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

NCT07724288 | Not Yet Recruiting DMC

• 1 other identifier: HS25871 (H2023:052)
• Study Type: interventional
• Target: 972
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Kidney Diseases

Keywords

Chronic Kidney Disease; Kidney Diseases; Access to care; Secondary Prevention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Attendance at a clinic visit with a nephrologist

  within 12 months of letter mailout

• Individual components of the composite primary outcome

  within 12 months of letter mailout

• Alll-cause hospitalizations and emergency room visits

  within 12 months of letter mailout

• Major adverse cardiac events

  within 12 months of letter mailout

• eGFR, urine ACR, KFRE at follow-up

  within 12 months of letter mailout

Study Arms (2)

Intervention Arm

EXPERIMENTAL

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

Control Arm

NO INTERVENTION

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.

Interventions

Letter to participants OTHER

Individuals randomized to the intervention group will received a direct mailing consisting of: 1. 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 2. 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.

Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years old
• Resident of Manitoba / has Manitoba Health coverage
• Either:
• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Seven Oaks Hospital Chronic Disease Innovation Centre: collaborator
• University of Manitoba: lead
• Can-SOLVE CKD Network: collaborator

Study Sites (1)

University of Manitoba

Winnipeg, Manitoba, R3T 2N2, Canada

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Kidney Diseases

Condition Hierarchy (Ancestors)

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

Study Officials

• Navdeep Tangri, MD, PhD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Oksana Harasemiw, MSc

CONTACT

204-632-3541; oharasemiw@sogh.mb.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the intervention, blinding of participants, care providers, and investigators is not possible. Outcome assessors and analysts will be blinded
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Model Details: Eligible participants will be randomly allocated to either the control group or the intervention group (mailing letter). The sequence will be randomly generated by a Data Analyst, and the allocation list will be concealed within the MCHP Virtual Private Network. Allocation will be in an equal 1:1 ratio for each sequence, stratified by age (\<65 years of age, ≥65 years of age), sex (male, female), location (urban, rural).

Study Record Dates

• First Submitted: July 20, 2026
• First Posted: July 24, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: July 24, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)