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Clinical Trial Details

Trial ID: L1133
Source ID: NCT04445181
Associated Drug: The Physician's Prescription In Routine Clinical Practice
Title: A Study Using the LMC Diabetes Registry to Learn More About Chronic Kidney Disease (CKD) in Canadian Patients With Type 2 Diabetes (T2D)
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Chronic Kidney Disease in Type 2 Diabetes
Interventions: DRUG: The physician's prescription in routine clinical practice
Outcome Measures: 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|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|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|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|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|Proportion of patients with different comorbidities, Comorbidities like hypertension, dyslipidemia, microvascular disease, macrovascular disease, Retrospectively analysis between January 1, 2019 and December 31, 2019|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|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|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|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
Sponsor/Collaborators: Sponsor: Bayer
Gender: ALL
Age: CHILD, ADULT, OLDER_ADULT
Phases:
Enrollment: 14873
Study Type: OBSERVATIONAL
Study Designs: Observational Model: |Time Perspective: p
Start Date: 2020-07-01
Completion Date: 2020-11-23
Results First Posted:
Last Update Posted: 2021-10-05
Locations: A Database, A Database, Canada
URL: https://clinicaltrials.gov/show/NCT04445181