<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/NCT03769298</url>
  </required_header>
  <id_info>
    <org_study_id>2018-0821</org_study_id>
    <secondary_id>A539742</secondary_id>
    <secondary_id>SMPH/SURGERY/TRANSPLANT</secondary_id>
    <secondary_id>Protocol Version 9/9/2020</secondary_id>
    <nct_id>NCT03769298</nct_id>
  </id_info>
  <brief_title>CIRTEN-Simultaneous Pancreas-Kidney Transplant Recipients</brief_title>
  <official_title>Conversion From Immediate Release Tacrolimus to Envarsus XR® in Simultaneous Pancreas-Kidney Recipients: Assessment of Functional, Safety and Quality of Life Outcomes (CIRTEN SPK)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Wisconsin, Madison</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Veloxis Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Wisconsin, Madison</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a Phase II/III, Single-center, Prospective, Open-label, Single Arm Study of 30&#xD;
      Simultaneous Kidney Pancreas recipients who received a transplant at least 3 months, but no&#xD;
      more than 5 years prior, with a history of tremors following transplantation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Accrual objective: Enrollment of 2-3 participants per month and all participants within an 18&#xD;
      month period. With minimum of 1 year follow-up post-conversion, we anticipate the entire&#xD;
      study would be completed within 2 ½ years.&#xD;
&#xD;
      Study design: This is a Phase II/III, Single-center, Prospective, Open-label, Single Arm&#xD;
      Study of 30 Simultaneous Kidney Pancreas recipients who received a transplant at least 3&#xD;
      months, but no more than 5 years prior, with a history of tremors following transplantation.&#xD;
&#xD;
      Study duration: There will be a minimum of 1 year follow-up post-conversion, and it is&#xD;
      expected that the entire study would be completed within 2 ½ years.&#xD;
&#xD;
      Study aims:&#xD;
&#xD;
        -  Determine if EnvarsusXR® reduces tremor severity compared to IR tacrolimus&#xD;
&#xD;
        -  Determine if EnvarsusXR® improves renal function or glycemic control compared to IR&#xD;
           tacrolimus&#xD;
&#xD;
        -  Compare the efficacy of EnvarsusXR® by comparing the outcomes (patient, pancreas graft&#xD;
           and kidney graft survival) of patients treated with Envarsus XR to those of contemporary&#xD;
           and historical controls at our center treated with IR tacrolimus, with the goal of&#xD;
           showing non-inferiority.&#xD;
&#xD;
        -  Compare insulin resistance and insulin sensitivity by defined measures post conversion&#xD;
           between T1D and T2D recipients.&#xD;
&#xD;
      Primary Endpoint:&#xD;
&#xD;
        1. Improvement in patient and physician-assessed degree of tremors based on FTM&#xD;
           (Fahn-Tolosa-Martin Tremor Rating Scale) and QUEST (Quality of Life in Essential Tremor&#xD;
           Questionnaire) scoring tools&#xD;
&#xD;
        2. Scores on Quality of Life in Essential Tremor and Modified Transplant Symptom Occurrence&#xD;
           and Symptom Distress Scale (MTSOSD) Questionnaires&#xD;
&#xD;
      Secondary Endpoints:&#xD;
&#xD;
        1. Renal function - eGFR (estimated glomerular filtration rate) and serum creatinine&#xD;
&#xD;
        2. Glycemic control - AUC by MMTT, fasting BG, fasting C-peptide, calculated&#xD;
           C-peptide/glucose ratio, calculated 20/(fasting Cpeptide x fasting BG) as a measure of&#xD;
           insulin resistance, calculated HOMA-IR (fasting insulin x fasting BG)/22.5 as a measure&#xD;
           of insulin sensitivity/resistance, calculated BETA-2 score to sensitive estimate beta&#xD;
           cell function, and HbA1c.&#xD;
&#xD;
        3. Tacrolimus and Mycophenolate doses as well as TAC and MPA levels&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 27, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>This is a Phase II/III, Single-center, Prospective, Open-label, Single Arm Study of 30 Simultaneous Kidney Pancreas recipients who received a transplant at least 3 months, but no more than 2 years prior, with a history of tremors following transplantation.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in patient and physician-assessed degree of tremors based on Fahn-Tolosa-Marin Tremor Rating Scale</measure>
    <time_frame>Over 6 months</time_frame>
    <description>FTM-TRS will be used as a tool for essential tremor scoring. (0: no tremor, 1: barely perceptible tremor, 2: &lt; 2 cm, 3: 2-4 cm, and 4: &gt; 4 cm).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in patient and physician-assessed degree of tremors based on Quality of Life in Essential Tremor (QUEST) Questionnaire</measure>
    <time_frame>Over 6 months</time_frame>
