<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/NCT01694160</url>
  </required_header>
  <id_info>
    <org_study_id>2012/107 D</org_study_id>
    <secondary_id>2012-000429-32</secondary_id>
    <nct_id>NCT01694160</nct_id>
  </id_info>
  <brief_title>Oral Paricalcitol in Renal Transplant Recipients for Reducing Albuminuria</brief_title>
  <official_title>Consultant in Nephrology. MD., Ph.D.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oslo University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Oslo University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main objective of this study is to examine if paricalcitol may reduce progression of&#xD;
      graft fibrosis and proteinuria in kidney transplant patients. Cyclosporine and tacrolimus&#xD;
      have a detrimental long-term effect by inducing graft fibrosis. About 50% of graft losses are&#xD;
      related to interstitial fibrosis. Paricalcitol is a vitamin D receptor activator indicated&#xD;
      for treatment of secondary hyperparathyroidism. Paricalcitol is known to exert an&#xD;
      anti-inflammatory and antifibrotic and attenuate cyclosporine-induced fibrosis. Paricalcitol&#xD;
      is also shown to be renoprotective by reducing proteinuria. No randomized controlled trials&#xD;
      with paricalcitol are performed in renal transplant patients examining the effect on&#xD;
      proteinuria and graft fibrosis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      77 randomized, 37 paricalcitol, 40 no treatment&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">January 2015</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in albumin/creatinine ratio from baseline to end of study.</measure>
    <time_frame>1 year</time_frame>
    <description>Albumin will be measured in spot urine as albumin/creatinine ratio in mg/mmol. Assuming a type 1 error of 5% and at type II error of 20 %, with a clinically relevant difference in 3.5 mg/mmol from a baseline value of 15.0 + 10 mg/mmol the estimated number of patients in each arm should be 65, assuming a correlation between start and end value of 0.5.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">77</enrollment>
  <condition>Proteinuria</condition>
  <arm_group>
    <arm_group_label>Paricalcitol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Paricalcitol 2 ug/daily for 48 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>no intervention</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Paricalcitol</intervention_name>
    <description>Zemplar (paricalcitol) 2ug daily, oral intake</description>
    <arm_group_label>Paricalcitol</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  kidney transplant patients&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previously transplanted&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hallvard Holdaas, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Oslo University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Renal Section, Oslo University Hospital, Rikshospitalet</name>
      <address>
        <city>Oslo</city>
        <zip>0424</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>March 2016</verification_date>
  <study_first_submitted>September 23, 2012</study_first_submitted>
  <study_first_submitted_qc>September 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 27, 2012</study_first_posted>
  <last_update_submitted>March 29, 2016</last_update_submitted>
  <last_update_submitted_qc>March 29, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 30, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Oslo University Hospital</investigator_affiliation>
    <investigator_full_name>Hallvard Holdaas</investigator_full_name>
    <investigator_title>Consultant Nephrology</investigator_title>
  </responsible_party>
  <keyword>kidney transplant patients</keyword>
  <keyword>Albuminuria</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Proteinuria</mesh_term>
    <mesh_term>Albuminuria</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Yes</ipd_description>
  </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/NCT01694160
org study id: 2012/107 D
secondary id: 2012-000429-32
nct id: NCT01694160
lead sponsor: 
has dmc: Yes
The main objective of this study is to examine if paricalcitol may reduce progression of
      graft fibrosis and proteinuria in kidney transplant patients. Cyclosporine and tacrolimus
      have a detrimental long-term effect by inducing graft fibrosis. About 50% of graft losses are
      related to interstitial fibrosis. Paricalcitol is a vitamin D receptor activator indicated
      for treatment of secondary hyperparathyroidism. Paricalcitol is known to exert an
      anti-inflammatory and antifibrotic and attenuate cyclosporine-induced fibrosis. Paricalcitol
      is also shown to be renoprotective by reducing proteinuria. No randomized controlled trials
      with paricalcitol are performed in renal transplant patients examining the effect on
      proteinuria and graft fibrosis.
77 randomized, 37 paricalcitol, 40 no treatment
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in albumin/creatinine ratio from baseline to end of study.
time frame: 1 year
description: Albumin will be measured in spot urine as albumin/creatinine ratio in mg/mmol. Assuming a type 1 error of 5% and at type II error of 20 %, with a clinically relevant difference in 3.5 mg/mmol from a baseline value of 15.0 + 10 mg/mmol the estimated number of patients in each arm should be 65, assuming a correlation between start and end value of 0.5.
arm group label: Paricalcitol
arm group type: Experimental
description: Paricalcitol 2 ug/daily for 48 weeks
arm group label: no intervention
arm group type: No Intervention
intervention type: Drug
intervention name: Paricalcitol
description: Zemplar (paricalcitol) 2ug daily, oral intake
arm group label: Paricalcitol
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Hallvard Holdaas, MD, PhD
role: Principal Investigator
affiliation: Oslo University Hospital
facility: 
country: Norway
responsible party type: Principal Investigator
investigator affiliation: Oslo University Hospital
investigator full name: Hallvard Holdaas
investigator title: Consultant Nephrology
mesh term: Proteinuria
mesh term: Albuminuria
sharing ipd: No
ipd description: Yes