<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/NCT04417725</url>
  </required_header>
  <id_info>
    <org_study_id>1245.217</org_study_id>
    <nct_id>NCT04417725</nct_id>
  </id_info>
  <brief_title>Burden of Chronic Kidney Disease (CKD), Type 2 Diabetes Mellitus (T2DM), and Comorbid T2DM/CKD in Alberta, Canada</brief_title>
  <official_title>Burden of Disease of Chronic Kidney Disease (CKD), Type 2 Diabetes Mellitus (T2DM), and Comorbid T2DM/CKD in Alberta, Canada: A Non-interventional Study Using Administrative Health Data</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medlior Health Outcomes Research Ltd</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medlior Health Outcomes Research Ltd</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>
      The purpose of the research study is to describe the burden of disease among three different&#xD;
      cohorts of patients: (1) patients diagnosed with CKD, (2) those with T2DM; and (3) those with&#xD;
      T2DM and comorbid CKD.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">April 1, 2008</start_date>
  <completion_date type="Anticipated">August 31, 2022</completion_date>
  <primary_completion_date type="Actual">March 31, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence and prevalence</measure>
    <time_frame>2010 to 2018 fiscal years</time_frame>
    <description>Incidence and prevalence of CKD (by stage), T2DM, and comorbid T2DM/CKD, including 1-, 4-, and 5-year period prevalence and incidence</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Comorbidity and complication profiles and rates</measure>
    <time_frame>2010 to 2019 fiscal years</time_frame>
    <description>For all three cohorts, comorbidities and complications of interest include:&#xD;
Diabetic: hypoglycemia, lower limb amputations, diabetic ketoacidosis&#xD;
Renal: acute kidney injury, acute renal failure, anemia, urogenital tract infections, albuminuria, hematuria, fast estimated glomerular filtration rate decline, CKD progression, continuous renal replacement therapy, dialysis initiation&#xD;
Cardiovascular: CV events (atrial fibrillation, coronary artery disease, chronic heart failure, hypertension, myocardial infarction, hospitalization for heart failure (specific and broad), peripheral artery disease, stroke/transient ischemic attack (TIA)), CV hospitalization, CV mortality&#xD;
Other: fractures and all-cause mortality&#xD;
Any event: Composite outcome to capture any of the above&#xD;
For the CKD cohort, results will also be stratified by T2DM status. Comorbidity/complication rates between the T2DM and T2DM/CKD comorbid populations will be compared.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Factors that influence the progression of CKD in patients</measure>
    <time_frame>2010 to 2019 fiscal years</time_frame>
    <description>Logistic regression model to assess association of variables of interest (age, sex, health region, comorbidities (Charlson Comorbidity Index as well as conditions in outcome 2), ACR, HbA1c, medication use. This will be performed for all patients with CKD and stratified by T2DM status.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Healthcare resource use (HCRU) and associated costs for CKD patients</measure>
    <time_frame>2010 to 2019 fiscal years</time_frame>
    <description>HCRU include: inpatient hospitalizations, hospital length of stay, emergency department visits, general practitioner and specialist visits.&#xD;
Costs include: hospital costs, emergency department costs, physician costs, medication costs.&#xD;
This will be performed for all patients with CKD and stratified by T2DM status.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stage-to-stage progression of CKD across the follow-up years in patients with CKD</measure>
    <time_frame>2010 to 2019 fiscal years</time_frame>
    <description>This will be performed for all patients with CKD and stratified by T2DM status.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment patterns</measure>
    <time_frame>2010 to 2019 fiscal years</time_frame>
    <description>Treatment patterns by year for all three cohorts&#xD;
Drug treatment patterns in patients with T2DM and comorbid CKD versus current guidelines,&#xD;
Treatment patterns for the CKD cohort will also be stratified by T2DM status.</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">400000</enrollment>
  <condition>Chronic Kidney Diseases</condition>
  <condition>Type 2 Diabetes</condition>
  <arm_group>
    <arm_group_label>Chronic kidney disease</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Type 2 diabetes mellitus</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Comorbid type 2 diabetes mellitus and chronic kidney disease</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with CKD will be defined using a published algorithm based on ICD-9-CM/ICD-10-CA&#xD;
