Clinical trial NCT06223750: Virtual Kidney Check and Follow-up
Official title: Virtual Kidney Check and Follow-up
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Kidney Disease, Chronic
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: Boehringer Ingelheim
name: Research Manitoba
name: Manitoba Health, Seniors and Long-Term Care, Province of Manitoba
name: First Nations Health and Social Secretariat of Manitoba
name: Shared Health Manitoba
name: Seven Oaks General Hospital
First posted: 2024-01-25
Enrollment: 3356
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.


Eligibility criteria: 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

Primary outcomes:
measure: The proportion of individuals who undergo screening for Chronic Kidney Disease (CKD)
timeFrame: 6 months
Secondary outcomes:
measure: New diagnosis of CKD (Chronic Kidney Disease)
timeFrame: 5 years
measure: Anti-hyperintensive therapy
timeFrame: 5 years
measure: Renin angiotensin aldosterone inhibitor blockade treatment
timeFrame: 5 years
measure: Sodium Glucose Cotransporter 2 (SGLT2) inhibition treatment
timeFrame: 5 years
measure: Mineral corticoid receptor antagonist treatment
timeFrame: 5 years
measure: Statins treatment
timeFrame: 5 years
measure: Anti-platelet agents treatment
timeFrame: 5 years
measure: Hospitalizations for diseases
timeFrame: 5 years
measure: The number of antihypertensive medications
timeFrame: 5 years
measure: Change in estimated Glomerular Filtration Rate, urine albumin to creatinine ratio, kidney failure risk equation measurements
timeFrame: 5 years
measure: estimated Glomerular Filtration Rate slope
timeFrame: 5 years
measure: Number of individuals with 40 % decline in estimated Glomerular Filtration Rate
timeFrame: 5 years
measure: Number of individuals with kidney failure
timeFrame: 5 years
measure: Number of individuals on dialysis
timeFrame: 5 years
measure: Number of individuals to receive kidney transplant
timeFrame: 5 years
measure: Number of individuals who have died
timeFrame: 5 years
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Chronic Disease Innovation Centre
Study officials:
affiliation: University of Manitoba
name: David Collister, MD, PhD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References: