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Kidney Check: Diabetes, Blood Pressure & Kidney Health Checks & Care in Indigenous Communities.

Optimal Approaches to Chronic Kidney Disease Case Finding in Indigenous Communities

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03595267
Enrollment
2500
Registered
2018-07-23
Start date
2019-10-01
Completion date
2025-12-31
Last updated
2025-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease, Diabetes, Hypertension

Keywords

Indigenous Canadians, Screening Study

Brief 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. 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.

Interventions

OTHERPoint-of-care screening

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.

Sponsors

Canadians Seeking Solutions and Innovations to Overcome Chronic Kidney Disease
CollaboratorOTHER
Alberta Health services
CollaboratorOTHER
First Nations Health Authority
CollaboratorUNKNOWN
First Nations Health and Social Secretariat of Manitoba
CollaboratorUNKNOWN
Research Manitoba
CollaboratorOTHER
Shared Health Laboratory Services of Manitoba
CollaboratorUNKNOWN
Seven Oaks Hospital Chronic Disease Innovation Centre Inc.
CollaboratorUNKNOWN
Keewatinohk Inniniw Minoayawin Inc. (KIM)
CollaboratorUNKNOWN
University of Manitoba
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
10 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

* 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.

Exclusion criteria

* None.

Design outcomes

Primary

MeasureTime frameDescription
Biomarkers of Kidney Function1 day (At time of screening)eGFR; Albuminuria; Urine ACR
Diabetes1 day (At time of screening)Defined as a Hemoglobin A1c =\> 6.5%
Elevated Blood Pressure1 day (At time of screening)Defined as a Systolic Blood Pressure \> 140 mmHg, or Diastolic Blood Pressure \> 90mmHg
Kidney Failure Risk1 day (At time of screening)Measured using the Kidney Failure Risk Equation

Countries

Canada

Contacts

Primary ContactMaria James, MSc
mjames4@sogh.mb.ca2049513040

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026