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

02/06/2020
02/08/2021
EU PAS number:
EUPAS35286
Study
Ongoing
Study identification

EU PAS number

EUPAS35286

Study ID

42345

Official title and acronym

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

DARWIN EU® study

No

Study countries

Canada

Study description

The purpose of this study is to describe the incidence, prevalence, comorbidities and complication rates, treatment patterns and progression among patients identified with CKD, T2DM and comorbid T2DM/CKD. Further healthcare resource utilization and associated costs will be examined for patients with CKD. The study population represents three cohorts of adults in Alberta, Canada with: 1) CKD, 2) T2DM, and 3) T2DM/CKD. These cohorts will be defined using published definitions of diagnosis codes from the International Classification of Diseases, Ninth Revision, Clinical Modification/International Statistical Classification of Diseases and Related Health Problems, 10th Revision, Canada. The diagnosis codes for these conditions can be in any position in the Discharge Abstract Database (DAD), National Ambulatory Care Reporting System (NACRS), or Practitioner Claims datasets between April 1, 2010 and March 31, 2019. Patients with CKD will also be identified utilizing laboratory tests of estimated glomerular filtration rate and albuminuria stage (based on albumin:creatinine ratio, protein:creatinine ratio and the dipstick test). Further inclusion criteria and published/validated algorithms were applied to define the three study cohorts of interest. A data request will be placed with Alberta Health to provide data for patients meeting the study inclusion criteria. Datasets of interest include the DAD, NACRS, Population Registry, Practitioner Claims, Pharmaceutical Information Network, Alberta Blue Cross as well as the Laboratory Services dataset from Alberta Health Services. The index date will be the first diagnostic code date (or laboratory test date for patients with CKD) within the case ascertainment period. Two years of retrospective data (from April 1, 2008) will be requested such that incident cases can be be identified. The study will provide evidence for the burden of disease and inform patient management for CKD, T2DM and T2DM/CKD in Alberta.

Study status

Ongoing
Research institutions and networks

Institutions

Contact details

Tara Cowling

Primary lead investigator

Study timelines

Date when funding contract was signed

Actual:

Study start date

Planned:
Actual:

Data analysis start date

Actual:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Boehringer Ingelheim
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable