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NCT Number: NCT07825688

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

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.

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Key information

Conditions

Delayed Graft Function Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TxAccess

Device

Software platform facilitating communication between transplant centers, nephrology practices, and dialysis facilities.

donor-derived cell-free DNA (dd-cfDNA)

Diagnostic Test

Blood testing to assess allograft injury and immunologic outcomes.

Primary outcomes

  1. Delayed Graft Function (DGF) severity, defined as time to freedom from dialysis

    Time frame: through 90 days post-transplant

Secondary outcomes

  1. Allograft biopsy rate

    Time frame: first post transplant year

    Number of allograft biopsies

  2. Health Care Resource Utilization (hospital length of stay)

    Time frame: first post transplant year

    Hospital length of stay

  3. Health Care Resource Utilization (readmission rate)

    Time frame: first post transplant year

    Hospital readmission rate

  4. Health Care Resource Utilization (days in intensive care unit)

    Time frame: first post transplant year

    Days in the intensive care unit

  5. Dialysis utilization

    Time frame: 90 days after transplant procedure

    number of dialysis sessions

  6. Health care related quality of life

    Time frame: 90 days after transplant procedure

    Change in PROMIS measures

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • CareDx, Inc.

Registry information

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Sep 17, 2026
Registry last updated
Sep 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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