- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04417725
Burden of Chronic Kidney Disease (CKD), Type 2 Diabetes Mellitus (T2DM), and Comorbid T2DM/CKD in Alberta, Canada
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Patients with CKD will be defined using a published algorithm based on ICD-9-CM/ICD-10-CA diagnostic codes and eGFR/albuminuria laboratory test values.
Patients with T2DM will be defined using a published algorithm based on ICD-9-CM/ICD-10-CA diagnostic codes.
Patients with comorbid T2DM/CKD will be identified among patients identified with prevalent T2DM. CKD comorbidity will be defined as identified CKD within the two years prior or any time after the T2DM index date.
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Chronic kidney disease
Adult patients (≥18 years of age) with CKD were identified in Alberta during the case ascertainment period (April 1, 2010, to March 31, 2019), based on a validated algorithm incorporating ICD-9-CM/ICD-10-CA coding, estimated glomerular filtration rate, and albuminuria laboratory tests.
This is a non-interventional, observational study, and thus, no intervention was administered.
|
Not applicable - this is a non-interventional, observational study.
|
Type 2 diabetes mellitus
Adult patients with T2DM were identified in Alberta during the case ascertainment period (April 1, 2010 to March 31, 2018), based on a validated algorithm incorporating ICD-9-CM and ICD-10-CA codes.
This is a non-interventional, observational study, and thus, no intervention was administered.
|
Not applicable - this is a non-interventional, observational study.
|
Comorbid type 2 diabetes mellitus and chronic kidney disease
The derived T2DM cohort was used to identify patients with comorbid T2DM/CKD (stages 1-3) during the same case ascertainment period (April 1, 2010 to May 31, 2018).
The study cohort included T2DM patients with comorbid CKD (stages 1-3) identified in Alberta within the two years prior or after their T2DM index date, using the T2DM index date as the index date for this cohort.
This is a non-interventional, observational study, and thus, no intervention was administered.
|
Not applicable - this is a non-interventional, observational study.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
2010 to 2018 fiscal years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comorbidity and complication profiles and rates
Time Frame: 2010 to 2019 fiscal years
|
For all three cohorts, comorbidities and complications of interest include:
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. |
2010 to 2019 fiscal years
|
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.
|
2010 to 2019 fiscal years
|
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. |
2010 to 2019 fiscal years
|
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.
|
2010 to 2019 fiscal years
|
Treatment patterns
Time Frame: 2010 to 2019 fiscal years
|
|
2010 to 2019 fiscal years
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Glucose Metabolism Disorders
- Metabolic Diseases
- Urologic Diseases
- Endocrine System Diseases
- Disease Attributes
- Renal Insufficiency
- Chronic Disease
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Kidney Diseases
- Renal Insufficiency, Chronic
Other Study ID Numbers
- 1245.217
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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