    <description>QUEST Questionnaire, a scoring tool will be used to measure the quality of life among patients with Essential Tremor. It consists of 30 items which are rated on a five-point scale (score 0-4), corresponding to the frequency (never, rarely, sometimes, frequently, always) with which tremor was perceived to affect a function or to be associated with various feelings and attitudes. A few items (e.g. 'I had to quit my job because of tremor') could only be answered at the extremes (yes/no; true/false), and these were scored either 0 or 4.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Scores on Quality of Life in Essential Tremor Questionnaires</measure>
    <time_frame>Over 6 months</time_frame>
    <description>Use QUEST (Quality of Life in Essential Tremor Questionnaire) scoring tool</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Scores on Modified Transplant Symptom Occurrence and Symptom Distress Scale (MTSOSD) Questionnaire</measure>
    <time_frame>Over 6 months</time_frame>
    <description>MTSOSD Questionnaire scores will be used to assess the presence and distress of side effects associated with the use of immunosuppressive drugs after transplantation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Renal function by eGFR (estimated Glomerular Filtration Rate)</measure>
    <time_frame>Over 6 months</time_frame>
    <description>Change between baseline and post-conversion as measured by eGFR</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Renal function by serum creatinine</measure>
    <time_frame>Over 6 months</time_frame>
    <description>Change between baseline and post-conversion as measured by serum creatinine</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparable or improved glycemic control as measured by mixed meal tolerance test</measure>
    <time_frame>Over 6 months</time_frame>
    <description>Change between baseline and post-conversion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparable or improved glycemic control as measured by HbA1c</measure>
    <time_frame>Over 6 months</time_frame>
    <description>Change between baseline and post-conversion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tacrolimus doses and levels</measure>
    <time_frame>Over 6 months</time_frame>
    <description>Change between baseline and post-conversion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mycophenolate doses and levels</measure>
    <time_frame>Over 6 months</time_frame>
    <description>Change between baseline and post-conversion</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Kidney Pancreas Transplantation</condition>
  <arm_group>
    <arm_group_label>Envarsus XR</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Envarsus XR (extended release) will be administered orally, once-daily, for 6 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Envarsus XR</intervention_name>
    <description>The Envarsus XR® drug will be administered to study participants once daily, orally. The dosage can be 0.75 mg, 1 mg or 4 mg. The tacrolimus whole blood trough concentrations will be monitored and titrate Envarsus XR® dosage to achieve target whole blood trough concentration.</description>
    <arm_group_label>Envarsus XR</arm_group_label>
    <other_name>tacrolimus</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult, 18-70 years of age&#xD;
&#xD;
          -  Participant must be able to understand and provide consent&#xD;
&#xD;
          -  History of Diabetes Type 1 or Insulin-Dependent Diabetes Type 2 with Chronic Kidney&#xD;
             Disease (CKD)&#xD;
&#xD;
          -  Recipient of a Simultaneous Pancreas Kidney (SPK) transplant, 3- 60 months prior to&#xD;
             screening, per Principal Investigator's discretion.&#xD;
&#xD;
          -  Have a history of tremors following transplantation&#xD;
&#xD;
          -  Stable pancreas allograft function as evidenced by no requirement of exogenous insulin&#xD;
             or oral anti-diabetic agents and stable pancreatic enzymes&#xD;
&#xD;
          -  Stable kidney allograft function&#xD;
&#xD;
          -  Currently taking Immediate-Release (IR) tacrolimus&#xD;
&#xD;
          -  Women of child-bearing potential (WOCP) must have a negative pregnancy test at the&#xD;
             time of study entry&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Currently maintained on an extended-release tacrolimus immunosuppressive regimen&#xD;
&#xD;
          -  Previous history of tremors prior to transplantation&#xD;
&#xD;
          -  Solitary pancreas transplant recipients&#xD;
&#xD;
          -  History of solid organ transplant other than a kidney or pancreas&#xD;
&#xD;
          -  Uncontrolled concomitant infection at the discretion of the investigator&#xD;
&#xD;
