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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Kidney Diseases
• Intervention / Treatment: Other: Letter to participants

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Estimated): 972
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Oksana Harasemiw, MSc; Phone Number: 204-632-3541; Email: oharasemiw@sogh.mb.ca

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3T 2N2
      • University of Manitoba
      • Contact: Oksana Harasemiw, MSc; Phone Number: 1-204-632-3541; Email: oharasemiw@sogh.mb.ca

Participation Criteria

Eligibility Criteria

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

Description

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

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
Experimental: Intervention Arm; Individuals randomized to the intervention group will receive a letter from MCHP. A follow-up reminder letter will be sent at 3 months in individuals that do not respond to the initial invitation. Individuals who respond to the letter by contacting the study team will be scheduled for an initial clinic appointment with a Clinical Assistant/Nephrologist, and will begin receiving routine clinical care thereafter, as per local clinical guidelines.	Other: Letter to participants; 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.
No Intervention: Control Arm; Individuals randomized to the control group will continue receiving usual care without any intervention from the study team. Their outcomes will be ascertained using de-identified administrative data. If the trial is successful, indivdiuals in the control group will be contacted for follow-up with a nephrologist in the same manner (i.e. through a mailout letter) as the intervention group was.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite of kidney failure and all-cause mortality	Kidney failure defined as dialysis, kidney transplantation. Collected using provincial administrative databases accessed through the MCHP	within 12 months of letter mailout

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Attendance at a clinic visit with a nephrologist	Collected using provincial administrative databases accessed through the MCHP	within 12 months of letter mailout
Individual components of the composite primary outcome	Kidney failure (dialysis and/or transplantation) and all-cause mortality. Collected using provincial administrative databases accessed through the MCHP o All-cause mortality	within 12 months of letter mailout
Alll-cause hospitalizations and emergency room visits	Collected using provincial administrative databases accessed through the MCHP	within 12 months of letter mailout
Major adverse cardiac events	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	within 12 months of letter mailout
eGFR, urine ACR, KFRE at follow-up	Collected using provincial administrative databases accessed through the MCHP	within 12 months of letter mailout
The proportion of individuals starting a new prescription of RAAS inhibitors, SGLT2i, Ns-MRAs, Statins, and GLP-1 agonists	Collected using provincial administrative databases accessed through the MCHP	within 12 months of letter mailout

Collaborators and Investigators

• Sponsor: University of Manitoba
• Collaborators: Seven Oaks Hospital Chronic Disease Innovation Centre; Can-SOLVE CKD Network
• Investigators: Principal Investigator: Navdeep Tangri, MD, PhD, University of Manitoba

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: July 20, 2026
• First Submitted That Met QC Criteria: July 20, 2026
• First Posted (Actual): July 24, 2026

Study Record Updates

• Last Update Posted (Actual): July 24, 2026
• Last Update Submitted That Met QC Criteria: July 20, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Access to care; Chronic Kidney Disease; Kidney Diseases; Secondary Prevention
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: HS25871 (H2023:052)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No