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

Liver Transplant Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06225206
• Other study ID #: 023.HEP.2023.D
• Status: Recruiting
• Start date: July 1, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: Methodist Health System
• Contact: Kavya Vinod Mankulangara, PharmD
• Phone: 214-947-4681
• Email: MHSIRB[@]mhd.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age: =18 years

2. The patient underwent a liver transplant.

3. The patient at least has one level of dd-cfDNA documented

Exclusion Criteria:

• Patient not meeting the inclusion criteria will be excluded.

Related Conditions & MeSH terms

• Liver Transplant Failure

Intervention

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

Locations

Country	Name	City	State
United States	Methodist Dallas Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Methodist Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	dd-cfDNA range in liver transplant patients	Determine the dd-cfDNA in liver transplant patients with stable IS collected from July 2021 to July 2024 and compare the range between patients with <1-year post-transplant (PTX) and >1-year PTX by chart review using Methodist hospital data system.	1 year
Secondary	Demographics: age (years), gender (male/female), race (Caucasian, Black, Hispanic, Asian, Other)	Demographics differences in patients who underwent liver transplant less than 1 year of PTX and more than 1 year PTX	1 year
Secondary	Days post-transplant at first dd-cfDNA	Number of days post transplant at first dd-cfDNA	1 year
Secondary	LFTs: Alanine transaminase(ALT), Aspartate transaminase(AST),Alkaline phosphatase( ALP), total bilirubin (Tbili)	looking at the liver function tests in patients who underwent liver transplant less than 1 year of PTX and more than 1 year PTX	1 year
Secondary	Serum Creatinine	Measuring the serum creatinine levels	1 year