Chronic Kidney DiseaseNCT03595267
Kidney Check: Diabetes, Blood Pressure & Kidney Health Checks & Care in Indigenous Communities.
An observational study of Chronic Kidney Disease and Diabetes, run by University of Manitoba at 3 sites in Canada.
Trial summary
Faced with limited access to preventative health care services, Indigenous people living in rural and remote communities are at a higher risk of Chronic Kidney Disease (CKD) and kidney failure, when compared to the general population. Read more about this study
- Who is it for?
- Ages 10 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Disease, Diabetes, Hypertension
- What is being tested?
- Point-of-care screening
- How many people
- 2,500 participants
- Where
- 3 sitesCanada
- Study dates
- 1 Oct 2019to Dec 2025
- Phase
- Observational
- 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 10 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Indigenous communities in rural (accessible by road), and remote (accessible by flying-in, or winter ice roads) areas of Manitoba, British Columbia, Alberta, Saskatchewan and Ontario will be targeted for the screening program.
Who may be able to join
- All individuals aged 10 years old - 80 years old will be recruited for screening, regardless of known CKD risk factors, such as diabetes, elevated blood pressure, or family history of kidney disease.
Who cannot join
- None.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada3 sites, 3 recruiting
- Recruiting
Alberta Health Services
Calgary, Alberta, T2W1S7
Deenaz Zaidi, BSc, deenaz@ualberta.ca
- Recruiting
First Nations Research and Knowledge Exchange
West Vancouver, British Columbia, V7T 1A2
Catherine Turner, catherine.turner@fnha.ca
- Enrolling by invitation
Chronic Disease Innovation Centre
Winnipeg, Manitoba, R2V 3M3
About this study
Official title: Optimal Approaches to Chronic Kidney Disease Case Finding in Indigenous Communities
Faced with limited access to preventative health care services, Indigenous people living in rural and remote communities are at a higher risk of Chronic Kidney Disease (CKD) and kidney failure, when compared to the general population. The goal of this project is to perform point-of-care testing for CKD and its risk factors, including diabetes and high blood pressure, for individuals residing in rural and remote Indigenous communities across the Canadian provinces of Manitoba, British Columbia, Alberta, Saskatchewan, and Ontario. In addition to providing individuals with information about their risk of developing CKD, as well as providing tailored treatment plans, this study will help provide evidence to develop a permanent CKD surveillance system in all Indigenous communities across Canada, consequently decreasing the burden of CKD and kidney failure in these communities.
Read the detailed description
Compared to the general population, Indigenous people disproportionately suffer from higher rates of diabetes, hypertension, obesity, and chronic kidney disease (CKD), when compared to their non-Indigenous counterparts. However, rates of these morbidities are greatest for Indigenous individuals living in rural and remote areas, where social inequalities such as poverty and poor access to services - in particular reduced access to primary care and nephrology specialists - are the most the salient.
If caught and treated early in its course, kidney failure is often preventable, especially for those at the highest risk of progression. However, CKD is often unrecognizable and asymptomatic until it is in its later stages, when the chances of preventing kidney failure are limited. Therefore, in order to administer targeted therapeutic interventions, early identification and stratification of those at highest risk of CKD are urgently needed. Screening programs using state of the art point-of-care testing equipment with blood and urine samples can test for CKD both quickly and accurately. While general population-based screening have not been found to be beneficial, targeted screening directed toward high-risk patients with diabetes and high blood pressure, or high-risk populations known to progress rapidly or have limited access to primary health care, are cost-effective. In particular, research has shown that the cost utility of one-off, point-of-care screening and treatment for CKD in rural and remote Indigenous communities is highly cost-effective when compared to usual care provided in these geographic areas.
