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Clinical Trials/NCT06707038
NCT06707038
Withdrawn
Not Applicable

Improving Access to Renal Transplantation for Underserved Black Communities

Northwestern University1 site in 1 country356 target enrollmentApril 1, 2025

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Kidney Transplant
Sponsor
Northwestern University
Enrollment
356
Locations
1
Primary Endpoint
Listing status for each Arm by month 12
Status
Withdrawn
Last Updated
11 months ago

Overview

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:

Does the AATAP intervention increase the number of Black patients who are listed for kidney transplant? Does the AATAP intervention have an effect on Black patient self-efficacy and trust in care team?

Researchers will compare kidney transplant listing status after 12 months of patients in the AATAP intervention to usual care patients to see if the AATAP program increases the number of patients listed for transplant.

Registry
clinicaltrials.gov
Start Date
April 1, 2025
End Date
May 6, 2025
Last Updated
11 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Daniela Ladner

Director, Northwestern University Transplant Outcomes Collaborative

Northwestern University

Eligibility Criteria

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

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

Outcomes

Primary Outcomes

Listing status for each Arm by month 12

Time Frame: 12 months from time of enrollment

Listing (active or inactive) status by month 12

Secondary Outcomes

  • Quality of life using Patient-Reported Outcomes Measurement Information System (PROMIS) 1.2 Global Health Scale(at enrollment and at 12 months after enrollment)
  • Self-Efficacy in Kidney Dialysis Management using Perceived Kidney/Dialysis Self-Management Scale (PKDSMS)(at enrollment and at 12 months after enrollment)
  • trust in care received by transplant team using Adapted Trust in Physicians Scale(at enrollment and at 12 months after enrollment)

Study Sites (1)

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