Fibroscan to Guide Post Transplant Immunosuppression Minimization

NCT07206277 · tracked via the Priya Life Science Canada tracker

Sponsor

University of Alberta

Phase

Not applicable

Started

2025-12-01

Last updated

2026-01-08

Condition(s) studied

Immunosuppression

Investigational drug(s) / intervention(s)

Immunosuppression reduction

Immunosuppression 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.

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * 2 years or more post-liver transplant * 18 years or older Exclusion Criteria: * diagnosis of either acute or chronic rejection in the past 12 months * abnormal liver enzymes (ALT \> 50; bilirubin \> 19 umol/L) * transplant for autoimmune liver disease (autoimmune hepatitis, primary sclerosing cholangitis, and primary biliary cholangitis) * presence of HCV RNA * presence of HBV DNA * presence of class II donor specific antibodies (DSA; pre-existing or de novo) * beyond 6 years of transplantation * presence of ascites, decompensated heart failure, biliary obstruction, CKD (bl eGFR 30 ml/min/1.73m2 or less), re-transplantation, or multi-visceral transplant.

Primary outcome measure(s)

Number of participants successfully achieving immunosuppression minimization — Immunosuppression reduced over 3 months. Follow up to ensure no rejection at 6 months.
Goal 30% reduction in immunosuppression without rejection

Trial sites (1)

Facility	City	Region	Status
University of Alberta	Edmonton	Alberta	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07206277 on ClinicalTrials.gov ↗ ← All trials in Canada