        diagnostic codes and eGFR/albuminuria laboratory test values.&#xD;
&#xD;
        Patients with T2DM will be defined using a published algorithm based on ICD-9-CM/ICD-10-CA&#xD;
        diagnostic codes.&#xD;
&#xD;
        Patients with comorbid T2DM/CKD will be identified among patients identified with prevalent&#xD;
        T2DM. CKD comorbidity will be defined as identified CKD within the two years prior or any&#xD;
        time after the T2DM index date.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria (either of the following):&#xD;
&#xD;
          -  Chronic kidney disease identified using laboratory test and health administrative data&#xD;
&#xD;
          -  Type 2 diabetes mellitus identified using health administrative data&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt; 18 years&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>June 2, 2020</study_first_submitted>
  <study_first_submitted_qc>June 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <last_update_submitted>April 6, 2022</last_update_submitted>
  <last_update_submitted_qc>April 6, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 8, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medlior Health Outcomes Research Ltd</investigator_affiliation>
    <investigator_full_name>Tara Cowling</investigator_full_name>
    <investigator_title>Director and Managing Principal</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</mesh_term>
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_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/NCT04417725
org study id: 1245.217
nct id: NCT04417725
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of the research study is to describe the burden of disease among three different
      cohorts of patients: (1) patients diagnosed with CKD, (2) those with T2DM; and (3) those with
      T2DM and comorbid CKD.
observational model: Cohort
time perspective: Retrospective
measure: Incidence and prevalence
time frame: 2010 to 2018 fiscal years
description: Incidence and prevalence of CKD (by stage), T2DM, and comorbid T2DM/CKD, including 1-, 4-, and 5-year period prevalence and incidence
measure: Comorbidity and complication profiles and rates
time frame: 2010 to 2019 fiscal years
description: For all three cohorts, comorbidities and complications of interest include:
Diabetic: hypoglycemia, lower limb amputations, diabetic ketoacidosis
Renal: acute kidney injury, acute renal failure, anemia, urogenital tract infections, albuminuria, hematuria, fast estimated glomerular filtration rate decline, CKD progression, continuous renal replacement therapy, dialysis initiation
Cardiovascular: CV events (atrial fibrillation, coronary artery disease, chronic heart failure, hypertension, myocardial infarction, hospitalization for heart failure (specific and broad), peripheral artery disease, stroke/transient ischemic attack (TIA)), CV hospitalization, CV mortality
Other: fractures and all-cause mortality
Any event: Composite outcome to capture any of the above
For the CKD cohort, results will also be stratified by T2DM status. Comorbidity/complication rates between the T2DM and T2DM/CKD comorbid populations will be compared.
measure: Factors that influence the progression of CKD in patients
time frame: 2010 to 2019 fiscal years
description: Logistic regression model to assess association of variables of interest (age, sex, health region, comorbidities (Charlson Comorbidity Index as well as conditions in outcome 2), ACR, HbA1c, medication use. This will be performed for all patients with CKD and stratified by T2DM status.
measure: Healthcare resource use (HCRU) and associated costs for CKD patients
time frame: 2010 to 2019 fiscal years
description: HCRU include: inpatient hospitalizations, hospital length of stay, emergency department visits, general practitioner and specialist visits.
Costs include: hospital costs, emergency department costs, physician costs, medication costs.
This will be performed for all patients with CKD and stratified by T2DM status.
measure: Stage-to-stage progression of CKD across the follow-up years in patients with CKD
time frame: 2010 to 2019 fiscal years
description: This will be performed for all patients with CKD and stratified by T2DM status.
measure: Treatment patterns
time frame: 2010 to 2019 fiscal years
description: Treatment patterns by year for all three cohorts
Drug treatment patterns in patients with T2DM and comorbid CKD versus current guidelines,
Treatment patterns for the CKD cohort will also be stratified by T2DM status.
arm group label: Chronic kidney disease
arm group label: Type 2 diabetes mellitus
arm group label: Comorbid type 2 diabetes mellitus and chronic kidney disease
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Medlior Health Outcomes Research Ltd
investigator full name: Tara Cowling
investigator title: Director and Managing Principal
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2