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NAVIGATE Kidney: Reducing Kidney Health Disparities

This study, called NAVIGATE Kidney, is testing a program to help people with advanced kidney disease (eGFR 15-29 mL/min/1.73m2). The program uses community health workers to provide support, education, and help with social challenges. Researchers want to see if this program can reduce the need for kidney replacement therapy (like dialysis) that uses a central venous catheter (a tube placed in a large vein) or death, compared to standard care. You might be able to join if you are an adult between 18 and 75 years old with advanced kidney disease, and have not had a kidney transplant or surgery for dialysis. The study aims to enroll 448 people, but its current status is unclear.

Study design
This is an interventional study comparing a community health worker program to standard care. It plans to enroll 448 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your health will be monitored from the start of the study until the end of the study, or until kidney replacement therapy begins, or death, whichever happens first (up to 5 years).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06810622

NAVIGATE Kidney: A Multi-level Intervention to Reduce Kidney Health Disparities

Recruiting
NAAges 18–75InterventionalSupportive care
University of Colorado, Denver
~448 participants
Updated 2026-07-24 on ClinicalTrials.gov
What's tested:Community health worker interventionStandard Care (in control arm)

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Composite Outcome: Time Until Kidney Replacement Therapy (KRT) Start with Central Venous Catheter (CVC) Use or Death
Measured over From Baseline until End of Study, KRT Start, or Death, whichever occurs first (up to 5 years)

Conditions

Kidney Diseases
Chronic Kidney Diseases

Explore related trials

Chronic Kidney Disease

NCT06810622

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Denver Health and Hospital Authority

    Denver, Coloradostudy coordinator listed

    Recruiting

  • University of New Mexico Health Science Center

    Albuquerque, New Mexicostudy coordinator listed

    Not yet recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Lilia Cervantes, MD · PRINCIPAL_INVESTIGATOR · University of Colorado-Anschutz SOM-Hospital Medicine

Who to contact

Lilia Cervantes, MD
[email protected]
3036418009
Email the study team

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Eligibility criteria

Inclusion

Adults ≥ 18 years of age,
Adults who are not pregnant,
Adults who are not incarcerated,
Adults who have advanced kidney disease with an eGFR of 15-29 mL/min/1.73m2). No other measures are used to identify eligible patients.

Exclusion

Previous kidney transplant
Previous surgery for dialysis such as an arteriovenous fistula, arteriovenous graft, or peritoneal dialysis catheter placement
On chronic dialysis
Conservative management or primary goal is palliation
Incarcerated
Pregnant\*
Under 18 years of age
Moderate to severe dementia
Deaf persons
Lacking health insurance\*\*
Investigator Discretion: Individuals who, in the judgment of the Site PI (or designee), are deemed unsuitable for participation due to behavioral or logistical circumstances that could compromise study integrity or the safety of the participant or staff.

What this trial measures

  • Composite Outcome: Time Until Kidney Replacement Therapy (KRT) Start with Central Venous Catheter (CVC) Use or DeathFrom Baseline until End of Study, KRT Start, or Death, whichever occurs first (up to 5 years)

    Composite outcome of time until participants in each arm either 1) begin dialysis (either as first KRT method or as a subsequent preparatory step for transplant) with a central venous catheter (CVC)), or 2) die from all-cause mortality, whichever occurs first.