullevaal University Hospital</name>
      <address>
        <city>Oslo</city>
        <zip>0450</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital of North Norway</name>
      <address>
        <city>Tromsø</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>January 10, 2017</study_first_submitted>
  <study_first_submitted_qc>January 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 11, 2017</study_first_posted>
  <last_update_submitted>October 18, 2022</last_update_submitted>
  <last_update_submitted_qc>October 18, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 19, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Akershus</investigator_affiliation>
    <investigator_full_name>Joe Chan</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Kidney transplantation</keyword>
  <keyword>Renal transplantation</keyword>
  <keyword>Omega-3 fatty acids</keyword>
  <keyword>Marine n-3 fatty acids</keyword>
  <keyword>Fatty acids</keyword>
  <keyword>Inflammation</keyword>
  <keyword>Interstitial fibrosis</keyword>
  <keyword>Glomerular filtration rate</keyword>
  <keyword>Renal function</keyword>
  <keyword>Allograft function</keyword>
  <keyword>Proteinuria</keyword>
  <keyword>Blood pressure</keyword>
  <keyword>Heart rate variability</keyword>
  <keyword>Lipids</keyword>
  <keyword>Blood glucose</keyword>
  <keyword>Body mass index</keyword>
  <keyword>Fatty acid composition</keyword>
  <keyword>Gas chromatography</keyword>
  <keyword>Interventional study</keyword>
  <keyword>Allograft biopsy</keyword>
  <keyword>Kidney biopsy</keyword>
  <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/NCT03018041
org study id: 2016/1652 (REK)
secondary id: 2016-003537-18
nct id: NCT03018041
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a long-term intervention study on the effects of marine n-3 PUFAs in renal
      transplantation. Our hypothesis is that patients treated with marine n-3 PUFA supplementation
      will have less decline in kidney transplant function compared to patients treated with
      placebo.
The study is designed as a randomized, double blind, placebo controlled, multi-center trial
      of 174 renal transplant recipients. Patients will be randomized to oral supplementation of
      marine n-3 PUFA 2.5 g / day or control in a 1:1 fashion.

      The primary endpoint is change in estimated glomerular filtration rate after 156 weeks in the
      treatment group compared with the control group. Secondary endpoints include the following
      variables: proteinuria, plasma inflammatory biomarkers, blood pressure, resting heart rate,
      fasting serum glucose / HbA1c, lipid and lipoprotein concentrations, number of graft
      rejections and graft losses, and number of cardiovascular events and deaths.

      Patients from Akershus University Hospital will also participate in a sub-study, where renal
      graft biopsies will be performed to assess the degree of fibrosis and chronic allograft
      damage index (CADI) and markers of fibrosis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Glomerular filtration rate
time frame: 156 weeks
description: Estimated by CKD-EPI equation
measure: Proteinuria
time frame: 156 weeks
description: ACR and FE-protein
measure: Plasma fatty acid levels
time frame: 156 weeks
description: measured by gas chromatography
measure: Plasma inflammatory biomarkers
time frame: 156 weeks
measure: Blood pressure
time frame: 156 weeks
measure: Resting heart rate
time frame: 156 weeks
measure: Fasting serum glucose / HbA1c
time frame: 156 weeks
measure: Lipid and lipoprotein concentrations
time frame: 156 weeks
measure: Body mass index
time frame: 156 weeks
measure: Heart rate variability
time frame: 156 weeks
description: Sub-study, participants from Akershus University Hospital only
measure: The degree of fibrosis and chronic allograft damage index (CADI) in renal cortical tissue
time frame: 156 weeks
description: Sub-study, participants from Akershus University Hospital only
measure: Markers of fibrosis in renal cortical tissue
time frame: 156 weeks
description: Sub-study, participants from Akershus University Hospital only
measure: Fatty acid levels in renal cortical tissue
time frame: 156 weeks
description: Sub-study, participants from Akershus University Hospital only
measure: Adverse events
time frame: 156 weeks
description: Incl. number of graft rejections and losses, cardiovascular events and deaths
measure: Adverse reactions
time frame: 156 weeks
arm group label: Marine n-3 PUFAs
arm group type: Experimental
description: 3 capsules of Omacor 1000 mg daily, corresponding to a dose of 2.5 g / day of marine n-3 PUFAs (EPA plus DHA).
arm group label: Placebo
arm group type: Placebo Comparator
description: Corresponding placebo oral capsules with olive oil, three capsules daily.
intervention type: Drug
intervention name: Omacor
description: As described in "Arms".
arm group label: Marine n-3 PUFAs
other name: Omega-3 fatty acids
other name: EPA
other name: DHA
other name: Marine n-3 polyunsaturated fatty acids
intervention type: Drug
intervention name: Placebo Oral Capsule
description: As described in "Arms".
arm group label: Placebo
other name: Olive oil
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: My Svensson, MD, PhD
role: Study Director
affiliation: University Hospital, Akershus
last name: Ivar Anders Eide, MD, PhD
role: Study Chair
affiliation: University Hospital, Akershus
last name: Branimir Draganov, MD
role: Study Chair
affiliation: Ullevaal University Hospital
last name: Joe Chan, MD
role: Principal Investigator
affiliation: University Hospital, Akershus
last name: Morten Reier-Nilsen, MD
role: Principal Investigator
affiliation: Drammen sykehus
last name: Tone Granseth, MD
role: Principal Investigator
affiliation: Elverum Hospital
last name: Nanna von der Lippe, MD, PhD
role: Principal Investigator
affiliation: Ullevaal University Hospital
last name: Bård Endre Waldum-Grevbo, MD, PhD
role: Principal Investigator
affiliation: Ullevaal University Hospital
last name: Per Olav Rui, MD
role: Principal Investigator
affiliation: Haukeland University Hospital
last name: Toralf Melsom, MD, PhD
role: Principal Investigator
affiliation: University Hospital of North Norway
last name: Renathe Rismo, MD, PhD
role: Principal Investigator
affiliation: University Hospital of North Norway
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Norway
responsible party type: Sponsor-Investigator
investigator affiliation: University Hospital, Akershus
investigator full name: Joe Chan
investigator title: MD
sharing ipd: No