          -  Presence of Donor Specific Antibodies&#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>Jon S Odorico, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Wisconsin, Madison</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jon S Odorico, MD</last_name>
    <phone>6082639903</phone>
    <email>jon@surgery.wisc.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Wisconsin</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53792</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jon S Odorico, MD</last_name>
      <phone>608-263-4768</phone>
      <email>jon@surgery.wisc.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206406Orig1_toc.cfm</url>
    <description>U.S. Food and Drug Administration. Drug Approval Package.</description>
  </link>
  <link>
    <url>https://www.asn-online.org/education/kidneyweek/archives/</url>
    <description>5. West-Thielke P, Brennan D, Stevens D. Pharmacokinetics of once-daily Envarsus XR in diabetic vs. non-diabetic kidney transplant recipients: a pooled subgroup analysis. [abstract] Kidney Week. Nov 2016, Chicago IL.</description>
  </link>
  <reference>
    <citation>Langone A, Steinberg SM, Gedaly R, Chan LK, Shah T, Sethi KD, Nigro V, Morgan JC; STRATO Investigators. Switching STudy of Kidney TRansplant PAtients with Tremor to LCP-TacrO (STRATO): an open-label, multicenter, prospective phase 3b study. Clin Transplant. 2015 Sep;29(9):796-805. doi: 10.1111/ctr.12581. Epub 2015 Aug 6.</citation>
    <PMID>26113208</PMID>
  </reference>
  <reference>
    <citation>Baraldo M. Meltdose Tacrolimus Pharmacokinetics. Transplant Proc. 2016 Mar;48(2):420-3. doi: 10.1016/j.transproceed.2016.02.002.</citation>
    <PMID>27109969</PMID>
  </reference>
  <reference>
    <citation>Kerstenetzky L, Descourouez JL, Jorgenson MR, Felix DC, Mandelbrot DA, Redfield RR, Odorico JS. A Single-Center Experience With Tacrolimus LCP (Envarsus XR) in Pancreas Transplant Recipients. Ann Pharmacother. 2018 Apr;52(4):392-396. doi: 10.1177/1060028017749076. Epub 2017 Dec 14. No abstract available.</citation>
    <PMID>29241340</PMID>
  </reference>
  <reference>
    <citation>Stacy MA, Elble RJ, Ondo WG, Wu SC, Hulihan J; TRS study group. Assessment of interrater and intrarater reliability of the Fahn-Tolosa-Marin Tremor Rating Scale in essential tremor. Mov Disord. 2007 Apr 30;22(6):833-8. doi: 10.1002/mds.21412.</citation>
    <PMID>17343274</PMID>
  </reference>
  <reference>
    <citation>Ohkura T, Shiochi H, Fujioka Y, Sumi K, Yamamoto N, Matsuzawa K, Izawa S, Kinoshita H, Ohkura H, Kato M, Taniguchi S, Yamamoto K. 20/(fasting C-peptide x fasting plasma glucose) is a simple and effective index of insulin resistance in patients with type 2 diabetes mellitus: a preliminary report. Cardiovasc Diabetol. 2013 Jan 22;12:21. doi: 10.1186/1475-2840-12-21.</citation>
    <PMID>23339473</PMID>
  </reference>
  <reference>
    <citation>Gutch M, Kumar S, Razi SM, Gupta KK, Gupta A. Assessment of insulin sensitivity/resistance. Indian J Endocrinol Metab. 2015 Jan-Feb;19(1):160-4. doi: 10.4103/2230-8210.146874.</citation>
    <PMID>25593845</PMID>
  </reference>
  <reference>
    <citation>Forbes S, Oram RA, Smith A, Lam A, Olateju T, Imes S, Malcolm AJ, Shapiro AM, Senior PA. Validation of the BETA-2 Score: An Improved Tool to Estimate Beta Cell Function After Clinical Islet Transplantation Using a Single Fasting Blood Sample. Am J Transplant. 2016 Sep;16(9):2704-13. doi: 10.1111/ajt.13807. Epub 2016 Apr 21.</citation>
    <PMID>27017888</PMID>
  </reference>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>November 16, 2018</study_first_submitted>
  <study_first_submitted_qc>December 5, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 7, 2018</study_first_posted>
  <last_update_submitted>March 28, 2023</last_update_submitted>
  <last_update_submitted_qc>March 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 29, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Tremors</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tacrolimus</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/NCT03769298
org study id: 2018-0821
secondary id: A539742
secondary id: SMPH/SURGERY/TRANSPLANT
secondary id: Protocol Version 9/9/2020
nct id: NCT03769298
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
This is a Phase II/III, Single-center, Prospective, Open-label, Single Arm Study of 30
      Simultaneous Kidney Pancreas recipients who received a transplant at least 3 months, but no
      more than 5 years prior, with a history of tremors following transplantation.
Accrual objective: Enrollment of 2-3 participants per month and all participants within an 18
      month period. With minimum of 1 year follow-up post-conversion, we anticipate the entire
      study would be completed within 2 ½ years.

