Clinical trial NCT03595267: Kidney Check: Diabetes, Blood Pressure & Kidney Health Checks & Care in Indigenous Communities.
Official title: Optimal Approaches to Chronic Kidney Disease Case Finding in Indigenous Communities
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Kidney Disease
Diabetes
Hypertension
Keywords: Indigenous Canadians
Screening Study
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: Canadians Seeking Solutions and Innovations to Overcome Chronic Kidney Disease
name: Alberta Health services
name: First Nations Health Authority
name: First Nations Health and Social Secretariat of Manitoba
name: Research Manitoba
name: Shared Health Laboratory Services of Manitoba
name: Seven Oaks Hospital Chronic Disease Innovation Centre Inc.
name: Keewatinohk Inniniw Minoayawin Inc. (KIM)
First posted: 2018-07-23
Enrollment: 2500
Sex: ALL
Minimum age (years): 10
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Biomarkers of Kidney Function
timeFrame: 1 day (At time of screening)
measure: Diabetes
timeFrame: 1 day (At time of screening)
measure: Elevated Blood Pressure
timeFrame: 1 day (At time of screening)
measure: Kidney Failure Risk
timeFrame: 1 day (At time of screening)
Secondary outcomes:
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Alberta Health Services
state: Alberta
city: West Vancouver
country: Canada
facility: First Nations Research and Knowledge Exchange
state: British Columbia
city: Winnipeg
country: Canada
facility: Chronic Disease Innovation Centre
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Paul Komenda, MD MHA
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.