Recruiting

Observational Study

Sponsor:

University of Manitoba

Code:

NCT03595267

Conditions

Chronic Kidney Disease

Diabetes

Hypertension

Eligibility Criteria

Sex: All

Age: 10 - 70+

Healthy Volunteers: Accepted

Interventions

Point-of-care screening

Study Details

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.

Conditions

Chronic Kidney Disease

Diabetes

Hypertension

Study ID

NCT03595267

Start date

Oct 1, 2019

Status verified date

Jun, 2025

Completion date

Dec, 2025

Anticipated

Primary completion date

Sep, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 10 - 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

2500 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Point-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.

Primary outcome measure

  • Biomarkers of Kidney Function [ Time Frame: 1 day (At time of screening) ]
  • Diabetes [ Time Frame: 1 day (At time of screening) ]
  • Elevated Blood Pressure [ Time Frame: 1 day (At time of screening) ]
  • Kidney Failure Risk [ Time Frame: 1 day (At time of screening) ]

Central Contacts and Locations

Central contacts

Maria James, MSc

2049513040mjames4@sogh.mb.ca

Locations

Alberta Health Services

Recruiting

Calgary, Alberta, Canada, T2W1S7

Contacts

Deenaz Zaidi, BSc

deenaz@ualberta.ca

First Nations Research and Knowledge Exchange

Recruiting

West Vancouver, British Columbia, Canada, V7T 1A2

Contacts

Catherine Turner

catherine.turner@fnha.ca

More Information

Sponsor

University of Manitoba

Last update posted

Jun 11, 2025

Last verified

Jun, 2025

Keywords

  • Indigenous Canadians
  • Screening Study

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Manitoba on 2025-06-11.