      Study design: This is a Phase II/III, Single-center, Prospective, Open-label, Single Arm
      Study of 30 Simultaneous Kidney Pancreas recipients who received a transplant at least 3
      months, but no more than 5 years prior, with a history of tremors following transplantation.

      Study duration: There will be a minimum of 1 year follow-up post-conversion, and it is
      expected that the entire study would be completed within 2 ½ years.

      Study aims:

        -  Determine if EnvarsusXR® reduces tremor severity compared to IR tacrolimus

        -  Determine if EnvarsusXR® improves renal function or glycemic control compared to IR
           tacrolimus

        -  Compare the efficacy of EnvarsusXR® by comparing the outcomes (patient, pancreas graft
           and kidney graft survival) of patients treated with Envarsus XR to those of contemporary
           and historical controls at our center treated with IR tacrolimus, with the goal of
           showing non-inferiority.

        -  Compare insulin resistance and insulin sensitivity by defined measures post conversion
           between T1D and T2D recipients.

      Primary Endpoint:

        1. Improvement in patient and physician-assessed degree of tremors based on FTM
           (Fahn-Tolosa-Martin Tremor Rating Scale) and QUEST (Quality of Life in Essential Tremor
           Questionnaire) scoring tools

        2. Scores on Quality of Life in Essential Tremor and Modified Transplant Symptom Occurrence
           and Symptom Distress Scale (MTSOSD) Questionnaires

      Secondary Endpoints:

        1. Renal function - eGFR (estimated glomerular filtration rate) and serum creatinine

        2. Glycemic control - AUC by MMTT, fasting BG, fasting C-peptide, calculated
           C-peptide/glucose ratio, calculated 20/(fasting Cpeptide x fasting BG) as a measure of
           insulin resistance, calculated HOMA-IR (fasting insulin x fasting BG)/22.5 as a measure
           of insulin sensitivity/resistance, calculated BETA-2 score to sensitive estimate beta
           cell function, and HbA1c.

