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

NCT03595267 | Recruiting

• 1 other identifier: HS20110 (H2016:348)
• Study Type: observational
• Target: 2,500
• Locations: 1 country
• Sites: 3

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

Keywords

Indigenous Canadians; Screening Study

Outcome Measures

Primary Outcomes (4)

• Biomarkers of Kidney Function

  eGFR; Albuminuria; Urine ACR

  1 day (At time of screening)

• Diabetes

  Defined as a Hemoglobin A1c =\> 6.5%

  1 day (At time of screening)

• Elevated Blood Pressure

  Defined as a Systolic Blood Pressure \> 140 mmHg, or Diastolic Blood Pressure \> 90mmHg

  1 day (At time of screening)

• Kidney Failure Risk

  Measured using the Kidney Failure Risk Equation

  1 day (At time of screening)

Study Arms (1)

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.

Other: Point-of-care screening

Interventions

Point-of-care screening OTHER

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.

Rural and Remote Indigenous Communities

Eligibility Criteria

• Age: 10 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• None.

Sponsors & Collaborators

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

Study Sites (3)

Alberta Health Services

Calgary, Alberta, T2W1S7, Canada

RECRUITING

First Nations Research and Knowledge Exchange

West Vancouver, British Columbia, V7T 1A2, Canada

RECRUITING

Chronic Disease Innovation Centre

Winnipeg, Manitoba, R2V 3M3, Canada

ENROLLING BY INVITATION

Related Publications (8)

• 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.

  PMID: 27408755 BACKGROUND

• Komenda 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.

  PMID: 27257016 BACKGROUND

• Ferguson 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.

  PMID: 28433383 BACKGROUND

• Harasemiw 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.

  PMID: 29989009 BACKGROUND

• Komenda 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.

  PMID: 24529536 BACKGROUND

• Dart 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.

  PMID: 30374222 BACKGROUND

• Curtis 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.

  PMID: 33868690 BACKGROUND

• Curtis 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.

  PMID: 33615077 BACKGROUND

Related Links

• Study website

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Diabetes Mellitus; Hypertension

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Paul Komenda, MD MHA

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria James, MSc

CONTACT

2049513040; mjames4@sogh.mb.ca

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 12, 2018
• First Posted: July 23, 2018
• Study Start: October 1, 2019
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: June 11, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)