Recruiting

Cell Free DNA

Sponsor:

Methodist Health System

Code:

NCT06225206

Conditions

Liver Transplant Failure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

donor-derived cell free DNA in liver

Study Details

Brief 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.

Conditions

Liver Transplant Failure

Study ID

NCT06225206

Start date

Jul 1, 2021

Status verified date

Jan, 2024

Completion date

Dec 31, 2024

Anticipated

Primary completion date

Dec 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Interventions

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

Primary outcome measure

  • dd-cfDNA range in liver transplant patients [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Kavya Vinod Mankulangara, PharmD

214-947-4681MHSIRB@mhd.com

Bethany Brauer, MPH

214-947-4681mhsirb@mhd.com

Locations

Methodist Dallas Medical Center

Recruiting

Dallas, Texas, United States, 75203

More Information

Sponsor

Methodist Health System

Last update posted

Mar 28, 2024

Last verified

Jan, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Methodist Health System on 2024-03-28.