RecruitingNot ApplicableNCT07206277

Fibroscan to Guide Post Transplant Immunosuppression Minimization

Use of Transient Elastography to Guide Immunosuppression Minimization Post Liver Transplantation


Sponsor

University of Alberta

Enrollment

50 participants

Start Date

Dec 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Following Liver transplantation, recipients remain on life long immunosuppression. Prolonged exposure to immunosuppression is associated with side effects and complications including kidney dysfunction, diabetes, heart disease and cancer risk. Therefore studies are looking at safe ways to reduce or stop immunosuppression. An individual without autoimmune liver disease (these patients are at higher risk of rejection), without history of rejection, with normal blood tests (liver biochemistry, liver function, etc.) can be eligible for minimization of immunosuppression. A recent study showed use of fibroscan (an Ultrasound, which provides information on liver stiffness (diseased liver is hard while a normal liver is soft) and fat content) provides more objective information to help investigators select individuals who will tolerate immunosuppression minimization. Our goal is to see if use of fibroscan allows the investigators to safely minimize immunosuppression in eligible individuals. The secondary aims are to assess benefit on kidney function, heart disease and risk factors for heart disease.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether using a FibroScan ultrasound device — which measures liver stiffness and fat content non-invasively — can help doctors safely identify liver transplant recipients who can have their immunosuppression (anti-rejection medications) reduced without risk of organ rejection. While long-term immunosuppression saves transplanted organs, it also causes significant side effects including kidney damage, diabetes, heart disease, and cancer, so finding those who can tolerate lower doses would be beneficial. Liver transplant recipients at least 2 years post-transplant, aged 18 or older, without recent rejection, abnormal liver enzymes, autoimmune liver disease, or active viral hepatitis are eligible. Participants will have regular FibroScan measurements used to guide decisions about reducing immunosuppression, with kidney function, metabolic health, and survival tracked over time. This summary was prepared to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERImmunosuppression reduction

In patients with LSM \< 8.4 kPa we will gradually reduce IS by 30% (e.g. if on tacrolimus 6 mg daily, dose will be reduced to 4 mg daily) over three months. In patients with immunosuppression reduction we will perform TE at 4, 7 and 12 months after IS reduction to ensure there is no change in LSM. We will get liver biochemistry every 2 weeks x 4 months to ensure labs remain within normal range. Following this, patients will resume monthly labs.


Locations(1)

University of Alberta

Edmonton, Alberta, Canada

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NCT07206277


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