The goal of this project is to develop a platform that will enable the early diagnosis of Indigenous adults and children with CKD living in Indigenous communities across Canada, and lead to treatment and follow up care targeted to each individual's risk of kidney failure. By developing mobile mass screening and prevention initiatives in adults and children for the prevention of CKD and kidney failure, appropriate treatment and follow-up will continue, and rates of CKD progression will decline, with fewer patients reaching kidney failure requiring dialysis. In addition, this project will further demonstrate the benefits of front line surveillance, risk prediction and treatment, and lead to novel insights regarding prognosis, and the factors driving kidney disease in Indigenous communities, ultimately serving as the gold-standard model for delivery of kidney care across Canada.
- Conditions
- Chronic Kidney Disease, Diabetes, Hypertension
- Being tested
- Point-of-care screening
- Keywords
- Indigenous Canadians, Screening Study
- Medical subject headings
- Renal Insufficiency, Chronic, Diabetes Mellitus, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Point-of-care screeningOther
After consent is obtained, a registered nurse will administer a demographic questionnaire, collecting the participant's personal health number, age, gender, date of birth, and name of community. Physical data including height, weight, and blood pressure will also be collected. A blood sample and a urine sample will be taken, with point-of-care testing being performed during the screening appointment to allow for results of the testing to be received and discussed with each patient at the time of the appointment. After screening, to ensure a "closed loop" system of care, patients at the highest risk of kidney failure will be referred to a nephrologist, while those at lower risk will be referred to their primary care provider with specific treatment and re-testing recommendations.
| Study group | Role | What they receive |
|---|---|---|
| Rural and Remote Indigenous Communities | Point-of-care screening for Chronic Kidney Disease, Diabetes, and Hypertension will be administered in rural and remote communities in Manitoba, British Columbia, Alberta, Saskatchewan, and Ontario. Receives: Other: Point-of-care screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarkers of Kidney Function
eGFR; Albuminuria; Urine ACR
Measured: 1 day (At time of screening)
Diabetes
Defined as a Hemoglobin A1c => 6.5%
Measured: 1 day (At time of screening)
Elevated Blood Pressure
Defined as a Systolic Blood Pressure > 140 mmHg, or Diastolic Blood Pressure > 90mmHg
Measured: 1 day (At time of screening)
Kidney Failure Risk
Measured using the Kidney Failure Risk Equation
Measured: 1 day (At time of screening)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2018
- Study start1 Oct 2019
- Primary completionSep 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Canadians Seeking Solutions and Innovations to Overcome Chronic Kidney Disease, Alberta Health services, First Nations Health Authority, First Nations Health and Social Secretariat of Manitoba, Research Manitoba, Shared Health Laboratory Services of Manitoba, Seven Oaks Hospital Chronic Disease Innovation Centre, Keewatinohk Inniniw Minoayawin Inc. (KIM)
- Responsible party
- Principal investigator, Dr. Paul Komenda, University of Manitoba
- Investigators
- Paul Komenda, MD MHA, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03595267
- Sponsor's protocol ID
- HS20110 (H2016:348)
- Status last verified
- Jun 2025
- First submitted
- 12 Jul 2018
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lavallee B, Chartrand C, McLeod L, Rigatto C, Tangri N, Dart A, Gordon A, Ophey S, Komenda P. Mass screening for chronic kidney disease in rural and remote Canadian first nations people: methodology and demographic characteristics. Can J Kidney Health Dis. 2015 Mar 19;2:9. doi: 10.1186/s40697-015-0046-9. eCollection 2015.
PubMed 27408755Komenda P, Lavallee B, Ferguson TW, Tangri N, Chartrand C, McLeod L, Gordon A, Dart A, Rigatto C. The Prevalence of CKD in Rural Canadian Indigenous Peoples: Results From the First Nations Community Based Screening to Improve Kidney Health and Prevent Dialysis (FINISHED) Screen, Triage, and Treat Program. Am J Kidney Dis. 2016 Oct;68(4):582-590. doi: 10.1053/j.ajkd.2016.04.014. Epub 2016 May 30.
