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Delayed Graft FunctionNCT07825688

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

A study testing TxAccess and Donor-Derived Cell-Free DNA (dd-cfDNA) in people with Delayed Graft Function, run by Duke University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Delayed Graft Function
What is being tested?
TxAccess and Donor-Derived Cell-Free DNA (dd-cfDNA)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
450 participants
Where
No sites listed yet
Study dates
15 Sep 2026to 30 Jun 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

About this study

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.

Being tested
TxAccess, Donor-Derived Cell-Free DNA (dd-cfDNA)
Keywords
Kidney Transplant, Delayed Graft Function, Donor-Derived Cell-Free DNA
Medical subject headings
Delayed Graft Function

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TxAccessDevice

    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.

Study groups in NCT07825688
Study groupRoleWhat they receive
TxAccess Intervention ArmExperimentalParticipants receive standard post-transplant care with deployment of the TxAccess platform and dd-cfDNA monitoring.
Receives: Device: TxAccess; Diagnostic Test: Donor-Derived Cell-Free DNA (dd-cfDNA)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: through 90 days post-transplant

Secondary outcomes (6)

  1. Allograft biopsy rate

    Number of allograft biopsies

    Measured: first post transplant year

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

    Hospital length of stay

    Measured: first post transplant year

  3. Health Care Resource Utilization (readmission rate)

    Hospital readmission rate

    Measured: first post transplant year

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

    Days in the intensive care unit

    Measured: first post transplant year

  5. Dialysis utilization

    number of dialysis sessions

    Measured: 90 days after transplant procedure

  6. Health care related quality of life

    Change in PROMIS measures

    Measured: 90 days after transplant procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Sep 2026
  2. Study start15 Sep 2026 (estimated)
  3. Primary completion31 Jan 2029 (estimated)
  4. Study completion30 Jun 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
450 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07825688
Sponsor's protocol ID
PRO00118551
Status last verified
May 2026
First submitted
8 Sep 2026
Last updated
17 Sep 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing TxAccess and Donor-Derived Cell-Free DNA (dd-cfDNA) in people with Delayed Graft Function, run by Duke University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Delayed Graft Function (DGF) severity, defined as time to freedom from dialysis (time frame: through 90 days post-transplant). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07825688.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.

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