NAVIGATE Kidney program to reduce gaps in care for people with advanced CKD

Navigate Kidney: A Multi-level Intervention to Reduce Kidney Health Disparities Among Individuals With Kidney Disease

This project will test whether a community health worker–led NAVIGATE-Kidney program helps adults with advanced CKD (eGFR 15–29) start kidney replacement treatment more safely and avoid early catheter use or premature death.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 448 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: University of Colorado, Denver (Academic / other)
• Locations: 2 sites (Denver, Colorado and 1 other locations)
• Trial ID: NCT06810622 on ClinicalTrials.gov

What this trial studies

The NAVIGATE-Kidney project compares a multilevel intervention led by community health workers to standard care for adults with advanced CKD stage 4/5 (eGFR 15–29 mL/min/1.73 m2). The primary composite outcome is time to transition to kidney replacement therapy with central venous catheter use or death, with secondary clinical outcomes including rates of optimal KRT starts and process measures. Patient-centered measures include patient activation, decisional conflict, and social challenges, and the team will also assess implementation using the PRISM framework and perform an economic evaluation. The trial is being conducted at sites affiliated with the University of Colorado and the University of New Mexico and builds on prior NAVIGATE work in maintenance hemodialysis populations.

Who should consider this trial

Good fit: Adults aged 18 or older with advanced kidney disease (eGFR 15–29 mL/min/1.73 m2) who are not pregnant, not incarcerated, without prior kidney transplant or prior dialysis access surgery, and who are willing and able to participate at the study sites are ideal candidates.

Not a fit: People already on chronic dialysis, those with prior kidney transplant or prior dialysis access surgery, those choosing conservative or palliative care, and individuals who are pregnant, incarcerated, have moderate to severe dementia, are deaf, or lack health insurance are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, NAVIGATE-Kidney could reduce early catheter use and improve the safety and planning of dialysis starts while improving patient activation and decision-making.

How similar studies have performed: Community health worker approaches and the team’s prior NAVIGATE work in maintenance hemodialysis have shown promise, but applying this multilevel model to people with stage 4 CKD is a novel extension.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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.

Where this trial is running

Denver, Colorado and 1 other locations

• Denver Health and Hospital Authority — Denver, Colorado, United States (Recruiting)
• University of New Mexico Health Science Center — Albuquerque, New Mexico, United States (Not_yet_recruiting)

Study contacts

• Principal investigator: Lilia Cervantes, MD — University of Colorado-Anschutz SOM-Hospital Medicine
• Study coordinator: Lilia Cervantes, MD

Conditions Kidney Diseases; Chronic Kidney Diseases; Kidney; Chronic; Dialysis; Transplant