TxAccess and Dd-cfDNA for Improved Care of Patients With Delayed Graft Function
Delayed Graft Function
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 screeningTreatment, 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.
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
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
Ask Wellness Clinical Research
Your message goes to WCR, including when this study is run by another organization. WCR may offer general guidance but may not operate this trial, have access to its team or be able to enroll you.
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
