Kidney Disease, ChronicNCT06223750
Virtual Kidney Check and Follow-up
A study testing population-based screening for chronic kidney disease in people with Kidney Disease, Chronic, run by University of Manitoba at 1 site in Canada.
Trial summary
The goal of this clinical trial is to determine the most effective way to complete population-based screening for chronic kidney disease (CKD) in First Nations adults in Manitoba. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Disease, Chronic
- What is being tested?
- population-based screening for chronic kidney disease
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,356 participants
- Where
- 1 siteCanada
- Study dates
- 1 Nov 2024to Apr 2029
- 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
- Resident of Manitoba
- First Nations
- Urban, rural or remote location
Who cannot join
- Kidney failure (dialysis or transplant)
- chronic kidney disease (estimated Glomerular Filtration Rate <60 milliliter/1.73square meter for 3 months)
- Screening for chronic kidney disease with estimated Glomerular Filtration Rate or Albumin to Creatinine ratio in the last 2 years
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The goal of this clinical trial is to determine the most effective way to complete population-based screening for chronic kidney disease (CKD) in First Nations adults in Manitoba. The main questions it aims to answer are:
- To identify chronic kidney disease in First Nations adults in Manitoba
- To risk stratify patients as low, moderate and high risk of kidney failure and organize active surveillance by risk category
- To initiate treatments to prevent to progression of chronic kidney disease in individuals at risk of kidney failure
Read more
Participants will be randomized to:
- Patient contact via mail with a letter and laboratory requisition for serum creatinine and urine Albumin Creatinine Ratio
- Patient and primary care network contact via mail with a letter but no laboratory requisition
The primary outcome is the difference between groups in the proportion of individuals who undergo screening for chronic kidney disease within 6 months.
- Conditions
- Kidney Disease, Chronic
- Being tested
- population-based screening for chronic kidney disease
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
population-based screening for chronic kidney diseaseOther
Randomized controlled trial that uses an integrated health platform for eligibility and outcome assessments
| Study group | Role | What they receive |
|---|---|---|
| Patient contact via mail with a letter and laboratory requisition | Other | Patient contact via mail with a letter and laboratory requisition for serum creatinine and urine albumin to creatinine ratio Receives: Other: population-based screening for chronic kidney disease |
| Patient and primary care network contact via mail with a letter but no laboratory requisition | Other | Not described Receives: Other: population-based screening for chronic kidney disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of individuals who undergo screening for Chronic Kidney Disease (CKD)
The proportion of individuals screened for Chronic Kidney Disease using one screening strategy is compared to the proportion of individuals screened using the other screening strategy.
Measured: 6 months
Secondary outcomes (16)
New diagnosis of CKD (Chronic Kidney Disease)
The proportion of individuals with a new diagnosis of CKD by estimated glomerular filtration rate (eGFR) or albuminuria for each screening strategy
Measured: 5 years
Anti-hyperintensive therapy
The proportion of individuals treated with anti-hyperintensive therapy for each screening strategy
Measured: 5 years
Renin angiotensin aldosterone inhibitor blockade treatment
The proportion of individuals treated with renin angiotensin aldosterone inhibitor blockade for each screening strategy
Measured: 5 years
Sodium Glucose Cotransporter 2 (SGLT2) inhibition treatment
The proportion of individuals treated with Sodium Glucose Cotransporter 2 (SGLT2) inhibition for each screening strategy
Measured: 5 years
Mineral corticoid receptor antagonist treatment
The proportion of individuals treated with a mineral corticoid receptor antagonist for each screening strategy
Measured: 5 years
Statins treatment
The proportion of individuals treated with statins for each screening strategy
Measured: 5 years
Anti-platelet agents treatment
The proportion of individuals treated with anti-platelet agents for each screening strategy
Measured: 5 years
Hospitalizations for diseases
The proportion of individuals treated with hospitalizations for acute coronary syndrome, peripheral vascular disease, cerebrovascular disease or heart failure rate. Urine albumin to creatinine ratio, kidney failure risk equation (KFRE) measurements are also calculated for each screening strategy
Measured: 5 years
The number of antihypertensive medications
The number of antihypertensive medications per individual for each screening strategy
Measured: 5 years
Change in estimated Glomerular Filtration Rate, urine albumin to creatinine ratio, kidney failure risk equation measurements
Change in estimated Glomerular Filtration Rate, urine albumin to creatinine ratio, kidney failure risk equation measurements for each individual
Measured: 5 years
estimated Glomerular Filtration Rate slope
Tracking changes in estimated Glomerular Filtration Rate over time indicates progression of chronic kidney disease for each individual
Measured: 5 years
Number of individuals with 40 % decline in estimated Glomerular Filtration Rate
Number of individuals with 40 % decline in estimated Glomerular Filtration Rate
Measured: 5 years
Number of individuals with kidney failure
Number of individuals with kidney failure
Measured: 5 years
Number of individuals on dialysis
Number of individuals on dialysis
Measured: 5 years
Number of individuals to receive kidney transplant
Number of individuals to receive kidney transplant
Measured: 5 years
