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Fibroscan to Guide Post Transplant Immunosuppression Minimization

NCT07206277 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-01-08

No results posted yet for this 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.

Conditions

  • Immunosuppression

Interventions

OTHER

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.

Sponsors & Collaborators

  • University of Alberta

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-01
Primary Completion
2027-12-31
Completion
2028-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07206277 on ClinicalTrials.gov