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NCT Number: NCT05004428

A Study to Learn More About Chronic Kidney Disease (CKD) in Patients With Type 2 Diabetes Mellitus (T2DM)

In this observational study, data from the recent past of patients with type 2 diabetes mellitus and chronic kidney disease will be studied.

Type 2 diabetes mellitus (T2DM) is a condition in which the body does not make enough of a hormone called insulin or does not use insulin well. This results in high blood sugar levels. About half of people with T2DM also have a condition called chronic kidney disease (CKD). In people with CKD, the kidneys' ability to work as how it should decreases over time.

In this study, researchers want to learn more about the CKD in T2DM patients in Alberta, Canada. This will help them to know the chances to improve the care of these patients.

The researchers will look at the health information from adult men and women in Alberta who were diagnosed with T2DM before 2018 and visited a doctor to have check-ups in 2018. They will find out about how many of these people had CKD and how severe their CKD was. The researchers will collect data about the age and gender of these patients, how long they had T2DM and if they had other related medical problems. The researchers will also learn how these patients were treated based on their kidney condition and how much money was spent on these treatments.

This study will collect information from the health records of about 270,000 patients with T2DM who were living in Alberta, Canada. This information will come from the Alberta Kidney Disease Network (AKDN) database. Besides this data collection, no further tests or examinations are planned in this study.

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Key information

Conditions

Type 2 Diabetes Mellitus Autoimmune Diseases Cardiovascular Diseases Chronic Disease Chronic Kidney Disease Diabetes Mellitus Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Disease Attributes Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Immune System Diseases Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations

Multiple Locations, Canada

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • A cohort of adults (18 years and older) with Type 2 Diabetes Mellitus (T2DM) who resided in Alberta on the index date (December 31, 2018) and were registered with Alberta Health will be included. All Alberta residents are eligible for Alberta Health Insurance Plan coverage and over 99% participate.

Exclusion criteria

  • Patients with type 1 DM (T1DM) (International Classification of Diseases, Ninth Revision [ICD-9] code: 250.x1 and 250.x3) in any of their previous records.

Treatment and study plan

No intervention

Other

Retrospective population-based study utilizing administrative data without any intervention.

Primary outcomes

  1. Percentage of Type 2 Diabetes Mellitus (T2DM) patients with Chronic Kidney Disease (CKD) in database.

    Time frame: Baseline

    Percentage of T2DM patients with CKD as per hemoglobin A1C, and stage of CKD as defined by a) baseline Kidney Disease: Improving Global Outcomes (KDIGO) guidelines CKD category, and b) eGFR ≥25 to <75 mL/min/1.73 m2 and ACR ≥30 to ≤5,000 mg/g.

Secondary outcomes

  1. Descriptive analyses of clinical characteristics of patients in database.

    Time frame: Baseline

    Duration of diabetes, comorbities and slope of eGFR

  2. Descriptive analyses of demographic data.

    Time frame: Baseline

    Age, sex, urban or rural residence.

  3. Rate of decline in estimated glomerular filtration rate (eGFR)

    Time frame: Retrospectively 3 years

  4. Number of patients with CKD dispensed the medication or therapeutic class over a 1-year time period

    Time frame: from January 1, 2018 to December 31, 2018

  5. The proportion of patients with CKD that experience a health outcome of interest over a 1-year time period

    Time frame: from January 1, 2018 to December 31, 2018

  6. Health care resource utilization among patients

    Time frame: from January 1, 2018 to December 31, 2018

  7. Annual average costs among patients

    Time frame: from January 1, 2018 to December 31, 2018

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Chronic Kidney Disease in Type 2 Diabetes Mellitus

Acronym: CKD-T2DM

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 13, 2021
Registry last updated
Feb 14, 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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