Virtual Kidney Check and Follow-up

Not Applicable

• Conditions: Kidney Disease, Chronic
• Interventions: Other: population-based screening for chronic kidney disease

• Registration Number: NCT06223750
• Lead Sponsor: University of Manitoba

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-12-19
• Study First Submitted QC: 2024-01-15
• Study First Posted: 2024-01-25
• Status Verified: 2024-06
• Last Update Submitted: 2024-10-29
• Last Update Posted: 2024-10-31
• Study Start: 2024-11
• Primary Completion: 2029-04
• Study Completion: 2029-04

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 3356

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patient contact via mail with a letter and laboratory requisition	population-based screening for chronic kidney disease	Patient contact via mail with a letter and laboratory requisition for serum creatinine and urine albumin to creatinine ratio
Patient and primary care network contact via mail with a letter but no laboratory requisition	population-based screening for chronic kidney disease	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
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
The number of antihypertensive medications	5 years	The number of antihypertensive medications per individual 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
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
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 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

Trial Locations

Locations (1)

Chronic Disease Innovation Centre; 🇨🇦 Winnipeg, Canada