        3. Tacrolimus and Mycophenolate doses as well as TAC and MPA levels
allocation: N/A
intervention model: Single Group Assignment
intervention model description: This is a Phase II/III, Single-center, Prospective, Open-label, Single Arm Study of 30 Simultaneous Kidney Pancreas recipients who received a transplant at least 3 months, but no more than 2 years prior, with a history of tremors following transplantation.
primary purpose: Treatment
masking: None (Open Label)
measure: Change in patient and physician-assessed degree of tremors based on Fahn-Tolosa-Marin Tremor Rating Scale
time frame: Over 6 months
description: FTM-TRS will be used as a tool for essential tremor scoring. (0: no tremor, 1: barely perceptible tremor, 2: < 2 cm, 3: 2-4 cm, and 4: > 4 cm).
measure: Change in patient and physician-assessed degree of tremors based on Quality of Life in Essential Tremor (QUEST) Questionnaire
time frame: Over 6 months
description: QUEST Questionnaire, a scoring tool will be used to measure the quality of life among patients with Essential Tremor. It consists of 30 items which are rated on a five-point scale (score 0-4), corresponding to the frequency (never, rarely, sometimes, frequently, always) with which tremor was perceived to affect a function or to be associated with various feelings and attitudes. A few items (e.g. 'I had to quit my job because of tremor') could only be answered at the extremes (yes/no; true/false), and these were scored either 0 or 4.
measure: Scores on Quality of Life in Essential Tremor Questionnaires
time frame: Over 6 months
description: Use QUEST (Quality of Life in Essential Tremor Questionnaire) scoring tool
measure: Scores on Modified Transplant Symptom Occurrence and Symptom Distress Scale (MTSOSD) Questionnaire
time frame: Over 6 months
description: MTSOSD Questionnaire scores will be used to assess the presence and distress of side effects associated with the use of immunosuppressive drugs after transplantation.
measure: Renal function by eGFR (estimated Glomerular Filtration Rate)
time frame: Over 6 months
description: Change between baseline and post-conversion as measured by eGFR
measure: Renal function by serum creatinine
time frame: Over 6 months
description: Change between baseline and post-conversion as measured by serum creatinine
measure: Comparable or improved glycemic control as measured by mixed meal tolerance test
time frame: Over 6 months
description: Change between baseline and post-conversion
measure: Comparable or improved glycemic control as measured by HbA1c
time frame: Over 6 months
description: Change between baseline and post-conversion
measure: Tacrolimus doses and levels
time frame: Over 6 months
description: Change between baseline and post-conversion
measure: Mycophenolate doses and levels
time frame: Over 6 months
description: Change between baseline and post-conversion
arm group label: Envarsus XR
arm group type: Experimental
description: Envarsus XR (extended release) will be administered orally, once-daily, for 6 months.
intervention type: Drug
intervention name: Envarsus XR
description: The Envarsus XR® drug will be administered to study participants once daily, orally. The dosage can be 0.75 mg, 1 mg or 4 mg. The tacrolimus whole blood trough concentrations will be monitored and titrate Envarsus XR® dosage to achieve target whole blood trough concentration.
arm group label: Envarsus XR
other name: tacrolimus
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Jon S Odorico, MD
role: Principal Investigator
affiliation: University of Wisconsin, Madison
last name: Jon S Odorico, MD
phone: 6082639903
email: jon@surgery.wisc.edu
facility: 
status: Recruiting
contact: 
country: United States
url: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206406Orig1_toc.cfm
description: U.S. Food and Drug Administration. Drug Approval Package.
url: https://www.asn-online.org/education/kidneyweek/archives/
description: 5. West-Thielke P, Brennan D, Stevens D. Pharmacokinetics of once-daily Envarsus XR in diabetic vs. non-diabetic kidney transplant recipients: a pooled subgroup analysis. [abstract] Kidney Week. Nov 2016, Chicago IL.
citation: Langone A, Steinberg SM, Gedaly R, Chan LK, Shah T, Sethi KD, Nigro V, Morgan JC; STRATO Investigators. Switching STudy of Kidney TRansplant PAtients with Tremor to LCP-TacrO (STRATO): an open-label, multicenter, prospective phase 3b study. Clin Transplant. 2015 Sep;29(9):796-805. doi: 10.1111/ctr.12581. Epub 2015 Aug 6.
PMID: 26113208
citation: Baraldo M. Meltdose Tacrolimus Pharmacokinetics. Transplant Proc. 2016 Mar;48(2):420-3. doi: 10.1016/j.transproceed.2016.02.002.
PMID: 27109969
citation: Kerstenetzky L, Descourouez JL, Jorgenson MR, Felix DC, Mandelbrot DA, Redfield RR, Odorico JS. A Single-Center Experience With Tacrolimus LCP (Envarsus XR) in Pancreas Transplant Recipients. Ann Pharmacother. 2018 Apr;52(4):392-396. doi: 10.1177/1060028017749076. Epub 2017 Dec 14. No abstract available.
PMID: 29241340
citation: Stacy MA, Elble RJ, Ondo WG, Wu SC, Hulihan J; TRS study group. Assessment of interrater and intrarater reliability of the Fahn-Tolosa-Marin Tremor Rating Scale in essential tremor. Mov Disord. 2007 Apr 30;22(6):833-8. doi: 10.1002/mds.21412.
PMID: 17343274
citation: Ohkura T, Shiochi H, Fujioka Y, Sumi K, Yamamoto N, Matsuzawa K, Izawa S, Kinoshita H, Ohkura H, Kato M, Taniguchi S, Yamamoto K. 20/(fasting C-peptide x fasting plasma glucose) is a simple and effective index of insulin resistance in patients with type 2 diabetes mellitus: a preliminary report. Cardiovasc Diabetol. 2013 Jan 22;12:21. doi: 10.1186/1475-2840-12-21.
PMID: 23339473
citation: Gutch M, Kumar S, Razi SM, Gupta KK, Gupta A. Assessment of insulin sensitivity/resistance. Indian J Endocrinol Metab. 2015 Jan-Feb;19(1):160-4. doi: 10.4103/2230-8210.146874.
PMID: 25593845
citation: Forbes S, Oram RA, Smith A, Lam A, Olateju T, Imes S, Malcolm AJ, Shapiro AM, Senior PA. Validation of the BETA-2 Score: An Improved Tool to Estimate Beta Cell Function After Clinical Islet Transplantation Using a Single Fasting Blood Sample. Am J Transplant. 2016 Sep;16(9):2704-13. doi: 10.1111/ajt.13807. Epub 2016 Apr 21.
PMID: 27017888
responsible party type: Sponsor
mesh term: Tacrolimus
sharing ipd: No