<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/NCT04445181</url>
  </required_header>
  <id_info>
    <org_study_id>21190</org_study_id>
    <nct_id>NCT04445181</nct_id>
  </id_info>
  <brief_title>A Study Using the LMC Diabetes Registry to Learn More About Chronic Kidney Disease (CKD) in Canadian Patients With Type 2 Diabetes (T2D)</brief_title>
  <official_title>Canadian REgistry of Chronic Kidney Disease in Diabetes Outcomes (CREDO) Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bayer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bayer</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>
      In people with type 2 diabetes (T2D), the body does not make enough of a hormone called&#xD;
      insulin or does not use insulin well. This results in high blood sugar levels.&#xD;
&#xD;
      People with T2D are at a higher risk of having a condition called chronic kidney disease&#xD;
      (CKD). In people with CKD, the kidneys become damaged and do not work as they should. People&#xD;
      with CKD can have trouble breathing and often have swelling in their arms and legs, and high&#xD;
      blood pressure.&#xD;
&#xD;
      People who have CKD and T2D are more likely to have other medical problems, such as heart&#xD;
      disease.&#xD;
&#xD;
      There are many treatments available to patients who have CKD and T2D. But, researchers need&#xD;
      more information about how doctors in Canada are deciding which treatment to give these&#xD;
      patients.&#xD;
&#xD;
      In this study, the researchers will review health information from men and women with T2D who&#xD;
      visited a doctor in 2019 and had check-ups for at least 6 months. The health information will&#xD;
      be taken from a Canadian registry (or database) owned by LMC Diabetes &amp; Endocrinology. The&#xD;
      registry contains information from people that went to an LMC clinic. In this study, the&#xD;
      researchers will learn how many of these people had T2D and CKD. They will learn the&#xD;
      treatments these people received, and if they had other related medical problems. The&#xD;
      researchers will also use surveys to ask the doctors about why they chose certain treatments.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Actual">November 23, 2020</completion_date>
  <primary_completion_date type="Actual">November 23, 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>Proportion of patients with CKD in a large T2D population</measure>
    <time_frame>Retrospectively analysis between January 1, 2019 and December 31, 2019</time_frame>
    <description>The data will be retrieved from the LMC Diabetes Registry, a Pan-Canadian registry of diabetes community-based specialist practices and used to develop a renal registry to investigate the primary objectives of the study</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients using the different therapies</measure>
    <time_frame>Retrospectively analysis between January 1, 2019 and December 31, 2019</time_frame>
    <description>The therapies are: ACEi, ARBs, ACEi/ARBs, MRAs, GLP-1 RA and SGLT2i</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients with stage 1 CKD with moderate or greater albuminuria, stage 2 CKD with moderate or greater albuminuria, stage 3a CKD, stage 3b CKD, stage 4 CKD and stage 5 CKD in accordance with Canadian clinical practice guidelines</measure>
    <time_frame>Retrospectively analysis between January 1, 2019 and December 31, 2019</time_frame>
    <description>Stage 1 CKD: eGFR (estimated glomerular filtration rate) ≥ 90 ml/min/1.73 m^2 Stage 2 CKD: eGFR between 60-89 ml/min/1.73 m^2 Stage 3a CKD: eGFR between 45-59 ml/min/1.73 m^2 Stage 3b CKD: eGFR between 30-44 ml/min/1.73 m^2 Stage 4 CKD: eGFR between 15-29 ml/min/1.73 m^2 Stage 5 CKD: eGFR &lt;15 ml/min/1.73 m^2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients with microalbuminuria and macroalbuminuria, in accordance with Canadian clinical practice guidelines</measure>
    <time_frame>Retrospectively analysis between January 1, 2019 and December 31, 2019</time_frame>
    <description>Microalbuminuria: uACR (urine albumin-to-creatinine ratio) 2-20 mg/mmol Macroalbuminuria: uACR &gt; 20 mg/mmol</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients within each albuminuria category (A1, A2 or A3), in accordance with KDIGO clinical practice guidelines</measure>
    <time_frame>Retrospectively analysis between January 1, 2019 and December 31, 2019</time_frame>
    <description>KDIGO = Kidney Disease: Improving Global Outcomes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Laboratory values for patients using either no therapy or using a therapy for ≥ 6 months</measure>
    <time_frame>Retrospectively analysis between January 1, 2019 and December 31, 2019</time_frame>
    <description>Laboratory values including glucose, glycated hemoglobin (HbA1c), lipids, creatinine, electrolytes, eGFR, and uACR</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients with different comorbidities</measure>
    <time_frame>Retrospectively analysis between January 1, 2019 and December 31, 2019</time_frame>
    <description>Comorbidities like hypertension, dyslipidemia, microvascular disease, macrovascular disease</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of healthcare provider prescriptions of RAS therapies (ACEi/ARB) used to treat hypertension, heart failure, coronary artery disease, CKD, or other condition</measure>
    <time_frame>On the day of healthcare provider completes a questionnaire</time_frame>
    <description>RAS: renin angiotensin system ACEi: angiotensin converting enzyme inhibitors ARB: angiotensin receptor blocker&#xD;
