NCT06225206

Analysis of Donor-derived Cell Free DNA in Liver Transplant Patients

Retrospective Exploratory Analysis of Donor-derived Cell Free DNA in Liver Transplant Patients

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Methodist Health System · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Determine the levels of Donor-derived (dd)cell-free DNA(cfDNA )in liver transplant recipients with normal liver function tests (LFTs) indicating stable immunosuppression status (IS). Based on this range use the dd-cfDNA levels to determine over or under IS in liver transplant patients to make changes to their IS medication regimen.

Detailed description

dd-cfDNA is a non-invasive method to measure graft function stability in liver transplant patients. Liver biopsy is the standard to determine liver rejection and graft function, but no tests exist currently to be able to help guide the IS regimen in these patients. LFTs are not as specific to determine graft function hence testing dd-cfDNA levels can help guide the Immunosuppression (IS )medications dosing and help identify rejection early.

Conditions

• Liver Transplant Failure

Interventions

Type	Name	Description
BEHAVIORAL	donor-derived cell free DNA in liver	Determine the difference in age, gender, LFTs, IS regimen (tacrolimus/sirolimus/cyclosporin with mycophenolate mofetil (MMF) and /or prednisone) between patients who underwent liver transplant \<1 year PTX and \>1 year PTX

Timeline

• Start date: 2021-07-01
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2024-01-25
• Last updated: 2024-03-28

Locations

1 site across 1 country: United States