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Not yet recruitingNCT07825688ClinicalTrials.gov record

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

Delayed Graft Function

THE QUICK READ

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type
Interventional
Phase
Not applicable
Age range
18 years - Not specified
Sex eligible
All sexes
Healthy volunteers
Not accepted
Participants
450 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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

Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment
Not applicable
Masking
No masking
TxAccess Intervention Arm

Participants receive standard post-transplant care with deployment of the TxAccess platform and dd-cfDNA monitoring.

Device: TxAccess · Diagnostic Test: Donor-Derived Cell-Free DNA (dd-cfDNA)

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.

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

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

Time frame: through 90 days post-transplant

Not reported in this registry record.

Secondary measures

Allograft biopsy rate

Time frame: first post transplant year

Number of allograft biopsies

Health Care Resource Utilization (hospital length of stay)

Time frame: first post transplant year

Hospital length of stay

Health Care Resource Utilization (readmission rate)

Time frame: first post transplant year

Hospital readmission rate

Health Care Resource Utilization (days in intensive care unit)

Time frame: first post transplant year

Days in the intensive care unit

Dialysis utilization

Time frame: 90 days after transplant procedure

number of dialysis sessions

Health care related quality of life

Time frame: 90 days after transplant procedure

Change in PROMIS measures

No results are flagged as posted.

Review the complete result tables and limitations in the official record.

Open official results ↗

Research locations (0)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

No locations are listed. Use the official study contact.

Study team and timeline

Lead sponsor
Duke University
Study start
Nov 15, 2026 Estimated
Primary completion
Jan 31, 2029 Estimated
Study completion
Jun 30, 2029 Estimated
First posted
Sep 17, 2026 Actual
Last updated
Nov 10, 2026 Actual

Official study contacts

No central contact is listed. Check the locations and the official record.

Official study title

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

A HUMAN NEXT STEP

Ask Wellness Clinical Research

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Please do not include medical records, diagnoses, medications, insurance numbers or other sensitive details. This form is for general questions, not urgent care.

Sending a question does not enroll you in a trial.

Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.

Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026