check_circleStudy Completed

Chronic Kidney Disease in Type 2 Diabetes

Bayer Identifier:

21190

ClinicalTrials.gov Identifier:

NCT04445181

EudraCT Number:

Not Available

EU CT Number:

Not Available
A study using the LMC Diabetes Registry to learn more about chronic kidney disease (CKD) in Canadian patients with type 2 diabetes (T2D)

Trial purpose

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.

Key Participants Requirements

Sex

All

Age

NaN - N/A
  • - Clinical diagnosis of T2D as captured in the LMC EMR system
    - Assessed by an LMC endocrinologist between January 1, 2019 and December 31, 2019
    - Followed by an LMC endocrinologist for ≥ 6 months prior to inclusion in the cohort
    - Informed consent to use patient medical record data for research purposes was provided

    Among patients who meet the inclusion criteria, estimated glomerular filtration rate (eGFR) ≤ 60 ml/min/1.73 m^2 and/or urine albumin-to-creatinine ratio (uACR) ≥ 2 mg/mmol will be used to identify the cohort of patients with T2D and CKD
  • - Any patients with documented non-diabetic etiology for renal disease will be excluded from the numerator (number of patients with CKD and T2D) when determining the primary endpoint

Trial summary

Enrollment Goal
14873
Trial Dates
July 2020 - November 2020
Phase
N/A
Could I Receive a placebo
No
Products
Unspecified
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
a databasea database, Canada

Primary Outcome

  • Proportion of patients with CKD in a large T2D population
    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
    date_rangeTime Frame:
    Retrospectively analysis between January 1, 2019 and December 31, 2019

Secondary Outcome

  • Proportion of patients using the different therapies
    The therapies are: ACEi, ARBs, ACEi/ARBs, MRAs, GLP-1 RA and SGLT2i
    date_rangeTime Frame:
    Retrospectively analysis between January 1, 2019 and December 31, 2019
  • 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
    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
    date_rangeTime Frame:
    Retrospectively analysis between January 1, 2019 and December 31, 2019
  • Proportion of patients with microalbuminuria and macroalbuminuria, in accordance with Canadian clinical practice guidelines
    Microalbuminuria: uACR (urine albumin-to-creatinine ratio) 2-20 mg/mmol Macroalbuminuria: uACR > 20 mg/mmol
    date_rangeTime Frame:
    Retrospectively analysis between January 1, 2019 and December 31, 2019
  • Proportion of patients within each albuminuria category (A1, A2 or A3), in accordance with KDIGO clinical practice guidelines
    KDIGO = Kidney Disease: Improving Global Outcomes
    date_rangeTime Frame:
    Retrospectively analysis between January 1, 2019 and December 31, 2019
  • Laboratory values for patients using either no therapy or using a therapy for ≥ 6 months
    Laboratory values including glucose, glycated hemoglobin (HbA1c), lipids, creatinine, electrolytes, eGFR, and uACR
    date_rangeTime Frame:
    Retrospectively analysis between January 1, 2019 and December 31, 2019
  • Proportion of patients with different comorbidities
    Comorbidities like hypertension, dyslipidemia, microvascular disease, macrovascular disease
    date_rangeTime Frame:
    Retrospectively analysis between January 1, 2019 and December 31, 2019
  • Proportion of healthcare provider prescriptions of RAS therapies (ACEi/ARB) used to treat hypertension, heart failure, coronary artery disease, CKD, or other condition
    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
    date_rangeTime Frame:
    On the day of healthcare provider completes a questionnaire
  • Proportion of healthcare provider prescriptions of GLP-1 RA used to treat glycemia management, hypertension, heart failure, coronary artery disease, CKD or other condition
    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
    date_rangeTime Frame:
    On the day of healthcare provider completes a questionnaire
  • Proportion of healthcare provider prescriptions of MRAs used to treat hypertension, heart failure, coronary artery disease, CKD or other condition
    MRAs: mineralocorticoid receptor antagonists Healthcare providers will complete a questionnaire to determine their rationale for use of common therapies for CKD in T2D
    date_rangeTime Frame:
    On the day of healthcare provider completes a questionnaire
  • Proportion of healthcare provider prescriptions of SGLT2i used to treat glycemia management, hypertension, heart failure, coronary artery disease, CKD or other condition
    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
    date_rangeTime Frame:
    On the day of healthcare provider completes a questionnaire

Trial design

Canadian REgistry of Chronic Kidney Disease in Diabetes Outcomes (CREDO) Study
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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