Biomarker-Guided Immunosuppression for Liver Transplant Recipients
(BRITRE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
Researchers are interested in determining whether it is safe to reduce anti-rejection medication by approximately 50% after liver transplantation and whether special blood tests called biomarkers can identify early signs that the body is starting to attack the new liver before it gets hurt.
Who Is on the Research Team?
Abraham Shaked, MD, PhD
Principal Investigator
University of Pennsylvania
Are You a Good Fit for This Trial?
This trial is for people who have received a liver transplant and are currently taking anti-rejection medication. Participants should not have any conditions that would make it unsafe to reduce their medication, as determined by the study doctors.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo CNI dose reduction with immunosuppression minimization guided by either a miRNA-based biomarker or conventional biochemical monitoring
Follow-up
Participants are monitored for safety and effectiveness after treatment, focusing on allograft status and renal function
What Are the Treatments Tested in This Trial?
Trial Overview
The study compares two ways of reducing anti-rejection drugs after liver transplant: one uses special blood tests (biomarkers) to guide when it's safe to lower the dose, while the other relies on standard lab tests. The goal is to see which method works better and keeps patients safe.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants undergo CNI dose reduction with immunosuppression minimization guided by a miRNA-based biomarker in conjunction with conventional biochemical monitoring.
Participants undergo CNI dose reduction with immunosuppression minimization guided by conventional biochemical monitoring alone.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Pennsylvania
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator
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