A Study Using the LMC Diabetes Registry to Learn More About Chronic Kidney Disease (CKD) in Canadian Patients With Type 2 Diabetes (T2D)
Canadian REgistry of Chronic Kidney Disease in Diabetes Outcomes (CREDO) Study
1 other identifier
observational
14,873
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 21, 2020
CompletedFirst Posted
Study publicly available on registry
June 24, 2020
CompletedStudy Start
First participant enrolled
July 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 23, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 23, 2020
CompletedOctober 5, 2021
September 1, 2021
5 months
June 21, 2020
September 28, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of patients with CKD in a large T2D population
The data will be retrieved from the LMC Diabetes Registry, a Pan-Canadian registry of diabetes community-based specialist practices and used to develop a renal registry to investigate the primary objectives of the study
Retrospectively analysis between January 1, 2019 and December 31, 2019
Secondary Outcomes (10)
Proportion of patients using the different therapies
Retrospectively analysis between January 1, 2019 and December 31, 2019
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
Retrospectively analysis between January 1, 2019 and December 31, 2019
Proportion of patients with microalbuminuria and macroalbuminuria, in accordance with Canadian clinical practice guidelines
Retrospectively analysis between January 1, 2019 and December 31, 2019
Proportion of patients within each albuminuria category (A1, A2 or A3), in accordance with KDIGO clinical practice guidelines
Retrospectively analysis between January 1, 2019 and December 31, 2019
Laboratory values for patients using either no therapy or using a therapy for ≥ 6 months
Retrospectively analysis between January 1, 2019 and December 31, 2019
- +5 more secondary outcomes
Study Arms (2)
Patients with T2D
Active patients (defined as patients seen by an LMC endocrinologist between January 1, 2019 and December 31, 2019) with T2D (Type 2 Diabetes). Among the patients with T2D, those identified with CKD will be included in the renal registry.
Healthcare providers
Healthcare providers caring for patients with CKD and T2D.
Interventions
This is an Observational study that will not involve prescription of the drugs.
Eligibility Criteria
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.
You may qualify if:
- Clinical diagnosis of T2D as captured in the LMC EMR system
- Assessed by an LMC endocrinologist between January 1, 2019 and December 31, 2019
- Informed consent to use patient medical record data for research purposes was provided
You may not qualify if:
- \- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (1)
A Database
A Database, Canada
Related Publications (1)
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.
PMID: 34426012DERIVED
Related Links
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 21, 2020
First Posted
June 24, 2020
Study Start
July 1, 2020
Primary Completion
November 23, 2020
Study Completion
November 23, 2020
Last Updated
October 5, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.