NCT06223750

Brief Summary

The goal of this clinical trial is to determine the most effective way to complete population-based screening for chronic kidney disease (CKD) in First Nations adults in Manitoba. The main questions it aims to answer are:

  • To identify chronic kidney disease in First Nations adults in Manitoba
  • To risk stratify patients as low, moderate and high risk of kidney failure and organize active surveillance by risk category
  • To initiate treatments to prevent to progression of chronic kidney disease in individuals at risk of kidney failure Participants will be randomized to:
  • Patient contact via mail with a letter and laboratory requisition for serum creatinine and urine Albumin Creatinine Ratio
  • Patient and primary care network contact via mail with a letter but no laboratory requisition

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,356

participants targeted

Target at P75+ for not_applicable

Timeline
36mo left

Started Nov 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress34%
Nov 2024Apr 2029

First Submitted

Initial submission to the registry

December 19, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 25, 2024

Completed
9 months until next milestone

Study Start

First participant enrolled

November 1, 2024

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2029

Last Updated

September 2, 2025

Status Verified

August 1, 2025

Enrollment Period

4.4 years

First QC Date

December 19, 2023

Last Update Submit

August 25, 2025

Conditions

Kidney Disease, Chronic

Outcome Measures

Primary Outcomes (1)

  • The proportion of individuals who undergo screening for Chronic Kidney Disease (CKD)

    The proportion of individuals screened for Chronic Kidney Disease using one screening strategy is compared to the proportion of individuals screened using the other screening strategy.

    6 months

Secondary Outcomes (16)

  • New diagnosis of CKD (Chronic Kidney Disease)

    5 years

  • Anti-hyperintensive therapy

    5 years

  • Renin angiotensin aldosterone inhibitor blockade treatment

    5 years

  • Sodium Glucose Cotransporter 2 (SGLT2) inhibition treatment

    5 years

  • Mineral corticoid receptor antagonist treatment

    5 years

  • +11 more secondary outcomes

Study Arms (2)

Patient contact via mail with a letter and laboratory requisition

OTHER

Patient contact via mail with a letter and laboratory requisition for serum creatinine and urine albumin to creatinine ratio

Other: population-based screening for chronic kidney disease

Patient and primary care network contact via mail with a letter but no laboratory requisition

OTHER
Other: population-based screening for chronic kidney disease

Interventions

population-based screening for chronic kidney diseaseOTHER

Randomized controlled trial that uses an integrated health platform for eligibility and outcome assessments

Patient and primary care network contact via mail with a letter but no laboratory requisitionPatient contact via mail with a letter and laboratory requisition

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age\>= 18 years
  • Resident of Manitoba
  • First Nations
  • Urban, rural or remote location

You may not qualify if:

  • Kidney failure (dialysis or transplant)
  • chronic kidney disease (estimated Glomerular Filtration Rate \<60 milliliter/1.73square meter for 3 months)
  • Screening for chronic kidney disease with estimated Glomerular Filtration Rate or Albumin to Creatinine ratio in the last 2 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chronic Disease Innovation Centre

Winnipeg, Canada

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • David Collister, MD, PhD, FRCPC

    University of Manitoba

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2023

First Posted

January 25, 2024

Study Start

November 1, 2024

Primary Completion (Estimated)

April 1, 2029

Study Completion (Estimated)

April 1, 2029

Last Updated

September 2, 2025

Record last verified: 2025-08

Locations

CA(1)