Number of individuals who have died
Number of individuals who have died
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start1 Nov 2024
- Primary completionApr 2029 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Disease, ChronicStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 3,356 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Boehringer Ingelheim, Research Manitoba, Manitoba Health, Seniors and Long-Term Care, Province of Manitoba, First Nations Health and Social Secretariat of Manitoba, Shared Health Manitoba, Seven Oaks General Hospital
- Responsible party
- Sponsor
- Investigators
- David Collister, MD, PhD, FRCPC, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06223750
- Sponsor's protocol ID
- HS24845 (H2021:170)
- Status last verified
- Aug 2025
- First submitted
- 19 Dec 2023
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Kidney Check and Follow-up
- ClinicalTrials.gov ID
- NCT06223750
- Acronym / sponsor ID
- HS24845 (H2021:170)
- Conditions
- Kidney Disease, Chronic
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 3,356 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Boehringer Ingelheim, Research Manitoba, Manitoba Health, Seniors and Long-Term Care, Province of Manitoba, First Nations Health and Social Secretariat of Manitoba, Shared Health Manitoba, Seven Oaks General Hospital
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- Apr 2029 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 25 Jan 2024 (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 goal of this clinical trial is to determine the most effective way to complete population-based screening for chronic kidney disease (CKD) in First Nations adults in Manitoba. The main questions it aims to answer are:
- To identify chronic kidney disease in First Nations adults in Manitoba
- To risk stratify patients as low, moderate and high risk of kidney failure and organize active surveillance by risk category
- To initiate treatments to prevent to progression of chronic kidney disease in individuals at risk of kidney failure
Participants will be randomized to:
- Patient contact via mail with a letter and laboratory requisition for serum creatinine and urine Albumin Creatinine Ratio
- Patient and primary care network contact via mail with a letter but no laboratory requisition
The primary outcome is the difference between groups in the proportion of individuals who undergo screening for chronic kidney disease within 6 months.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient contact via mail with a letter and laboratory requisition | Other | Other: population-based screening for chronic kidney diseasePatient contact via mail with a letter and laboratory requisition for serum creatinine and urine albumin to creatinine ratio |
| Patient and primary care network contact via mail with a letter but no laboratory requisition | Other | Other: population-based screening for chronic kidney disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age>= 18 years
- Resident of Manitoba
- First Nations
- Urban, rural or remote location
Key exclusion criteria (3 listed)
- Kidney failure (dialysis or transplant)
- chronic kidney disease (estimated Glomerular Filtration Rate <60 milliliter/1.73square meter for 3 months)
- Screening for chronic kidney disease with estimated Glomerular Filtration Rate or Albumin to Creatinine ratio in the last 2 years
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 |
|---|---|---|
| population-based screening for chronic kidney diseaseRandomized controlled trial that uses an integrated health platform for eligibility and outcome assessments | Other | Patient and primary care network contact via mail with a letter but no laboratory requisition, Patient contact via mail with a letter and laboratory requisition |
Primary outcome
The proportion of individuals who undergo screening for Chronic Kidney Disease (CKD)
Time frame: 6 months
The proportion of individuals screened for Chronic Kidney Disease using one screening strategy is compared to the proportion of individuals screened using the other screening strategy.
16 secondary outcomes
New diagnosis of CKD (Chronic Kidney Disease)
Time frame: 5 years
Anti-hyperintensive therapy
Time frame: 5 years
Renin angiotensin aldosterone inhibitor blockade treatment
Time frame: 5 years
Sodium Glucose Cotransporter 2 (SGLT2) inhibition treatment
Time frame: 5 years
Mineral corticoid receptor antagonist treatment
Time frame: 5 years
Statins treatment
Time frame: 5 years
Anti-platelet agents treatment
Time frame: 5 years
Hospitalizations for diseases
Time frame: 5 years
The number of antihypertensive medications
Time frame: 5 years
Change in estimated Glomerular Filtration Rate, urine albumin to creatinine ratio, kidney failure risk equation measurements
Time frame: 5 years
estimated Glomerular Filtration Rate slope
Time frame: 5 years
Number of individuals with 40 % decline in estimated Glomerular Filtration Rate
Time frame: 5 years
Number of individuals with kidney failure
Time frame: 5 years
Number of individuals on dialysis
Time frame: 5 years
Number of individuals to receive kidney transplant
Time frame: 5 years
Number of individuals who have died
Time frame: 5 years
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 2 Sep 2025.
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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.
David Collister, MD, PhD, FRCPC 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 population-based screening for chronic kidney disease in people with Kidney Disease, Chronic, 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 4 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: enrolling by invitation, as of the sponsor's last update on 2 Sep 2025. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of individuals who undergo screening for Chronic Kidney Disease (CKD) (time frame: 6 months). 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 2 Sep 2025.