Chronic Kidney DiseasesNCT04417725
Burden of Chronic Kidney Disease (CKD), Type 2 Diabetes Mellitus (T2DM), and Comorbid T2DM/CKD in Alberta, Canada
An observational study of Chronic Kidney Diseases and Type 2 Diabetes, run by Medlior Health Outcomes Research Ltd.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Diseases, Type 2 Diabetes
- What is being tested?
- Not applicable - this is a non-interventional, observational study.
- How many people
- 588,170 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2008to 31 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Chronic kidney disease identified using laboratory test and health administrative data
- Type 2 diabetes mellitus identified using health administrative data
Who cannot join
- Age < 18 years
About this study
Official 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
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.
Read the detailed description
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.
- Conditions
- Chronic Kidney Diseases, Type 2 Diabetes
- Being tested
- Not applicable - this is a non-interventional, observational study.
- Medical subject headings
- Renal Insufficiency, Chronic, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not applicable - this is a non-interventional, observational study.Other
Not applicable - this is a non-interventional, observational study.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: 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. Receives: Other: 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. Receives: Other: Not applicable - this is a non-interventional, observational study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and prevalence
Incidence and prevalence of CKD (by stage), T2DM, and comorbid T2DM/CKD, including 1-, 4-, and 5-year period prevalence and incidence
Measured: 2010 to 2018 fiscal years
Secondary outcomes (5)
Comorbidity and complication profiles and rates
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.
Measured: 2010 to 2019 fiscal years
Factors that influence the progression of CKD in patients
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.
Measured: 2010 to 2019 fiscal years
Healthcare resource use (HCRU) and associated costs for CKD patients
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.
Measured: 2010 to 2019 fiscal years
Stage-to-stage progression of CKD across the follow-up years in patients with CKD
This will be performed for all patients with CKD and stratified by T2DM status.
Measured: 2010 to 2019 fiscal years
Treatment patterns
- 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.
Measured: 2010 to 2019 fiscal years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2020
- Study start1 Apr 2008
- Primary completion31 Mar 2020
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 588,170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medlior Health Outcomes Research Ltd
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tara Cowling, Medlior Health Outcomes Research Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04417725
- Sponsor's protocol ID
- 1245.217
- Status last verified
- Oct 2023
- First submitted
- 2 Jun 2020
- Last updated
- 31 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04417725
- Acronym / sponsor ID
- 1245.217
- Conditions
- Chronic Kidney Diseases, Type 2 Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 588,170 participants (actual)
- Lead sponsor
- Medlior Health Outcomes Research LtdUniversity, hospital or other
- Study start
- 1 Apr 2008 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 5 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Chronic kidney disease | – | Other: Not applicable - this is a non-interventional, observational study.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. |
| Type 2 diabetes mellitus | – | Other: Not applicable - this is a non-interventional, observational study.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. |
| Comorbid type 2 diabetes mellitus and chronic kidney disease | – | Other: Not applicable - this is a non-interventional, observational study.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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Chronic kidney disease identified using laboratory test and health administrative data
- Type 2 diabetes mellitus identified using health administrative data
Key exclusion criteria (1 listed)
- Age < 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Not applicable - this is a non-interventional, observational study.Not applicable - this is a non-interventional, observational study. | Other | Chronic kidney disease, Comorbid type 2 diabetes mellitus and chronic kidney disease, Type 2 diabetes mellitus |
Primary outcome
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
5 secondary outcomes
Comorbidity and complication profiles and rates
Time frame: 2010 to 2019 fiscal years
Factors that influence the progression of CKD in patients
Time frame: 2010 to 2019 fiscal years
Healthcare resource use (HCRU) and associated costs for CKD patients
Time frame: 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
Treatment patterns
Time frame: 2010 to 2019 fiscal years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Diseases and Type 2 Diabetes, run by Medlior Health Outcomes Research Ltd.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and prevalence (time frame: 2010 to 2018 fiscal years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2023.