PubMed 27257016Ferguson TW, Tangri N, Tan Z, James MT, Lavallee BDA, Chartrand CD, McLeod LL, Dart AB, Rigatto C, Komenda PVJ. Screening for chronic kidney disease in Canadian indigenous peoples is cost-effective. Kidney Int. 2017 Jul;92(1):192-200. doi: 10.1016/j.kint.2017.02.022. Epub 2017 Apr 20.
PubMed 28433383Harasemiw O, Milks S, Oakley L, Lavallee B, Chartrand C, McLeod L, Di Nella M, Rigatto C, Tangri N, Ferguson T, Komenda P. Remote Dwelling Location Is a Risk Factor for CKD Among Indigenous Canadians. Kidney Int Rep. 2018 Feb 10;3(4):825-832. doi: 10.1016/j.ekir.2018.02.002. eCollection 2018 Jul.
PubMed 29989009Komenda P, Ferguson TW, Macdonald K, Rigatto C, Koolage C, Sood MM, Tangri N. Cost-effectiveness of primary screening for CKD: a systematic review. Am J Kidney Dis. 2014 May;63(5):789-97. doi: 10.1053/j.ajkd.2013.12.012. Epub 2014 Feb 12.
PubMed 24529536Dart A, Lavallee B, Chartrand C, McLeod L, Ferguson TW, Tangri N, Gordon A, Blydt-Hansen T, Rigatto C, Komenda P. Screening for kidney disease in Indigenous Canadian children: The FINISHED screen, triage and treat program. Paediatr Child Health. 2018 Nov;23(7):e134-e142. doi: 10.1093/pch/pxy013. Epub 2018 Apr 14.
PubMed 30374222Curtis S, Martin H, DiNella M, Lavallee B, Chartrand C, McLeod L, Woods C, Dart A, Tangri N, Rigatto C, Komenda P. Kidney Check Point-of-Care Testing-Furthering Patient Engagement and Patient-Centered Care in Canada's Rural and Remote Indigenous Communities: Program Report. Can J Kidney Health Dis. 2021 Mar 31;8:20543581211003744. doi: 10.1177/20543581211003744. eCollection 2021.
PubMed 33868690Curtis S, Sokoro A, Martin H, McLeod L, Chartrand C, Lavallee B, Woods C, Di Nella M, Levin A, Komenda P. A Comprehensive Quality Assurance Platform in Canada for National Point-of-Care Chronic Kidney Disease Screening: The Kidney Check Program. Kidney Int Rep. 2020 Dec 30;6(2):513-517. doi: 10.1016/j.ekir.2020.11.031. eCollection 2021 Feb. No abstract available.
PubMed 33615077
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Approaches to Chronic Kidney Disease Case Finding in Indigenous Communities
- ClinicalTrials.gov ID
- NCT03595267
- Acronym / sponsor ID
- HS20110 (H2016:348)
- Conditions
- Chronic Kidney Disease, Diabetes, Hypertension
- Keywords
- Indigenous Canadians, Screening Study
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Canadians Seeking Solutions and Innovations to Overcome Chronic Kidney Disease, Alberta Health services, First Nations Health Authority, First Nations Health and Social Secretariat of Manitoba, Research Manitoba, Shared Health Laboratory Services of Manitoba, Seven Oaks Hospital Chronic Disease Innovation Centre, Keewatinohk Inniniw Minoayawin Inc. (KIM)
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 23 Jul 2018 (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.
Faced with limited access to preventative health care services, Indigenous people living in rural and remote communities are at a higher risk of Chronic Kidney Disease (CKD) and kidney failure, when compared to the general population. The goal of this project is to perform point-of-care testing for CKD and its risk factors, including diabetes and high blood pressure, for individuals residing in rural and remote Indigenous communities across the Canadian provinces of Manitoba, British Columbia, Alberta, Saskatchewan, and Ontario. In addition to providing individuals with information about their risk of developing CKD, as well as providing tailored treatment plans, this study will help provide evidence to develop a permanent CKD surveillance system in all Indigenous communities across Canada, consequently decreasing the burden of CKD and kidney failure in these communities.
