Recruiting

NAVIGATE-Kidney

Sponsor:

University of Colorado, Denver

Code:

NCT06810622

Conditions

Kidney Diseases

Chronic Kidney Diseases

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Community health worker intervention

Standard Care (in control arm)

Study Details

Brief summary:

The overarching goal of this project is to refine and adapt previous work on the NAVIGATE-Kidney project for individuals with CKD. The investigators hypothesize that the multilevel NAVIGATE-Kidney program intervention will reduce the rate of central venous catheter use at KRT start (primary outcome), increase the rate of optimal KRT starts (secondary outcome), increase patient activation, and reduce decisional conflict (patient-centered outcomes) for individuals with advanced CKD. The project will have four (4) aims.

Conditions

Kidney Diseases

Chronic Kidney Diseases

Study ID

NCT06810622

Start date

Mar 18, 2026

Status verified date

Jul, 2026

Completion date

May 15, 2029

Anticipated

Primary completion date

May 15, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

448 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Navigate-Kidney CHW Arm

Arm Description: A CHW will provide support during visits every 2 weeks for 3 months (i.e., 6 visits during first 3 months) followed by monthly visits until 1 year of study participation and then quarterly visits until 2 years of study participation. The CHW Navigate-Kidney intervention includes 4 functions: (1) Build trust through understanding of health experience; (2) Address multilevel social and challenges to facilitate health system navigation; (3) Provide patient-centered education; and (4) Enhance self-management. To provide patient-centered education, the CHW will use a Decision Aid created for this intervention.

active comparator: Standard Care

Arm Description: Arm Description: Participants will receive standard medical care following diagnosis. This care will include educational materials developed that describe prevention of CKD progression, KRT options, and conservative management in English or Spanish

Interventions

Community health worker intervention

Community health worker support that includes building trust, addressing social challenges, providing patient-centered education, and enhancing self-management.

Standard Care (in control arm)

Participants receive standard care

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Lilia Cervantes, MD

3036418009lilia.cervantes@cuanschutz.edu

Sandra Hernandez, MPH

SANDRA.GARCIA-HERNANDEZ@CUANSCHUTZ.EDU

Locations

Denver Health and Hospital Authority

Recruiting

Denver, Colorado, United States, 80204

Contacts

Seth Furgeson, MD

303-724-5063seth.furgeson@dhha.org

Rocio Pereira, MD

3034366000rocio.perieira@dhha.org

Principal Investigator:

Seth Furgeson, MD

More Information

Sponsor

University of Colorado, Denver

Last update posted

Jul 24, 2026

Last verified

Jul, 2026

Keywords

  • Kidney
  • Chronic
  • Dialysis
  • Transplant

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2026-07-24.