Virtual Kidney Check and Follow-up

Kidney Disease, Chronic Clinical Trial

Official title:

Virtual Kidney Check and Follow-up

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06223750
• Other study ID #: HS24845 (H2021:170)
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2024
• Est. completion date: April 2029

Study information

• Verified date: June 2024
• Source: University of Manitoba
• Contact: Maria James, M.Sc
• Phone: 2046323541
• Email: mjames4[@]sogh.mb.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 3356
• Est. completion date: April 2029
• Est. primary completion date: April 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Disease, Chronic
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Other:
• population-based screening for chronic kidney disease
Randomized controlled trial that uses an integrated health platform for eligibility and outcome assessments

Locations

Country	Name	City	State
n/a

Sponsors (7)

Lead Sponsor	Collaborator
University of Manitoba	Boehringer Ingelheim, First Nations Health and Social Secretariat of Manitoba, Manitoba Health, Seniors and Long-Term Care, Province of Manitoba, Research Manitoba, Seven Oaks General Hospital, Shared Health Manitoba

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Anti-hyperintensive therapy	The proportion of individuals treated with anti-hyperintensive therapy for each screening strategy	5 years
Secondary	Renin angiotensin aldosterone inhibitor blockade treatment	The proportion of individuals treated with renin angiotensin aldosterone inhibitor blockade for each screening strategy	5 years
Secondary	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
Secondary	Mineral corticoid receptor antagonist treatment	The proportion of individuals treated with a mineral corticoid receptor antagonist for each screening strategy	5 years
Secondary	Statins treatment	The proportion of individuals treated with statins for each screening strategy	5 years
Secondary	Anti-platelet agents treatment	The proportion of individuals treated with anti-platelet agents for each screening strategy	5 years
Secondary	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
Secondary	The number of antihypertensive medications	The number of antihypertensive medications per individual for each screening strategy	5 years
Secondary	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
Secondary	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
Secondary	Number of individuals with 40 % decline in estimated Glomerular Filtration Rate	Number of individuals with 40 % decline in estimated Glomerular Filtration Rate	5 years
Secondary	Number of individuals with kidney failure	Number of individuals with kidney failure	5 years
Secondary	Number of individuals on dialysis	Number of individuals on dialysis	5 years
Secondary	Number of individuals to receive kidney transplant	Number of individuals to receive kidney transplant	5 years
Secondary	Number of individuals who have died	Number of individuals who have died	5 years