Health TrialsbyHealthPanel

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

ConditionDelayed Graft Function
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDuke University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

450 Participants
are divided into 1 treatment group
Group A: TxAccess Intervention ArmExperimental treatment 2 interventions

Trial 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

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Duke University

Lead sponsor

CareDx, Inc.

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: