Evaluation of the Impact of Reduced Immunosuppression

NCT05238155 | Completed

• 1 other identifier: 041.PHA.2021.D
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Graft-versus-host disease (GVHD) is a life-threatening complication of transplantation. It occurs when the donor graft contains immunologically competent T-cells that recognize the recipient as foreign.

Conditions

Graft Vs Host Disease

Outcome Measures

Primary Outcomes (2)

• Incidence of GVHD at one year post-transplant

  Diagnosis confirmed with donor lymphoid chimerism

  September 12, 2004 to June 30, 2020

• Graft rejection at one year post-transplant

  Diagnosis confirmed by liver biopsy

  September 12, 2004 to June 30, 2020

Study Arms (2)

Orthotopic Liver Transplantation recipients prior to protocol implementation date

Orthotopic Liver Transplantation recipients are discharged following transplantation, they are typically prescribed a triple immunosuppression maintenance regimen, consisting of a calcineurin inhibitor, an antimetabolite, and a corticosteroid.

Drug: antimetabolite

Orthotopic Liver Transplantation recipients after protocol implementation date

Over the last several years, there have been changes made to this protocol, and the current protocol now suggests consideration for the omission of the antimetabolite at discharge if there is a donor-recipient age discrepancy that is greater than 30 years. This change was made with the intention to reduce the risk of GVHD, given that a greater disparity in donor-recipient age may put these patients at a higher risk for GVHD.

Interventions

antimetabolite DRUG

When OLT recipients are discharged following transplantation, they are typically prescribed a triple immunosuppression maintenance regimen, consisting of a calcineurin inhibitor, an antimetabolite, and a corticosteroid. Over the last several years, there have been changes made to this protocol, and the current protocol now suggests

Orthotopic Liver Transplantation recipients prior to protocol implementation date

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients admitted for OLT or combined kidney-liver transplant

You may qualify if:

• ≥ 18 years
• Received OLT or Combined Kidney-Liver Transplant(CKLT) during study period

You may not qualify if:

• Recipients requiring re-transplant within one month post-transplant
• Recipients who died of a cause other than GVHD within one month post-transplant

Sponsors & Collaborators

• Methodist Health System: lead

Study Sites (1)

Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

Location

MeSH Terms

Conditions

Graft vs Host Disease

Interventions

Antimetabolites

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Noxae; Toxic Actions

Study Officials

• Jessica Crotty, PharmD

  Methodist Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2022
• First Posted: February 14, 2022
• Study Start: October 19, 2021
• Primary Completion: July 29, 2025
• Study Completion: July 29, 2025
• Last Updated: March 23, 2026

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)