NCT04318587

Assessment of Donor Derived Cell Free DNA and Utility in Lung Transplantation

Terminated NA Results posted Last updated 25 March 2024

What this trial tests

NA trial testing Allosure in Lung Transplant Failure and Rejection in 40 participants. Terminated before completion.

Timeline

29 June 2020

Primary endpoint
31 December 2022

30 December 2023

Quick facts

Lead sponsor	Pablo Sanchez
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	screening
Enrollment	40
Start date	29 June 2020
Primary completion	31 December 2022
Estimated completion	30 December 2023
Sites	1 location across United States

Drugs / interventions tested

• Allosure

Conditions studied

• Lung Transplant Failure and Rejection — all drugs for Lung Transplant Failure and Rejection →

Sponsor

Pablo Sanchez

Who can join

18 and older, any sex, with Lung Transplant Failure and Rejection. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Primary Graft Dysfunction/Allograft Rejection 24 Hours Post Transplant Primary · 24 hours post transplant

Primary Graft Dysfunction is measured using a combination of radiographic opacification and P:F ratio (ratio of partial pressure of oxygen related to fraction of inhaled oxygen). Grade 0: No opacifications on CXR Grade 1: Opacifications and P:F \> 300 Grade 2: Opacifications and P:F \>200, \< 300 Grade 3: Opacifications and P:F \< 200 If someone requires ECMO, they are automatically a grade 3.

PGD 1

Group	Value	95% CI
Allosure Arm	15

PGD 2

Group	Value	95% CI
Allosure Arm	2

PGD 3

Group	Value	95% CI
Allosure Arm	8

Number of Participants With Primary Graft Dysfunction/Allograft Rejection 48 Hours Post Transplant Primary · 48 hours post transplant

Primary Graft Dysfunction is measured using a combination of radiographic opacification and P:F ratio (ratio of partial pressure of oxygen related to fraction of inhaled oxygen). Grade 0: No opacifications on CXR Grade 1: Opacifications and P:F \> 300 Grade 2: Opacifications and P:F \>200, \< 300 Grade 3: Opacifications and P:F \< 200 If someone requires ECMO, they are automatically a grade 3.

PGD 1

Group	Value	95% CI
Allosure Arm	19

PGD 2

Group	Value	95% CI
Allosure Arm	1

PGD 3

Group	Value	95% CI
Allosure Arm	10

Number of Participants With Primary Graft Dysfunction/Allograft Rejection 72 Hours Post Transplant Primary · 72 hours post transplant

Primary Graft Dysfunction is measured using a combination of radiographic opacification and P:F ratio (ratio of partial pressure of oxygen related to fraction of inhaled oxygen). Grade 0: No opacifications on CXR Grade 1: Opacifications and P:F \> 300 Grade 2: Opacifications and P:F \>200, \< 300 Grade 3: Opacifications and P:F \< 200 If someone requires ECMO, they are automatically a grade 3.

PGD 1

Group	Value	95% CI
Allosure Arm	15

PGD 2

Group	Value	95% CI
Allosure Arm	1

PGD 3

Group	Value	95% CI
Allosure Arm	11

Number of Participants With Allograft Rejection 3 Months Post Transplant Primary · 3 months post transplant

Number of participants that experienced allograft rejection determined by evaluation of biopsy taken during bronchoscopy.

Group	Value	95% CI
Allosure Arm	6

Number of Participants With Allograft Rejection 6 Months Post Transplant Primary · 6 months post transplant

Number of participants that experienced allograft rejection determined by evaluation of biopsy taken during bronchoscopy.

Group	Value	95% CI
Allosure Arm	0

Number of Participants With Allograft Rejection 9 Months Post Transplant Primary · 9 months post transplant

Number of participants that experienced allograft rejection determined by evaluation of biopsy taken during bronchoscopy.

Group	Value	95% CI
Allosure Arm	0

Number of Participants With Allograft Rejection 12 Months Post Transplant Primary · 12 months post transplant

Number of participants that experienced allograft rejection determined by evaluation of biopsy taken during bronchoscopy.

Group	Value	95% CI
Allosure Arm	0

Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) Pre-Transplant Primary · pre-transplant

dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells. Amount of Allosure Donor Derived Cell Free DNA (dd-cDNA) Pre-Transplant

Group	Value	95% CI
Allosure Arm	0.014	± 0.05

Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 24 Hours Post Transplant Primary · 24 hours post-transplant

dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.

Group	Value	95% CI
Allosure Arm	15.4	± 4.5

Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 48 Hours Post Transplant Primary · 48 hours post-transplant

dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.

Group	Value	95% CI
Allosure Arm	11.56	± 5.23

Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 72 Hours Post Transplant Primary · 72 hours post-transplant

dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.

Group	Value	95% CI
Allosure Arm	8.41	± 3.85

Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 1 Week Post Transplant Primary · 1 week post-transplant

dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.

Group	Value	95% CI
Allosure Arm	5.08	± 2.30

Sponsor's own description

The use of Allosure to identify and quantify circulating donor-derived cell-free DNA to quantitate allograft injury in the early post-transplant period and determine its relationship to allograft failure.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Single center study investigating the clinical association of donor-derived cell-free DNA with acute outcomes in lung transplantation.
   Noda K, Snyder ME, Xu Q, Peters D, et al · · 2023 · cited 3× · PMID 38993874 · DOI 10.3389/frtra.2023.1339814