Healthcare providers will complete a questionnaire to determine their rationale for use of common therapies for CKD in T2D</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of healthcare provider prescriptions of GLP-1 RA used to treat glycemia management, hypertension, heart failure, coronary artery disease, CKD or other condition</measure>
    <time_frame>On the day of healthcare provider completes a questionnaire</time_frame>
    <description>GLP-1 RA: glucagon-like peptide-1 receptor agonist&#xD;
Healthcare providers will complete a questionnaire to determine their rationale for use of common therapies for CKD in T2D</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of healthcare provider prescriptions of MRAs used to treat hypertension, heart failure, coronary artery disease, CKD or other condition</measure>
    <time_frame>On the day of healthcare provider completes a questionnaire</time_frame>
    <description>MRAs: mineralocorticoid receptor antagonists&#xD;
Healthcare providers will complete a questionnaire to determine their rationale for use of common therapies for CKD in T2D</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of healthcare provider prescriptions of SGLT2i used to treat glycemia management, hypertension, heart failure, coronary artery disease, CKD or other condition</measure>
    <time_frame>On the day of healthcare provider completes a questionnaire</time_frame>
    <description>SGLT2i: sodium-glucose co-transporter-2 inhibitors&#xD;
Healthcare providers will complete a questionnaire to determine their rationale for use of common therapies for CKD in T2D</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">14873</enrollment>
  <condition>Chronic Kidney Disease in Type 2 Diabetes</condition>
  <arm_group>
    <arm_group_label>Patients with T2D</arm_group_label>
    <description>Active patients (defined as patients seen by an LMC endocrinologist between January 1, 2019 and December 31, 2019) with T2D (Type 2 Diabetes). Among the patients with T2D, those identified with CKD will be included in the renal registry.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthcare providers</arm_group_label>
    <description>Healthcare providers caring for patients with CKD and T2D.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>The physician's prescription in routine clinical practice</intervention_name>
    <description>This is an Observational study that will not involve prescription of the drugs.</description>
    <arm_group_label>Patients with T2D</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study population will include active LMC patients with T2D. This population will be&#xD;
        used to determine the prevalence of CKD in patients with T2D. Patients identified with T2D&#xD;
        and CKD will form the cohort for all subsequent analysis.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of T2D as captured in the LMC EMR system&#xD;
&#xD;
          -  Assessed by an LMC endocrinologist between January 1, 2019 and December 31, 2019&#xD;
&#xD;
          -  Followed by an LMC endocrinologist for ≥ 6 months prior to inclusion in the cohort&#xD;
&#xD;
          -  Informed consent to use patient medical record data for research purposes was provided&#xD;
&#xD;
        Among patients who meet the inclusion criteria, estimated glomerular filtration rate (eGFR)&#xD;
        ≤ 60 ml/min/1.73 m^2 and/or urine albumin-to-creatinine ratio (uACR) ≥ 2 mg/mmol will be&#xD;
        used to identify the cohort of patients with T2D and CKD&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Any patients with documented non-diabetic etiology for renal disease will be excluded&#xD;
        from the numerator (number of patients with CKD and T2D) when determining the primary&#xD;
        endpoint&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>A Database</name>
      <address>
        <city>A Database</city>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <link>
    <url>http://clinicaltrials.bayer.com/</url>
    <description>Click here to find results for studies related to Bayer products</description>
  </link>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>June 21, 2020</study_first_submitted>
  <study_first_submitted_qc>June 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 24, 2020</study_first_posted>
  <last_update_submitted>September 28, 2021</last_update_submitted>
  <last_update_submitted_qc>September 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 5, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA &quot;Principles for responsible clinical trial data sharing&quot;. This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.</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/NCT04445181
org study id: 21190
nct id: NCT04445181
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In people with type 2 diabetes (T2D), the body does not make enough of a hormone called
      insulin or does not use insulin well. This results in high blood sugar levels.

      People with T2D are at a higher risk of having a condition called chronic kidney disease
      (CKD). In people with CKD, the kidneys become damaged and do not work as they should. People
      with CKD can have trouble breathing and often have swelling in their arms and legs, and high
      blood pressure.

      People who have CKD and T2D are more likely to have other medical problems, such as heart
      disease.

      There are many treatments available to patients who have CKD and T2D. But, researchers need
      more information about how doctors in Canada are deciding which treatment to give these
      patients.

