Kidney Disease, Chronic
Conditions
Brief summary
The goal of this clinical trial is to determine the most effective way to complete population-based screening for chronic kidney disease (CKD) in First Nations adults in Manitoba. The main questions it aims to answer are: * To identify chronic kidney disease in First Nations adults in Manitoba * To risk stratify patients as low, moderate and high risk of kidney failure and organize active surveillance by risk category * To initiate treatments to prevent to progression of chronic kidney disease in individuals at risk of kidney failure Participants will be randomized to: 1. Patient contact via mail with a letter and laboratory requisition for serum creatinine and urine Albumin Creatinine Ratio 2. Patient and primary care network contact via mail with a letter but no laboratory requisition The primary outcome is the difference between groups in the proportion of individuals who undergo screening for chronic kidney disease within 6 months.
Interventions
OTHERpopulation-based screening for chronic kidney disease
Randomized controlled trial that uses an integrated health platform for eligibility and outcome assessments
Sponsors
Boehringer Ingelheim
Research Manitoba
Manitoba Health, Seniors and Long-Term Care, Province of Manitoba
First Nations Health and Social Secretariat of Manitoba
Shared Health Manitoba
Seven Oaks General Hospital
University of Manitoba
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age\>= 18 years * Resident of Manitoba * First Nations * Urban, rural or remote location
Exclusion criteria
* Kidney failure (dialysis or transplant) * chronic kidney disease (estimated Glomerular Filtration Rate \<60 milliliter/1.73square meter for 3 months) * Screening for chronic kidney disease with estimated Glomerular Filtration Rate or Albumin to Creatinine ratio in the last 2 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of individuals who undergo screening for Chronic Kidney Disease (CKD) | 6 months | The proportion of individuals screened for Chronic Kidney Disease using one screening strategy is compared to the proportion of individuals screened using the other screening strategy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anti-hyperintensive therapy | 5 years | The proportion of individuals treated with anti-hyperintensive therapy for each screening strategy |
| Renin angiotensin aldosterone inhibitor blockade treatment | 5 years | The proportion of individuals treated with renin angiotensin aldosterone inhibitor blockade for each screening strategy |
| Sodium Glucose Cotransporter 2 (SGLT2) inhibition treatment | 5 years | The proportion of individuals treated with Sodium Glucose Cotransporter 2 (SGLT2) inhibition for each screening strategy |
| Mineral corticoid receptor antagonist treatment | 5 years | The proportion of individuals treated with a mineral corticoid receptor antagonist for each screening strategy |
| Statins treatment | 5 years | The proportion of individuals treated with statins for each screening strategy |
| Anti-platelet agents treatment | 5 years | The proportion of individuals treated with anti-platelet agents for each screening strategy |
| Hospitalizations for diseases | 5 years | The proportion of individuals treated with hospitalizations for acute coronary syndrome, peripheral vascular disease, cerebrovascular disease or heart failure rate. Urine albumin to creatinine ratio, kidney failure risk equation (KFRE) measurements are also calculated for each screening strategy |
| New diagnosis of CKD (Chronic Kidney Disease) | 5 years | The proportion of individuals with a new diagnosis of CKD by estimated glomerular filtration rate (eGFR) or albuminuria for each screening strategy |
| Change in estimated Glomerular Filtration Rate, urine albumin to creatinine ratio, kidney failure risk equation measurements | 5 years | Change in estimated Glomerular Filtration Rate, urine albumin to creatinine ratio, kidney failure risk equation measurements for each individual |
| estimated Glomerular Filtration Rate slope | 5 years | Tracking changes in estimated Glomerular Filtration Rate over time indicates progression of chronic kidney disease for each individual |
| Number of individuals with 40 % decline in estimated Glomerular Filtration Rate | 5 years | Number of individuals with 40 % decline in estimated Glomerular Filtration Rate |
| Number of individuals with kidney failure | 5 years | Number of individuals with kidney failure |
| Number of individuals on dialysis | 5 years | Number of individuals on dialysis |
| Number of individuals to receive kidney transplant | 5 years | Number of individuals to receive kidney transplant |
| Number of individuals who have died | 5 years | Number of individuals who have died |
| The number of antihypertensive medications | 5 years | The number of antihypertensive medications per individual for each screening strategy |
Countries
Canada
Outcome results
None listed