NCT04417725

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
588,170

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2008

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
12 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 2, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 5, 2020

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2022

Completed
Last Updated

October 31, 2023

Status Verified

October 1, 2023

Enrollment Period

12 years

First QC Date

June 2, 2020

Last Update Submit

October 29, 2023

Conditions

Chronic Kidney DiseasesType 2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • 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

    2010 to 2018 fiscal years

Secondary Outcomes (5)

  • Comorbidity and complication profiles and rates

    2010 to 2019 fiscal years

  • Factors that influence the progression of CKD in patients

    2010 to 2019 fiscal years

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

    2010 to 2019 fiscal years

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

    2010 to 2019 fiscal years

  • Treatment patterns

    2010 to 2019 fiscal years

Study Arms (3)

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.

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.

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.

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

Interventions

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

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

Chronic kidney diseaseComorbid type 2 diabetes mellitus and chronic kidney diseaseType 2 diabetes mellitus

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

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

You may not qualify if:

  • Age \< 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Renal Insufficiency, ChronicDiabetes Mellitus, Type 2

Interventions

Observation

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director and Managing Principal

Study Record Dates

First Submitted

June 2, 2020

First Posted

June 5, 2020

Study Start

April 1, 2008

Primary Completion

March 31, 2020

Study Completion

August 31, 2022

Last Updated

October 31, 2023

Record last verified: 2023-10