Improving Access to Renal Transplantation for Underserved Black Communities

Phase 2

Not yet recruiting

• Conditions: Kidney Transplant; ESRD (End Stage Renal Disease)

• Registration Number: NCT06707038
• Lead Sponsor: Northwestern University

Brief Summary

The goal of this clinical trial is to learn whether the African American Transplant Access Program can be successfully replicated at another large kidney transplant program. The main questions it aims to answer are:
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Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-21
• Study First Submitted QC: 2024-11-26
• Last Update Submitted: 2024-11-26
• Study First Posted: 2024-11-27
• Last Update Posted: 2024-11-27
• Study Start: 2025-01-01
• Primary Completion: 2028-06-30
• Study Completion: 2029-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 356

Inclusion Criteria

• self-identify as Black or African American;
• 18 to 75 years of age
• have an eGFR < 20 or End Stage Renal Disease Diagnosis;
• screen positive for AATAP via the screener (for poor health literacy or poor medical adherence or psychosocial concerns);
• medically eligible to begin transplant evaluation process determined by transplant team

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Exclusion Criteria

• other racial groups
• participants who have previously received a transplant;
• pregnant women;
• participants who screen negative on the screener;
• children less than 18 years old

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Listing status for each Arm by month 12	12 months from time of enrollment	Listing (active or inactive) status by month 12

Secondary Outcome Measures

Name	Time	Method
Quality of life using PROMIS 1.2 Global Health Scale	at enrollment and at 12 months after enrollment	T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population
self-efficacy in kidney dialysis management using Perceived Kidney/Dialysis Self-Management Scale (PKDSMS)	at enrollment and at 12 months after enrollment	average score on a five point scale
trust in care received by transplant team using Adapted Trust in Physicians Scale	at enrollment and at 12 months after enrollment	sum of scores on five point scale (1=Strongly Disagree to 5= Strongly Agree)

Trial Locations

Locations (1)

Tampa General Hospital; 🇺🇸 Tampa, Florida, United States