ClinicalTrials.gg
Not yet recruitingNCT07724288CKD Safety-NetUpdated Aug 17, 2026

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

An interventional study of Letter to participants in Chronic Kidney Diseases, sponsored by University of Manitoba. Not yet recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-17.

Sponsored by University of Manitoba · Not applicable, Interventional, and Screening

Phase
Not applicable
Study type
Interventional
Enrollment
972
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 10 studies in Renal Insufficiency, Chronic by University of Manitoba — 5 open to participants now, 5 under way, none of them phase 3. Renal Insufficiency, Chronic · University of Manitoba.

Started
2026
the only one that year
No phase
8 of 10
4 open now
Registered
10th of 10
by date

Among the 10 studies in Renal Insufficiency, Chronic by University of Manitoba, this one is the only one that started in 2026, is one of 8 with no phase, and was the 10th registered.

By phase

10 studies; the count open now beside each. This study's row is marked.

No phasethis study8 · 4 open
Observational2 · 1 open

By the year they started

First in 2014; this study’s year is marked. 1 started in 2026.

Size and results

Median enrollment 200 across the 8 interventional studies, 1,670 across the 2 observational. Of the 5 that completed or were terminated, 0 (0%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 10 studies in Renal Insufficiency, Chronic by University of Manitoba, or all of them as a file.
02

Study 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.

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).

03

Conditions studied

  • Chronic Kidney Diseases

Keywords

  • Chronic Kidney Disease
  • Kidney Diseases
  • Access to care
  • Secondary Prevention
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age > 18 years old
  • Resident of Manitoba / has Manitoba Health coverage
  • Either:
  • 2 \<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

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
972 participants (estimated)

Study arms

  • 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

  • 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.

Interventions

  • OtherLetter to participants

    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.

06

What researchers measure

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

    Time frame: within 12 months of letter mailout

Secondary outcomes

  1. Attendance at a clinic visit with a nephrologist

    Collected using provincial administrative databases accessed through the MCHP

    Time frame: within 12 months of letter mailout

  2. 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

    Time frame: within 12 months of letter mailout

  3. Alll-cause hospitalizations and emergency room visits

    Collected using provincial administrative databases accessed through the MCHP

    Time frame: within 12 months of letter mailout

  4. 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

    Time frame: within 12 months of letter mailout

  5. eGFR (mL/min/1.73 m²)

    Collected using provincial administrative databases accessed through the MCHP

    Time frame: within 12 months of letter mailout

  6. Urine albumin-to-creatinine ratio (mg/mmol)

    Collected using provincial administrative databases accessed through the MCHP

    Time frame: within 12 months of letter mailout

  7. 2-year Kidney Failure Risk Equation Score

    Collected using provincial administrative databases accessed through the MCHP

    Time frame: within 12 months of letter mailout

  8. 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

    Time frame: within 12 months of letter mailout

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Aug 2026; primary completion for Jun 2027, 10 months later.

Of 576 non-industry interventional studies with no phase under Renal Insufficiency, Chronic, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 45. This study's planned 10 months is below that.

Counting every sponsor, half of 616 studies reached it within 23 months; a quarter within 10 and three quarters within 45.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 20, 2026
First posted
Jul 24, 2026
StartEst.
Aug 2026
Primary completionEst.
Jun 2027
CompletionEst.
Mar 2028
Last update
Aug 17, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07724288
Collaborators
Can-SOLVE CKD Network, Seven Oaks Hospital Chronic Disease Innovation Centre
Responsible party
Navdeep Tangri (Professor of Medicine, University of Manitoba) — Principal investigator
First posted
Jul 24, 2026
Start date
Aug 2026 (estimated)
Primary completion
Jun 2027 (estimated)
Completion
Mar 2028 (estimated)
Last update
Aug 17, 2026

Study contacts

Oksana Harasemiw, MSc
Contact
oharasemiw@sogh.mb.ca
204-632-3541
Navdeep Tangri, MD, PhD
principal investigator · University of Manitoba

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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