Actively Recruiting
Use of Transient Elastography to Guide Immunosuppression Minimization After Liver Transplantation
Led by University of Alberta · Updated on 2026-01-08
50
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of transient elastography (FibroScan), a non-invasive ultrasound tool that measures liver stiffness and fat content, to guide the reduction of immunosuppression in stable liver transplant recipients. Long-term immunosuppression after liver transplantation can cause side effects such as kidney problems, diabetes, heart disease, and increased cancer risk. This study aims to see if FibroScan can help safely minimize immunosuppression, especially in individuals without autoimmune liver disease or recent rejection episodes. Participants will be randomly assigned to either continue standard care or undergo immunosuppression reduction guided by FibroScan results. For those with liver stiffness measurement (LSM) below 8.4 kPa, immunosuppression will be gradually reduced by about 30% over three months. These patients will have FibroScan assessments at 4, 7, and 12 months after reduction, along with frequent liver blood tests to monitor liver health and ensure no rejection occurs. During the study, participants will have liver function tests every two weeks for the first four months, then monthly afterward. Researchers will track the number of patients who successfully reduce immunosuppression without rejection over six months. Secondary goals include assessing effects on kidney function, metabolic syndrome, heart disease risk factors, cancer, and overall graft and patient survival. The total duration of follow-up varies with monitoring extending up to at least one year after immunosuppression reduction.
CONDITIONS
Brief Title
Fibroscan to Guide Post Transplant Immunosuppression Minimization
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 2 years post-liver transplant
- 18 years of age or older
You will not qualify if you...
- Acute or chronic rejection in the past 12 months
- Abnormal liver enzymes (ALT > 50; bilirubin > 19 umol/L)
- Transplant due to autoimmune liver disease (autoimmune hepatitis, primary sclerosing cholangitis, primary biliary cholangitis)
- Presence of HCV RNA
- Presence of HBV DNA
- Presence of class II donor specific antibodies (DSA; pre-existing or new)
- More than 6 years since transplantation
- Presence of ascites, decompensated heart failure, biliary obstruction, chronic kidney disease (eGFR ≤ 30 ml/min/1.73m2), re-transplantation, or multi-visceral transplant history
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 3 months
Participants undergo immunosuppression minimization guided by FibroScan (Transient Elastography). In those with liver stiffness measurement (LSM) below 8.4 kPa, immunosuppression is gradually reduced by 30% over three months with close monitoring.
Liver biochemistry every 2 weeks for 4 months; FibroScan at 4, 7, and 12 months after immunosuppression reduction
Duration - Up to 6 months after immunosuppression reduction
Participants are followed up after immunosuppression minimization to ensure safety and monitor for rejection and other outcomes.
Monthly laboratory tests
Trial Site Locations
Total: 1 location
1
University of Alberta
Edmonton, Alberta, Canada, T6G2R3
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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