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Enrolling by Invitation

NCT Number: NCT06223750

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.

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Key information

Conditions

Kidney Disease, Chronic Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chronic Disease Innovation Centre

Winnipeg, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

population-based screening for chronic kidney disease

Other

Randomized controlled trial that uses an integrated health platform for eligibility and outcome assessments

Primary outcomes

  1. The proportion of individuals who undergo screening for Chronic Kidney Disease (CKD)

    Time frame: 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 outcomes

  1. New diagnosis of CKD (Chronic Kidney Disease)

    Time frame: 5 years

    The proportion of individuals with a new diagnosis of CKD by estimated glomerular filtration rate (eGFR) or albuminuria for each screening strategy

  2. Anti-hyperintensive therapy

    Time frame: 5 years

    The proportion of individuals treated with anti-hyperintensive therapy for each screening strategy

  3. Renin angiotensin aldosterone inhibitor blockade treatment

    Time frame: 5 years

    The proportion of individuals treated with renin angiotensin aldosterone inhibitor blockade for each screening strategy

  4. Sodium Glucose Cotransporter 2 (SGLT2) inhibition treatment

    Time frame: 5 years

    The proportion of individuals treated with Sodium Glucose Cotransporter 2 (SGLT2) inhibition for each screening strategy

  5. Mineral corticoid receptor antagonist treatment

    Time frame: 5 years

    The proportion of individuals treated with a mineral corticoid receptor antagonist for each screening strategy

  6. Statins treatment

    Time frame: 5 years

    The proportion of individuals treated with statins for each screening strategy

  7. Anti-platelet agents treatment

    Time frame: 5 years

    The proportion of individuals treated with anti-platelet agents for each screening strategy

  8. Hospitalizations for diseases

    Time frame: 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

  9. The number of antihypertensive medications

    Time frame: 5 years

    The number of antihypertensive medications per individual for each screening strategy

  10. Change in estimated Glomerular Filtration Rate, urine albumin to creatinine ratio, kidney failure risk equation measurements

    Time frame: 5 years

    Change in estimated Glomerular Filtration Rate, urine albumin to creatinine ratio, kidney failure risk equation measurements for each individual

  11. estimated Glomerular Filtration Rate slope

    Time frame: 5 years

    Tracking changes in estimated Glomerular Filtration Rate over time indicates progression of chronic kidney disease for each individual

  12. Number of individuals with 40 % decline in estimated Glomerular Filtration Rate

    Time frame: 5 years

    Number of individuals with 40 % decline in estimated Glomerular Filtration Rate

  13. Number of individuals with kidney failure

    Time frame: 5 years

    Number of individuals with kidney failure

  14. Number of individuals on dialysis

    Time frame: 5 years

    Number of individuals on dialysis

  15. Number of individuals to receive kidney transplant

    Time frame: 5 years

    Number of individuals to receive kidney transplant

  16. Number of individuals who have died

    Time frame: 5 years

    Number of individuals who have died

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Collaborators

  • 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

Registry information

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Jan 25, 2024
Registry last updated
Sep 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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