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Not yet recruitingNCT07825688Updated Nov 10, 2026

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

An interventional study of TxAccess and Donor-Derived Cell-Free DNA (dd-cfDNA) in Delayed Graft Function, sponsored by Duke University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-10.

Sponsored by Duke University · Not applicable, Interventional, and Health services research

Updated Nov 10, 2026Start date movedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
450
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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 the post-transplant care period. Research blood will be collected for donor-derived cell-free DNA testing, and patient questionnaires will be administered.

02

Conditions studied

  • Delayed Graft Function

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Keywords

  • Kidney Transplant
  • Delayed Graft Function
  • Donor-Derived Cell-Free DNA
03

In context

Delayed Graft Function

83 studies on the registry are indexed under Delayed Graft Function; 15 are open to participants now.

This study's planned enrollment of 450 is above the median of 90 across 62 interventional studies indexed under Delayed Graft Function.

Browse Delayed Graft Function studies →

Lead sponsor

Duke University is the lead sponsor of 2,063 studies on the registry; 273 are open to participants now.

Of its 204 completed or terminated interventional studies of FDA-regulated products, 167 (82%) have results posted.

Browse Duke University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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

05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
450 participants (estimated)

Study arms

  • Experimental
    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)

Interventions

  • DeviceTxAccess

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

  • Diagnostic testDonor-Derived Cell-Free DNA (dd-cfDNA)

    Blood testing to assess allograft injury and immunologic outcomes.

06

What researchers measure

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

    Number of allograft biopsies

    Time frame: first post transplant year

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

    Hospital length of stay

    Time frame: first post transplant year

  3. Health Care Resource Utilization (readmission rate)

    Hospital readmission rate

    Time frame: first post transplant year

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

    Days in the intensive care unit

    Time frame: first post transplant year

  5. Dialysis utilization

    number of dialysis sessions

    Time frame: 90 days after transplant procedure

  6. Health care related quality of life

    Change in PROMIS measures

    Time frame: 90 days after transplant procedure

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it moved

Start is estimated for Nov 2026; primary completion for Jan 2029, 26 months later.

Start moved once since we started tracking on Sep 25, 2026: Sep 2026 → Nov 2026, on Nov 10, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Sep 8, 2026
First posted
Sep 17, 2026
StartEst.
Nov 15, 2026was Sep 2026
Primary completionEst.
Jan 31, 2029
CompletionEst.
Jun 30, 2029
Last update
Nov 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Start date
Sep 15, 2026→Nov 15, 2026
Nov 10, 2026
Show all 1 update
  1. Nov 10, 2026
    Start date Sep 15, 2026→Nov 15, 2026
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07825688
Lead sponsor
Duke University
Collaborators
CareDx, Inc.
Responsible party
Sponsor
First posted
Sep 17, 2026
Start date
Nov 15, 2026 (estimated)
Primary completion
Jan 31, 2029 (estimated)
Completion
Jun 30, 2029 (estimated)
Last update
Nov 10, 2026

Study contacts

Lisa McElroy
principal investigator · Duke University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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