TxAccess and Dd-cfDNA for Improved Care of Patients With Delayed Graft Function

September 12, 2026 updated by: Duke University
This is a prospective multicenter nonrandomized pragmatic hybrid effectiveness-implementation study to test the effectiveness of TxAccess in improving time to renal recovery and immunologic outcomes in patients with delayed graft function (DGF) and to assess barriers and facilitators to implementation of TxAccess in the post-transplant care period. Research blood will be collected for donor-derived cell-free DNA testing, and patient questionnaires will be administered.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

450

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Study Population: Patients Inclusion criteria: Adult patients who experienced delayed graft function after a deceased donor kidney transplant in the last 2 calendar years

Exclusion criteria: Patients younger than 18 years old at the time of transplant; patients who experienced graft loss prior to discharge from their index hospitalization patients who receive outpatient dialysis at a center that does not utilize TxAccess (intervention period)

Study Population: Clinicians Inclusion criteria: adult clinicians who participate in care of kidney transplant recipients, including surgeons, nephrologists, pharmacists, social workers, nurse coordinators, advanced practice providers, nurses, case managers and dialysis center clinicians and staff.

Exclusion criteria: clinicians and staff who are not employed at participating centers or do not have direct patient contact or experience with care coordination

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TxAccess Intervention Arm
Participants receive standard post-transplant care with deployment of the TxAccess platform and dd-cfDNA monitoring.
Device: TxAccess
Software platform facilitating communication between transplant centers, nephrology practices, and dialysis facilities.
Diagnostic test: Donor-Derived Cell-Free DNA (dd-cfDNA)
Blood testing to assess allograft injury and immunologic outcomes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Delayed Graft Function (DGF) severity, defined as time to freedom from dialysis
Time Frame: through 90 days post-transplant
through 90 days post-transplant

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Allograft biopsy rate
Time Frame: first post transplant year
Number of allograft biopsies
first post transplant year
Health Care Resource Utilization (hospital length of stay)
Time Frame: first post transplant year
Hospital length of stay
first post transplant year
Health Care Resource Utilization (readmission rate)
Time Frame: first post transplant year
Hospital readmission rate
first post transplant year
Health Care Resource Utilization (days in intensive care unit)
Time Frame: first post transplant year
Days in the intensive care unit
first post transplant year
Dialysis utilization
Time Frame: 90 days after transplant procedure
number of dialysis sessions
90 days after transplant procedure
Health care related quality of life
Time Frame: 90 days after transplant procedure
Change in PROMIS measures
90 days after transplant procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

CareDx, Inc.

Investigators

  • Principal Investigator: Lisa McElroy, Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 15, 2026

Primary Completion (Estimated)

January 31, 2029

Study Completion (Estimated)

June 30, 2029

Study Registration Dates

First Submitted

September 8, 2026

First Submitted That Met QC Criteria

September 12, 2026

First Posted (Actual)

September 17, 2026

Study Record Updates

Last Update Posted (Actual)

September 17, 2026

Last Update Submitted That Met QC Criteria

September 12, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO00118551

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe