Access to Kidney Transplantation in Minority Populations

NCT04615819 | Active Not Recruiting DMC

• 1 other identifier: 20-387 AKT-MP
• Study Type: interventional
• Target: 376
• Locations: 1 country
• Sites: 1

Brief Summary

Hispanic/Latino (HL) and American Indian (AI) patients are more likely than whites to have kidney failure, but less likely to complete transplant evaluation or receive a kidney transplant (KT), the best treatment for kidney failure. Using comparative effectiveness research methods, we will conduct a pragmatic randomized trial to compare the efficacy and cost- effectiveness of two approaches to help HL and AI patients overcome barriers to completing transplant evaluation and receiving a KT: a streamlined KT evaluation process and a peer-assisted evaluation program; and, we will determine best practices to assist other transplant centers in implementing the better program. Findings from this work may help reduce disparities in transplant evaluation and KT.

Conditions

Kidney Diseases

Keywords

Transplant

Outcome Measures

Primary Outcomes (1)

• Rate of KT evaluation completion

  Completion of evaluation for KT and placement on the transplant waiting list.

  Through study completion, an average of 1 year

Secondary Outcomes (2)

• KT ambivalence

  Through study completion, an average of 1 year

• Patient Reported Quality of Life

  Through study completion, an average of 1 year

Study Arms (2)

Arm 1

EXPERIMENTAL

KTFT

Other: Kidney Transplant Fast Track (KTFT)

Arm 2

EXPERIMENTAL

PN

Other: Peer Navigation (PN)

Interventions

Kidney Transplant Fast Track (KTFT) OTHER

Streamlined KT evaluation involving completion of most or all testing on the same day a patient arrives for their first pre-transplant clinic appointment. Or, a transplant clinic scheduler secures testing within a 4 week period.

Arm 1

Peer Navigation (PN) OTHER

Uses trained, previous KT recipients who meet weekly to monthly with patient participants to provide tailored information and assistance in completing the necessary steps to proceed to transplant.

Arm 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Undergoing kidney transplant evaluation at the University of New Mexico
• Greater than or equal to 18 years of age
• Mentally competent

You may not qualify if:

• Children less than 18 years of age are excluded because all research-related measurements are designed for patients over the age of 18. Children less than 18 years of age have dissimilar decision-making authority as a result of their developmental stage and dependency on adult guardians who must make all their transplant-related decisions, as required by all pediatric transplant centers. The proposed study focuses only on adult transplant patients.
• Waitlisted at another transplant center
• Prior kidney transplant
• Incarcerated patients
• Pregnant women
• Active systemic infection
• Non-skin malignancy or melanoma in the past 2 years
• Known cognitive impairment

Sponsors & Collaborators

• Case Western Reserve University: collaborator
• University of Massachusetts, Amherst: collaborator
• University of Pittsburgh: collaborator
• University of New Mexico: lead

Study Sites (1)

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

MeSH Terms

Conditions

Kidney Diseases

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Larissa Myaskovsky, PhD

  University of New Mexico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 7, 2020
• First Posted: November 4, 2020
• Study Start: January 11, 2022
• Primary Completion: March 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)