NCT07825688

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P75+ for not_applicable

Timeline
33mo left

Started Sep 2026

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress2%
Sep 2026Jun 2029

First Submitted

Initial submission to the registry

September 8, 2026

Completed
7 days until next milestone

Study Start

First participant enrolled

September 15, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 17, 2026

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2029

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2029

Last Updated

September 17, 2026

Status Verified

May 1, 2026

Enrollment Period

2.4 years

First QC Date

September 8, 2026

Last Update Submit

September 12, 2026

Conditions

Delayed Graft Function

Keywords

Kidney TransplantDelayed Graft FunctionDonor-Derived Cell-Free DNA

Outcome Measures

Primary Outcomes (1)

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

    through 90 days post-transplant

Secondary Outcomes (6)

  • Allograft biopsy rate

    first post transplant year

  • Health Care Resource Utilization (hospital length of stay)

    first post transplant year

  • Health Care Resource Utilization (readmission rate)

    first post transplant year

  • Health Care Resource Utilization (days in intensive care unit)

    first post transplant year

  • Dialysis utilization

    90 days after transplant procedure

  • +1 more secondary outcomes

Study Arms (1)

TxAccess Intervention Arm

EXPERIMENTAL

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

Device: TxAccessDiagnostic Test: Donor-Derived Cell-Free DNA (dd-cfDNA)

Interventions

TxAccessDEVICE

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

TxAccess Intervention Arm
Donor-Derived Cell-Free DNA (dd-cfDNA)DIAGNOSTIC_TEST

Blood testing to assess allograft injury and immunologic outcomes.

TxAccess Intervention Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Delayed Graft Function

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Lisa McElroy

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2026

First Posted

September 17, 2026

Study Start

September 15, 2026

Primary Completion (Estimated)

January 31, 2029

Study Completion (Estimated)

June 30, 2029

Last Updated

September 17, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share