Detailed description
Compared to the general population, Indigenous people disproportionately suffer from higher rates of diabetes, hypertension, obesity, and chronic kidney disease (CKD), when compared to their non-Indigenous counterparts. However, rates of these morbidities are greatest for Indigenous individuals living in rural and remote areas, where social inequalities such as poverty and poor access to services - in particular reduced access to primary care and nephrology specialists - are the most the salient.
If caught and treated early in its course, kidney failure is often preventable, especially for those at the highest risk of progression. However, CKD is often unrecognizable and asymptomatic until it is in its later stages, when the chances of preventing kidney failure are limited. Therefore, in order to administer targeted therapeutic interventions, early identification and stratification of those at highest risk of CKD are urgently needed. Screening programs using state of the art point-of-care testing equipment with blood and urine samples can test for CKD both quickly and accurately. While general population-based screening have not been found to be beneficial, targeted screening directed toward high-risk patients with diabetes and high blood pressure, or high-risk populations known to progress rapidly or have limited access to primary health care, are cost-effective. In particular, research has shown that the cost utility of one-off, point-of-care screening and treatment for CKD in rural and remote Indigenous communities is highly cost-effective when compared to usual care provided in these geographic areas.
The goal of this project is to develop a platform that will enable the early diagnosis of Indigenous adults and children with CKD living in Indigenous communities across Canada, and lead to treatment and follow up care targeted to each individual's risk of kidney failure. By developing mobile mass screening and prevention initiatives in adults and children for the prevention of CKD and kidney failure, appropriate treatment and follow-up will continue, and rates of CKD progression will decline, with fewer patients reaching kidney failure requiring dialysis. In addition, this project will further demonstrate the benefits of front line surveillance, risk prediction and treatment, and lead to novel insights regarding prognosis, and the factors driving kidney disease in Indigenous communities, ultimately serving as the gold-standard model for delivery of kidney care across Canada.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rural and Remote Indigenous Communities | – | Other: Point-of-care screeningPoint-of-care screening for Chronic Kidney Disease, Diabetes, and Hypertension will be administered in rural and remote communities in Manitoba, British Columbia, Alberta, Saskatchewan, and Ontario. |
Who may qualify
- Ages
- 10 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Indigenous communities in rural (accessible by road), and remote (accessible by flying-in, or winter ice roads) areas of Manitoba, British Columbia, Alberta, Saskatchewan and Ontario will be targeted for the screening program.
Key inclusion criteria (1 listed)
- All individuals aged 10 years old - 80 years old will be recruited for screening, regardless of known CKD risk factors, such as diabetes, elevated blood pressure, or family history of kidney disease.
Key exclusion criteria (1 listed)
- None.
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 |
|---|---|---|
| Point-of-care screeningAfter consent is obtained, a registered nurse will administer a demographic questionnaire, collecting the participant's personal health number, age, gender, date of birth, and name of community. Physical data including height, weight, and blood pressure will also be collected. A blood sample and a urine sample will be taken, with point-of-care testing being performed during the screening appointment to allow for results of the testing to be received and discussed with each patient at the time of the appointment. After screening, to ensure a "closed loop" system of care, patients at the highest risk of kidney failure will be referred to a nephrologist, while those at lower risk will be referred to their primary care provider with specific treatment and re-testing recommendations. | Other | Rural and Remote Indigenous Communities |
Primary outcome
Biomarkers of Kidney Function
Time frame: 1 day (At time of screening)
eGFR; Albuminuria; Urine ACR
Diabetes
Time frame: 1 day (At time of screening)
Defined as a Hemoglobin A1c => 6.5%
Elevated Blood Pressure
Time frame: 1 day (At time of screening)
Defined as a Systolic Blood Pressure > 140 mmHg, or Diastolic Blood Pressure > 90mmHg
Kidney Failure Risk
Time frame: 1 day (At time of screening)
Measured using the Kidney Failure Risk Equation
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 11 Jun 2025.
