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OpenTrials
Completed

NCT Number: NCT04417725

Burden of Chronic Kidney Disease (CKD), Type 2 Diabetes Mellitus (T2DM), and Comorbid T2DM/CKD in Alberta, Canada

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.

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Key information

Conditions

Chronic Kidney Diseases Chronic Disease Diabetes Mellitus Diabetes Mellitus, Type 2 Disease Attributes Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Type 2 Diabetes Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

Chronic kidney disease (CKD) has been ranked as the 10th leading cause of death in Canada as of 2013, while type 2 diabetes mellitus (T2DM) is one of the fastest growing diseases in Canada. There is a growing body of evidence that has examined these populations in real-world settings in Canada. The study described below will add to the growing body of literature that has examined CKD patients in Alberta and will contribute to an understanding of the epidemiology of CKD by stage, as well as healthcare resource utilization (HCRU) and costs. Furthermore, this study will contribute to a more nuanced understanding of the epidemiology, treatment patterns, HCRU and costs, and adverse events for T2DM patients with and without comorbid CKD in Alberta.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

(either of the following):

  • Chronic kidney disease identified using laboratory test and health administrative data
  • Type 2 diabetes mellitus identified using health administrative data

Exclusion criteria

  • Age < 18 years

Treatment and study plan

Not applicable - this is a non-interventional, observational study.

Other

Not applicable - this is a non-interventional, observational study.

Primary outcomes

  1. Incidence and prevalence

    Time frame: 2010 to 2018 fiscal years

    Incidence and prevalence of CKD (by stage), T2DM, and comorbid T2DM/CKD, including 1-, 4-, and 5-year period prevalence and incidence

Secondary outcomes

  1. Comorbidity and complication profiles and rates

    Time frame: 2010 to 2019 fiscal years

    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.

  2. Factors that influence the progression of CKD in patients

    Time frame: 2010 to 2019 fiscal years

    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.

  3. Healthcare resource use (HCRU) and associated costs for CKD patients

    Time frame: 2010 to 2019 fiscal years

    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.

  4. Stage-to-stage progression of CKD across the follow-up years in patients with CKD

    Time frame: 2010 to 2019 fiscal years

    This will be performed for all patients with CKD and stratified by T2DM status.

  5. Treatment patterns

    Time frame: 2010 to 2019 fiscal years

    • 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.

Sponsors and collaborators

Lead sponsor

Medlior Health Outcomes Research Ltd

Other

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2020
Study completion
2022
First posted
Jun 5, 2020
Registry last updated
Oct 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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