Cytokeratin 18 Non-invasive Biomarker for Rejection in Liver Transplant Patients

Liver transplantation is a lifesaving procedure; however, there are chances that the body may reject the organ following liver transplantation, and this remains a significant concern. This rejection of the transplanted, healthy liver tissue further adds to the patient's illness and also increases the related costs of treatment. Currently, liver biopsy is the standard procedure used for diagnosing this rejection. Being an invasive procedure (requiring the introduction of instruments into the body), this procedure also increases the chances of death of the patient. Researchers are looking into the identification of testing methods that can act as a sign of this rejection without requiring the introduction of instruments into the body. This type of testing could also allow for adjusting the doses of drugs given to the patient to decrease the chances of graft failure. A particular event that occurs during rejection in the body is the death of liver cells. Thus, tracking cell death using a blood test would be an important tool in assessing rejection. CK-18 is a protein in the liver cells that is thought to be linked to the changes occurring as a result of cell death. This study will be looking into a new idea of measuring CK-18 levels and compare them to an existing index to develop a reliable test for liver transplant rejection without introducing any instruments into the body. The purpose of this research study is to assess the history and collect blood samples to be tested for measuring CK-18 levels and assess certain other markers in the blood.

NCT Number	NCT06153641
Lead Sponsor	St. Louis University Collaborators: Mid-America Transplant
Conditions	Liver Transplant Rejection, Liver Transplant Failure and Rejection
Enrollment	70 participants
Start Date	2019-04-16
Primary Completion	2025-01-13 (estimated)
Study Completion	2026-03-31 (estimated)
Updated on ClinicalTrials.gov	2025-12-10