Virtual Kidney Check and Follow-up

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Kidney Disease, Chronic
• Intervention / Treatment: Other: population-based screening for chronic kidney disease

• Study Type: Interventional
• Enrollment (Estimated): 3356
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Winnipeg, Canada
    • Chronic Disease Innovation Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Patient contact via mail with a letter and laboratory requisition; Patient contact via mail with a letter and laboratory requisition for serum creatinine and urine albumin to creatinine ratio	Other: population-based screening for chronic kidney disease; Randomized controlled trial that uses an integrated health platform for eligibility and outcome assessments
Other: Patient and primary care network contact via mail with a letter but no laboratory requisition	Other: population-based screening for chronic kidney disease; Randomized controlled trial that uses an integrated health platform for eligibility and outcome assessments

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of individuals who undergo screening for Chronic Kidney Disease (CKD)	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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
New diagnosis of CKD (Chronic Kidney Disease)	The proportion of individuals with a new diagnosis of CKD by estimated glomerular filtration rate (eGFR) or albuminuria for each screening strategy	5 years
Anti-hyperintensive therapy	The proportion of individuals treated with anti-hyperintensive therapy for each screening strategy	5 years
Renin angiotensin aldosterone inhibitor blockade treatment	The proportion of individuals treated with renin angiotensin aldosterone inhibitor blockade for each screening strategy	5 years
Sodium Glucose Cotransporter 2 (SGLT2) inhibition treatment	The proportion of individuals treated with Sodium Glucose Cotransporter 2 (SGLT2) inhibition for each screening strategy	5 years
Mineral corticoid receptor antagonist treatment	The proportion of individuals treated with a mineral corticoid receptor antagonist for each screening strategy	5 years
Statins treatment	The proportion of individuals treated with statins for each screening strategy	5 years
Anti-platelet agents treatment	The proportion of individuals treated with anti-platelet agents for each screening strategy	5 years
Hospitalizations for diseases	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	5 years
The number of antihypertensive medications	The number of antihypertensive medications per individual for each screening strategy	5 years
Change in estimated Glomerular Filtration Rate, urine albumin to creatinine ratio, kidney failure risk equation measurements	Change in estimated Glomerular Filtration Rate, urine albumin to creatinine ratio, kidney failure risk equation measurements for each individual	5 years
estimated Glomerular Filtration Rate slope	Tracking changes in estimated Glomerular Filtration Rate over time indicates progression of chronic kidney disease for each individual	5 years
Number of individuals with 40 % decline in estimated Glomerular Filtration Rate	Number of individuals with 40 % decline in estimated Glomerular Filtration Rate	5 years
Number of individuals with kidney failure	Number of individuals with kidney failure	5 years
Number of individuals on dialysis	Number of individuals on dialysis	5 years
Number of individuals to receive kidney transplant	Number of individuals to receive kidney transplant	5 years
Number of individuals who have died	Number of individuals who have died	5 years

Collaborators and Investigators

• Sponsor: University of Manitoba
• Collaborators: Boehringer Ingelheim; Research Manitoba; First Nations Health and Social Secretariat of Manitoba; Seven Oaks General Hospital; Manitoba Health, Seniors and Long-Term Care, Province of Manitoba; Shared Health Manitoba
• Investigators: Principal Investigator: David Collister, MD, PhD, FRCPC, University of Manitoba

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2024
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): April 1, 2029

Study Registration Dates

• First Submitted: December 19, 2023
• First Submitted That Met QC Criteria: January 15, 2024
• First Posted (Actual): January 25, 2024

Study Record Updates

• Last Update Posted (Estimated): September 2, 2025
• Last Update Submitted That Met QC Criteria: August 25, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Renal Insufficiency, Chronic
• Other Study ID Numbers: HS24845 (H2021:170)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No