Chronic Kidney Disease in Type 2 Diabetes Clinical Trial
Official title:
Canadian REgistry of Chronic Kidney Disease in Diabetes Outcomes (CREDO) Study
| NCT number | NCT04445181 |
| Other study ID # | 21190 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | July 1, 2020 |
| Est. completion date | November 23, 2020 |
| Verified date | September 2021 |
| Source | Bayer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 14873 |
| Est. completion date | November 23, 2020 |
| Est. primary completion date | November 23, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Canada | A Database | A Database |
| Lead Sponsor | Collaborator |
|---|---|
| Bayer |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Proportion of patients using the different therapies | The therapies are: ACEi, ARBs, ACEi/ARBs, MRAs, GLP-1 RA and SGLT2i | Retrospectively analysis between January 1, 2019 and December 31, 2019 | |
| Secondary | 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 | Stage 1 CKD: eGFR (estimated glomerular filtration rate) = 90 ml/min/1.73 m^2 Stage 2 CKD: eGFR between 60-89 ml/min/1.73 m^2 Stage 3a CKD: eGFR between 45-59 ml/min/1.73 m^2 Stage 3b CKD: eGFR between 30-44 ml/min/1.73 m^2 Stage 4 CKD: eGFR between 15-29 ml/min/1.73 m^2 Stage 5 CKD: eGFR <15 ml/min/1.73 m^2 | Retrospectively analysis between January 1, 2019 and December 31, 2019 | |
| Secondary | Proportion of patients with microalbuminuria and macroalbuminuria, in accordance with Canadian clinical practice guidelines | Microalbuminuria: uACR (urine albumin-to-creatinine ratio) 2-20 mg/mmol Macroalbuminuria: uACR > 20 mg/mmol | Retrospectively analysis between January 1, 2019 and December 31, 2019 | |
| Secondary | Proportion of patients within each albuminuria category (A1, A2 or A3), in accordance with KDIGO clinical practice guidelines | KDIGO = Kidney Disease: Improving Global Outcomes | Retrospectively analysis between January 1, 2019 and December 31, 2019 | |
| Secondary | Laboratory values for patients using either no therapy or using a therapy for = 6 months | Laboratory values including glucose, glycated hemoglobin (HbA1c), lipids, creatinine, electrolytes, eGFR, and uACR | Retrospectively analysis between January 1, 2019 and December 31, 2019 | |
| Secondary | Proportion of patients with different comorbidities | Comorbidities like hypertension, dyslipidemia, microvascular disease, macrovascular disease | Retrospectively analysis between January 1, 2019 and December 31, 2019 | |
| Secondary | Proportion of healthcare provider prescriptions of RAS therapies (ACEi/ARB) used to treat hypertension, heart failure, coronary artery disease, CKD, or other condition | RAS: renin angiotensin system ACEi: angiotensin converting enzyme inhibitors ARB: angiotensin receptor blocker
Healthcare providers will complete a questionnaire to determine their rationale for use of common therapies for CKD in T2D |
On the day of healthcare provider completes a questionnaire | |
| Secondary | Proportion of healthcare provider prescriptions of GLP-1 RA used to treat glycemia management, hypertension, heart failure, coronary artery disease, CKD or other condition | GLP-1 RA: glucagon-like peptide-1 receptor agonist
Healthcare providers will complete a questionnaire to determine their rationale for use of common therapies for CKD in T2D |
On the day of healthcare provider completes a questionnaire | |
| Secondary | Proportion of healthcare provider prescriptions of MRAs used to treat hypertension, heart failure, coronary artery disease, CKD or other condition | MRAs: mineralocorticoid receptor antagonists
Healthcare providers will complete a questionnaire to determine their rationale for use of common therapies for CKD in T2D |
On the day of healthcare provider completes a questionnaire | |
| Secondary | Proportion of healthcare provider prescriptions of SGLT2i used to treat glycemia management, hypertension, heart failure, coronary artery disease, CKD or other condition | SGLT2i: sodium-glucose co-transporter-2 inhibitors
Healthcare providers will complete a questionnaire to determine their rationale for use of common therapies for CKD in T2D |
On the day of healthcare provider completes a questionnaire |