Clinical trial NCT04445181: A Study Using the LMC Diabetes Registry to Learn More About Chronic Kidney Disease (CKD) in Canadian Patients With Type 2 Diabetes (T2D)
Official title: Canadian REgistry of Chronic Kidney Disease in Diabetes Outcomes (CREDO) Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Disease in Type 2 Diabetes
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2020-06-24
Enrollment: 14873
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include active LMC patients with T2D. This population will be used to determine the prevalence of CKD in patients with T2D. Patients identified with T2D and CKD will form the cohort for all subsequent analysis.

Brief summary: In people with type 2 diabetes (T2D), the body does not make enough of a hormone called insulin or does not use insulin well. This results in high blood sugar levels.

People with T2D are at a higher risk of having a condition called chronic kidney disease (CKD). In people with CKD, the kidneys become damaged and do not work as they should. People with CKD can have trouble breathing and often have swelling in their arms and legs, and high blood pressure.

People who have CKD and T2D are more likely to have other medical problems, such as heart disease.

There are many treatments available to patients who have CKD and T2D. But, researchers need more information about how doctors in Canada are deciding which treatment to give these patients.

In this study, the researchers will review health information from men and women with T2D who visited a doctor in 2019 and had check-ups for at least 6 months. The health information will be taken from a Canadian registry (or database) owned by LMC Diabetes \& Endocrinology. The registry contains information from people that went to an LMC clinic. In this study, the researchers will learn how many of these people had T2D and CKD. They will learn the treatments these people received, and if they had other related medical problems. The researchers will also use surveys to ask the doctors about why they chose certain treatments.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of T2D as captured in the LMC EMR system
* Assessed by an LMC endocrinologist between January 1, 2019 and December 31, 2019
* Followed by an LMC endocrinologist for ≥ 6 months prior to inclusion in the cohort
* Informed consent to use patient medical record data for research purposes was provided

Among patients who meet the inclusion criteria, estimated glomerular filtration rate (eGFR) ≤ 60 ml/min/1.73 m\^2 and/or urine albumin-to-creatinine ratio (uACR) ≥ 2 mg/mmol will be used to identify the cohort of patients with T2D and CKD

Exclusion Criteria:

- Any patients with documented non-diabetic etiology for renal disease will be excluded from the numerator (number of patients with CKD and T2D) when determining the primary endpoint

Primary outcomes:
measure: Proportion of patients with CKD in a large T2D population
timeFrame: Retrospectively analysis between January 1, 2019 and December 31, 2019
Secondary outcomes:
measure: Proportion of patients using the different therapies
timeFrame: Retrospectively analysis between January 1, 2019 and December 31, 2019
measure: Proportion of patients with stage 1 CKD with moderate or greater albuminuria, stage 2 CKD with moderate or greater albuminuria, stage 3a CKD, stage 3b CKD, stage 4 CKD and stage 5 CKD in accordance with Canadian clinical practice guidelines
timeFrame: Retrospectively analysis between January 1, 2019 and December 31, 2019
measure: Proportion of patients with microalbuminuria and macroalbuminuria, in accordance with Canadian clinical practice guidelines
timeFrame: Retrospectively analysis between January 1, 2019 and December 31, 2019
measure: Proportion of patients within each albuminuria category (A1, A2 or A3), in accordance with KDIGO clinical practice guidelines
timeFrame: Retrospectively analysis between January 1, 2019 and December 31, 2019
measure: Laboratory values for patients using either no therapy or using a therapy for ≥ 6 months
timeFrame: Retrospectively analysis between January 1, 2019 and December 31, 2019
measure: Proportion of patients with different comorbidities
timeFrame: Retrospectively analysis between January 1, 2019 and December 31, 2019
measure: Proportion of healthcare provider prescriptions of RAS therapies (ACEi/ARB) used to treat hypertension, heart failure, coronary artery disease, CKD, or other condition
timeFrame: On the day of healthcare provider completes a questionnaire
measure: Proportion of healthcare provider prescriptions of GLP-1 RA used to treat glycemia management, hypertension, heart failure, coronary artery disease, CKD or other condition
timeFrame: On the day of healthcare provider completes a questionnaire
measure: Proportion of healthcare provider prescriptions of MRAs used to treat hypertension, heart failure, coronary artery disease, CKD or other condition
timeFrame: On the day of healthcare provider completes a questionnaire
measure: Proportion of healthcare provider prescriptions of SGLT2i used to treat glycemia management, hypertension, heart failure, coronary artery disease, CKD or other condition
timeFrame: On the day of healthcare provider completes a questionnaire
Other outcomes:
Locations:
city: A Database
country: Canada
facility: A Database
Study officials:
References:
citation: Chu L, Fuller M, Jervis K, Ciaccia A, Abitbol A. Prevalence of Chronic Kidney Disease in Type 2 Diabetes: The Canadian REgistry of Chronic Kidney Disease in Diabetes Outcomes (CREDO) Study. Clin Ther. 2021 Sep;43(9):1558-1573. doi: 10.1016/j.clinthera.2021.07.015. Epub 2021 Aug 21.