Chronic Kidney DiseasesCKD Safety-NetNCT07724288
Designing and Implementing a Safety Net Surveillance Program for High Risk CKD
A study testing Letter to participants in people with Chronic Kidney Diseases, run by University of Manitoba at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Diseases
- What is being tested?
- Letter to participants
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 972 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2026to Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- A previous billing claim from a nephrologist
- Receiving palliative care within 3 months of randomization
- Previous history of dialysis and/or kidney transplantation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
University of Manitoba
Winnipeg, Manitoba, R3T 2N2
Oksana Harasemiw, MSc, 1-204-632-3541, oharasemiw@sogh.mb.ca
About this study
Official title: 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.
Read the 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).
- Conditions
- Chronic Kidney Diseases
- Being tested
- Letter to participants
- Keywords
- Chronic Kidney Disease, Kidney Diseases, Access to care, Secondary Prevention
- Medical subject headings
- Renal Insufficiency, Chronic, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Letter to participantsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of kidney failure and all-cause mortality
Kidney failure defined as dialysis, kidney transplantation. Collected using provincial administrative databases accessed through the MCHP
Measured: within 12 months of letter mailout
Secondary outcomes (8)
Attendance at a clinic visit with a nephrologist
Collected using provincial administrative databases accessed through the MCHP
Measured: 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
- All-cause mortality
Measured: within 12 months of letter mailout
Alll-cause hospitalizations and emergency room visits
Collected using provincial administrative databases accessed through the MCHP
Measured: 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
Measured: within 12 months of letter mailout
eGFR (mL/min/1.73 m²)
Collected using provincial administrative databases accessed through the MCHP
Measured: within 12 months of letter mailout
Urine albumin-to-creatinine ratio (mg/mmol)
Collected using provincial administrative databases accessed through the MCHP
Measured: within 12 months of letter mailout
2-year Kidney Failure Risk Equation Score
Collected using provincial administrative databases accessed through the MCHP
Measured: 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
Measured: within 12 months of letter mailout
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study startAug 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 972 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Can-SOLVE CKD Network, Seven Oaks Hospital Chronic Disease Innovation Centre
- Responsible party
- Principal investigator, Navdeep Tangri, University of Manitoba
- Investigators
- Navdeep Tangri, MD, PhD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07724288
- Sponsor's protocol ID
- HS25871 (H2023:052)
- Acronym
- CKD Safety-Net
- Status last verified
- Aug 2026
- First submitted
- 20 Jul 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Designing and Implementing a Safety Net Surveillance Program for High Risk CKD (CKD Safety Net)
- ClinicalTrials.gov ID
- NCT07724288
- Acronym / sponsor ID
- CKD Safety-Net / HS25871 (H2023:052)
- Conditions
- Chronic Kidney Diseases
- Keywords
- Chronic Kidney Disease, Kidney Diseases, Access to care, Secondary Prevention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 972 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Can-SOLVE CKD Network, Seven Oaks Hospital Chronic Disease Innovation Centre
- Study start
- Aug 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 24 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Other: Letter to participantsIndividuals 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (3 listed)
- A previous billing claim from a nephrologist
- Receiving palliative care within 3 months of randomization
- Previous history of dialysis and/or kidney transplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Letter to participantsIndividuals 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. | Other | Intervention Arm |
Primary outcome
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
8 secondary outcomes
Attendance at a clinic visit with a nephrologist
Time frame: within 12 months of letter mailout
Individual components of the composite primary outcome
Time frame: within 12 months of letter mailout
Alll-cause hospitalizations and emergency room visits
Time frame: within 12 months of letter mailout
Major adverse cardiac events
Time frame: within 12 months of letter mailout
eGFR (mL/min/1.73 m²)
Time frame: within 12 months of letter mailout
Urine albumin-to-creatinine ratio (mg/mmol)
Time frame: within 12 months of letter mailout
2-year Kidney Failure Risk Equation Score
Time frame: 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
Time frame: within 12 months of letter mailout
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Navdeep Tangri, MD, PhD principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Letter to participants in people with Chronic Kidney Diseases, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Oksana Harasemiw, MSc (204-632-3541, oharasemiw@sogh.mb.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of kidney failure and all-cause mortality (time frame: within 12 months of letter mailout). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.