- Background: PubMed 27408755Lavallee B, Chartrand C, McLeod L, Rigatto C, Tangri N, Dart A, Gordon A, Ophey S, Komenda P. Mass screening for chronic kidney disease in rural and remote Canadian first nations people: methodology and demographic characteristics. Can J Kidney Health Dis. 2015 Mar 19;2:9. doi: 10.1186/s40697-015-0046-9. eCollection 2015.
- Background: PubMed 27257016Komenda P, Lavallee B, Ferguson TW, Tangri N, Chartrand C, McLeod L, Gordon A, Dart A, Rigatto C. The Prevalence of CKD in Rural Canadian Indigenous Peoples: Results From the First Nations Community Based Screening to Improve Kidney Health and Prevent Dialysis (FINISHED) Screen, Triage, and Treat Program. Am J Kidney Dis. 2016 Oct;68(4):582-590. doi: 10.1053/j.ajkd.2016.04.014. Epub 2016 May 30.
- Background: PubMed 28433383Ferguson TW, Tangri N, Tan Z, James MT, Lavallee BDA, Chartrand CD, McLeod LL, Dart AB, Rigatto C, Komenda PVJ. Screening for chronic kidney disease in Canadian indigenous peoples is cost-effective. Kidney Int. 2017 Jul;92(1):192-200. doi: 10.1016/j.kint.2017.02.022. Epub 2017 Apr 20.
- Background: PubMed 29989009Harasemiw O, Milks S, Oakley L, Lavallee B, Chartrand C, McLeod L, Di Nella M, Rigatto C, Tangri N, Ferguson T, Komenda P. Remote Dwelling Location Is a Risk Factor for CKD Among Indigenous Canadians. Kidney Int Rep. 2018 Feb 10;3(4):825-832. doi: 10.1016/j.ekir.2018.02.002. eCollection 2018 Jul.
- Background: PubMed 24529536Komenda P, Ferguson TW, Macdonald K, Rigatto C, Koolage C, Sood MM, Tangri N. Cost-effectiveness of primary screening for CKD: a systematic review. Am J Kidney Dis. 2014 May;63(5):789-97. doi: 10.1053/j.ajkd.2013.12.012. Epub 2014 Feb 12.
- Background: PubMed 30374222Dart A, Lavallee B, Chartrand C, McLeod L, Ferguson TW, Tangri N, Gordon A, Blydt-Hansen T, Rigatto C, Komenda P. Screening for kidney disease in Indigenous Canadian children: The FINISHED screen, triage and treat program. Paediatr Child Health. 2018 Nov;23(7):e134-e142. doi: 10.1093/pch/pxy013. Epub 2018 Apr 14.
- Background: PubMed 33868690Curtis S, Martin H, DiNella M, Lavallee B, Chartrand C, McLeod L, Woods C, Dart A, Tangri N, Rigatto C, Komenda P. Kidney Check Point-of-Care Testing-Furthering Patient Engagement and Patient-Centered Care in Canada's Rural and Remote Indigenous Communities: Program Report. Can J Kidney Health Dis. 2021 Mar 31;8:20543581211003744. doi: 10.1177/20543581211003744. eCollection 2021.
- Background: PubMed 33615077Curtis S, Sokoro A, Martin H, McLeod L, Chartrand C, Lavallee B, Woods C, Di Nella M, Levin A, Komenda P. A Comprehensive Quality Assurance Platform in Canada for National Point-of-Care Chronic Kidney Disease Screening: The Kidney Check Program. Kidney Int Rep. 2020 Dec 30;6(2):513-517. doi: 10.1016/j.ekir.2020.11.031. eCollection 2021 Feb. No abstract available.
- Study websiteLink provided by the sponsor.
- 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.
Paul Komenda, MD MHA principal investigator
University of Manitoba
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease and Diabetes, run by University of Manitoba at 3 sites 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Maria James, MSc (2049513040, mjames4@sogh.mb.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biomarkers of Kidney Function (time frame: 1 day (At time of screening)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03595267, which also lists 8 linked publications.
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 11 Jun 2025.