      In this study, the researchers will review health information from men and women with T2D who
      visited a doctor in 2019 and had check-ups for at least 6 months. The health information will
      be taken from a Canadian registry (or database) owned by LMC Diabetes & Endocrinology. The
      registry contains information from people that went to an LMC clinic. In this study, the
      researchers will learn how many of these people had T2D and CKD. They will learn the
      treatments these people received, and if they had other related medical problems. The
      researchers will also use surveys to ask the doctors about why they chose certain treatments.
observational model: Cohort
time perspective: Retrospective
measure: Proportion of patients with CKD in a large T2D population
time frame: Retrospectively analysis between January 1, 2019 and December 31, 2019
description: The data will be retrieved from the LMC Diabetes Registry, a Pan-Canadian registry of diabetes community-based specialist practices and used to develop a renal registry to investigate the primary objectives of the study
measure: Proportion of patients using the different therapies
time frame: Retrospectively analysis between January 1, 2019 and December 31, 2019
description: The therapies are: ACEi, ARBs, ACEi/ARBs, MRAs, GLP-1 RA and SGLT2i
measure: Proportion of patients with stage 1 CKD with moderate or greater albuminuria, stage 2 CKD with moderate or greater albuminuria, stage 3a CKD, stage 3b CKD, stage 4 CKD and stage 5 CKD in accordance with Canadian clinical practice guidelines
time frame: Retrospectively analysis between January 1, 2019 and December 31, 2019
description: Stage 1 CKD: eGFR (estimated glomerular filtration rate) ≥ 90 ml/min/1.73 m^2 Stage 2 CKD: eGFR between 60-89 ml/min/1.73 m^2 Stage 3a CKD: eGFR between 45-59 ml/min/1.73 m^2 Stage 3b CKD: eGFR between 30-44 ml/min/1.73 m^2 Stage 4 CKD: eGFR between 15-29 ml/min/1.73 m^2 Stage 5 CKD: eGFR <15 ml/min/1.73 m^2
measure: Proportion of patients with microalbuminuria and macroalbuminuria, in accordance with Canadian clinical practice guidelines
time frame: Retrospectively analysis between January 1, 2019 and December 31, 2019
description: Microalbuminuria: uACR (urine albumin-to-creatinine ratio) 2-20 mg/mmol Macroalbuminuria: uACR > 20 mg/mmol
measure: Proportion of patients within each albuminuria category (A1, A2 or A3), in accordance with KDIGO clinical practice guidelines
time frame: Retrospectively analysis between January 1, 2019 and December 31, 2019
description: KDIGO = Kidney Disease: Improving Global Outcomes
measure: Laboratory values for patients using either no therapy or using a therapy for ≥ 6 months
time frame: Retrospectively analysis between January 1, 2019 and December 31, 2019
description: Laboratory values including glucose, glycated hemoglobin (HbA1c), lipids, creatinine, electrolytes, eGFR, and uACR
measure: Proportion of patients with different comorbidities
time frame: Retrospectively analysis between January 1, 2019 and December 31, 2019
description: Comorbidities like hypertension, dyslipidemia, microvascular disease, macrovascular disease
measure: Proportion of healthcare provider prescriptions of RAS therapies (ACEi/ARB) used to treat hypertension, heart failure, coronary artery disease, CKD, or other condition
time frame: On the day of healthcare provider completes a questionnaire
description: RAS: renin angiotensin system ACEi: angiotensin converting enzyme inhibitors ARB: angiotensin receptor blocker
Healthcare providers will complete a questionnaire to determine their rationale for use of common therapies for CKD in T2D
measure: Proportion of healthcare provider prescriptions of GLP-1 RA used to treat glycemia management, hypertension, heart failure, coronary artery disease, CKD or other condition
time frame: On the day of healthcare provider completes a questionnaire
description: GLP-1 RA: glucagon-like peptide-1 receptor agonist
Healthcare providers will complete a questionnaire to determine their rationale for use of common therapies for CKD in T2D
measure: Proportion of healthcare provider prescriptions of MRAs used to treat hypertension, heart failure, coronary artery disease, CKD or other condition
time frame: On the day of healthcare provider completes a questionnaire
description: MRAs: mineralocorticoid receptor antagonists
Healthcare providers will complete a questionnaire to determine their rationale for use of common therapies for CKD in T2D
measure: Proportion of healthcare provider prescriptions of SGLT2i used to treat glycemia management, hypertension, heart failure, coronary artery disease, CKD or other condition
time frame: On the day of healthcare provider completes a questionnaire
description: SGLT2i: sodium-glucose co-transporter-2 inhibitors
Healthcare providers will complete a questionnaire to determine their rationale for use of common therapies for CKD in T2D
arm group label: Patients with T2D
description: Active patients (defined as patients seen by an LMC endocrinologist between January 1, 2019 and December 31, 2019) with T2D (Type 2 Diabetes). Among the patients with T2D, those identified with CKD will be included in the renal registry.
arm group label: Healthcare providers
description: Healthcare providers caring for patients with CKD and T2D.
intervention type: Drug
intervention name: The physician's prescription in routine clinical practice
description: This is an Observational study that will not involve prescription of the drugs.
arm group label: Patients with T2D
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: Canada
url: http://clinicaltrials.bayer.com/
description: Click here to find results for studies related to Bayer products
responsible party type: Sponsor
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
sharing ipd: No
ipd description: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.