Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

Designing and Implementing a Safety Net Surveillance Program for High Risk CKD (CKD Safety-Net)

12 augustus 2026 bijgewerkt door: Navdeep Tangri, University of Manitoba

Designing and Implementing a Safety Net Surveillance Program for High Risk CKD (CKD Safety Net)

The objective of this initiative is to develop and evaluate a risk-based, provincial public health screening program for chronic kidney disease (CKD) that provides proactive care for adults at high-risk of kidney failure who have not previously been referred to a nephrologist, through risk stratification, triage, education, and follow-up.

Overall, we aim to demonstrate that an integrated risk-based provincial public health screening program for CKD is feasible, and improves identification of high-risk individuals, subsequently creating a model of care that can be adopted by other jurisdictions.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

A Parallel Group Randomized Controlled Trial will be conducted implementing our previously developed laboratory-based risk prediction models into a new provincial CKD surveillance system. Using administrative data through the Manitoba Centre for Health Policy (MCHP), we will identify all high-risk adults with CKD in Manitoba who had appropriate laboratory testing for CKD (i.e. at least 2 eGFR tests) completed in the 2 most recent years of available data, and who subsequently met nephrology referral criteria, but were never referred to a nephrologist. All individuals identified will be randomized to either: (1) receive a letter describing their results and an invitation for a consult with a clinical assistant and a nephrologist at Seven Oaks General Hospital, or (2) usual care (i.e. no letter and referral to nephrology based on their primary care physician/circle of care).

The program will support the integration of risk-based care at a population-level, in turn providing opportunities that will prompt changes in further investigation, treatment, referral for education, and inform a personalized medicine approach for patient-provider discussions regarding prognosis.

All outcomes will be collected using provincial administrative databases accessed through the Manitoba Centre for Health Policy (MCHP).

Studietype

Ingrijpend

Inschrijving (Geschat)

972

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3T 2N2
        • University of Manitoba
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Inclusion Criteria:

  • Age > 18 years old
  • Resident of Manitoba / has Manitoba Health coverage
  • Either:
  • 2 eGFR <15 mL/min/1.73m2 tests within a 2-year timeframe or
  • A greater than 10% 2-year kidney failure risk (at 2 separate timepoints within a 2-year timeframe) - using the 4-variable or 3-variable 2-year Kidney Failure Risk Equation (KFRE)

Exclusion Criteria:

  • A previous billing claim from a nephrologist
  • Receiving palliative care within 3 months of randomization
  • Previous history of dialysis and/or kidney transplantation

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Screening
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Intervention Arm
Individuals randomized to the intervention group will receive a letter from MCHP. A follow-up reminder letter will be sent at 3 months in individuals that do not respond to the initial invitation. Individuals who respond to the letter by contacting the study team will be scheduled for an initial clinic appointment with a Clinical Assistant/Nephrologist, and will begin receiving routine clinical care thereafter, as per local clinical guidelines.
Ander: Letter to participants

Individuals randomized to the intervention group will received a direct mailing consisting of:

  1. A letter explaining the purpose of the study and the benefits of screening for CKD, with contact information for the study team at Seven Oaks General Hospital / Chronic Disease Innovation Centre, who they may contact to receive further information and to book a follow-up appointment with a Clinical Assistant/Nephrologist
  2. A brief fact sheet on CKD A follow-up reminder letter will be sent at 3 months in individuals that do not respond to the initial invitation.
Geen tussenkomst: Control Arm
Individuals randomized to the control group will continue receiving usual care without any intervention from the study team. Their outcomes will be ascertained using de-identified administrative data. If the trial is successful, indivdiuals in the control group will be contacted for follow-up with a nephrologist in the same manner (i.e. through a mailout letter) as the intervention group was.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Composite of kidney failure and all-cause mortality
Tijdsspanne: within 12 months of letter mailout
Kidney failure defined as dialysis, kidney transplantation. Collected using provincial administrative databases accessed through the MCHP
within 12 months of letter mailout

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Attendance at a clinic visit with a nephrologist
Tijdsspanne: within 12 months of letter mailout
Collected using provincial administrative databases accessed through the MCHP
within 12 months of letter mailout
Individual components of the composite primary outcome
Tijdsspanne: within 12 months of letter mailout

Kidney failure (dialysis and/or transplantation) and all-cause mortality. Collected using provincial administrative databases accessed through the MCHP

o All-cause mortality
within 12 months of letter mailout
Alll-cause hospitalizations and emergency room visits
Tijdsspanne: within 12 months of letter mailout
Collected using provincial administrative databases accessed through the MCHP
within 12 months of letter mailout
Major adverse cardiac events
Tijdsspanne: within 12 months of letter mailout
Major adverse cardiac events (MACE+, defined as myocardial infarction (MI), ischemic stroke, incident heart failure (a new heart failure diagnosis in a patient without evidence of heart failure at baseline), heart failure admission (an inpatient admission with a concurrent diagnosis of heart failure in patients with a history of heart failure), or cardiovascular death (death within the same or next calendar month as discharge from an inpatient hospital stay involving a diagnosis code for heart failure, stroke, or MI)). Collected using provincial administrative databases accessed through the MCHP
within 12 months of letter mailout
The proportion of individuals starting a new prescription of RAAS inhibitors, SGLT2i, Ns-MRAs, Statins, and GLP-1 agonists
Tijdsspanne: within 12 months of letter mailout
Collected using provincial administrative databases accessed through the MCHP
within 12 months of letter mailout
eGFR (mL/min/1.73 m²)
Tijdsspanne: within 12 months of letter mailout
Collected using provincial administrative databases accessed through the MCHP
within 12 months of letter mailout
Urine albumin-to-creatinine ratio (mg/mmol)
Tijdsspanne: within 12 months of letter mailout
Collected using provincial administrative databases accessed through the MCHP
within 12 months of letter mailout
2-year Kidney Failure Risk Equation Score
Tijdsspanne: within 12 months of letter mailout
Collected using provincial administrative databases accessed through the MCHP
within 12 months of letter mailout

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Manitoba

Medewerkers

Seven Oaks Hospital Chronic Disease Innovation Centre
Can-SOLVE CKD Network

Onderzoekers

  • Hoofdonderzoeker: Navdeep Tangri, MD, PhD, University of Manitoba

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 augustus 2026

Primaire voltooiing (Geschat)

1 juni 2027

Studie voltooiing (Geschat)

1 maart 2028

Studieregistratiedata

Eerst ingediend

20 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

20 juli 2026

Eerst geplaatst (Werkelijk)

24 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

17 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

12 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • HS25871 (H2023:052)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren