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NCT Number: NCT07724288

Designing and Implementing a Safety Net Surveillance Program for High Risk CKD

The objective of this initiative is to develop and evaluate a risk-based, provincial public health screening program for chronic kidney disease (CKD) that provides proactive care for adults at high-risk of kidney failure who have not previously been referred to a nephrologist, through risk stratification, triage, education, and follow-up.

Overall, we aim to demonstrate that an integrated risk-based provincial public health screening program for CKD is feasible, and improves identification of high-risk individuals, subsequently creating a model of care that can be adopted by other jurisdictions.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

A Parallel Group Randomized Controlled Trial will be conducted implementing our previously developed laboratory-based risk prediction models into a new provincial CKD surveillance system. Using administrative data through the Manitoba Centre for Health Policy (MCHP), we will identify all high-risk adults with CKD in Manitoba who had appropriate laboratory testing for CKD (i.e. at least 2 eGFR tests) completed in the 2 most recent years of available data, and who subsequently met nephrology referral criteria, but were never referred to a nephrologist. All individuals identified will be randomized to either: (1) receive a letter describing their results and an invitation for a consult with a clinical assistant and a nephrologist at Seven Oaks General Hospital, or (2) usual care (i.e. no letter and referral to nephrology based on their primary care physician/circle of care).

The program will support the integration of risk-based care at a population-level, in turn providing opportunities that will prompt changes in further investigation, treatment, referral for education, and inform a personalized medicine approach for patient-provider discussions regarding prognosis.

All outcomes will be collected using provincial administrative databases accessed through the Manitoba Centre for Health Policy (MCHP).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age > 18 years old
  • Resident of Manitoba / has Manitoba Health coverage
  • Either:
  • 2 eGFR <15 mL/min/1.73m2 tests within a 2-year timeframe or
  • A greater than 10% 2-year kidney failure risk (at 2 separate timepoints within a 2-year timeframe) - using the 4-variable or 3-variable 2-year Kidney Failure Risk Equation (KFRE)

Exclusion criteria

  • A previous billing claim from a nephrologist
  • Receiving palliative care within 3 months of randomization
  • Previous history of dialysis and/or kidney transplantation

Treatment and study plan

Letter to participants

Other

Individuals randomized to the intervention group will received a direct mailing consisting of:

  • A letter explaining the purpose of the study and the benefits of screening for CKD, with contact information for the study team at Seven Oaks General Hospital / Chronic Disease Innovation Centre, who they may contact to receive further information and to book a follow-up appointment with a Clinical Assistant/Nephrologist
  • A brief fact sheet on CKD A follow-up reminder letter will be sent at 3 months in individuals that do not respond to the initial invitation.

Primary outcomes

  1. Composite of kidney failure and all-cause mortality

    Time frame: within 12 months of letter mailout

    Kidney failure defined as dialysis, kidney transplantation. Collected using provincial administrative databases accessed through the MCHP

Secondary outcomes

  1. Attendance at a clinic visit with a nephrologist

    Time frame: within 12 months of letter mailout

    Collected using provincial administrative databases accessed through the MCHP

  2. Individual components of the composite primary outcome

    Time frame: within 12 months of letter mailout

    Kidney failure (dialysis and/or transplantation) and all-cause mortality. Collected using provincial administrative databases accessed through the MCHP

    o All-cause mortality

  3. Alll-cause hospitalizations and emergency room visits

    Time frame: within 12 months of letter mailout

    Collected using provincial administrative databases accessed through the MCHP

  4. Major adverse cardiac events

    Time frame: within 12 months of letter mailout

    Major adverse cardiac events (MACE+, defined as myocardial infarction (MI), ischemic stroke, incident heart failure (a new heart failure diagnosis in a patient without evidence of heart failure at baseline), heart failure admission (an inpatient admission with a concurrent diagnosis of heart failure in patients with a history of heart failure), or cardiovascular death (death within the same or next calendar month as discharge from an inpatient hospital stay involving a diagnosis code for heart failure, stroke, or MI)). Collected using provincial administrative databases accessed through the MCHP

  5. eGFR, urine ACR, KFRE at follow-up

    Time frame: within 12 months of letter mailout

    Collected using provincial administrative databases accessed through the MCHP

  6. The proportion of individuals starting a new prescription of RAAS inhibitors, SGLT2i, Ns-MRAs, Statins, and GLP-1 agonists

    Time frame: within 12 months of letter mailout

    Collected using provincial administrative databases accessed through the MCHP

Study contacts

Contact information is provided by the study sponsor or research team.

Oksana Harasemiw, MSc

CONTACT

[email protected]

204-632-3541

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Collaborators

  • Can-SOLVE CKD Network
  • Seven Oaks Hospital Chronic Disease Innovation Centre

Registry information

Official study title

Designing and Implementing a Safety Net Surveillance Program for High Risk CKD (CKD Safety Net)

Acronym: CKD Safety-Net

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jul 24, 2026
Registry last updated
Jul 24, 2026

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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