Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07206277

Fibroscan to Guide Post Transplant Immunosuppression Minimization

Led by University of Alberta · Updated on 2026-01-08

50

Participants Needed

1

Research Sites

160 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Fibroscan to Guide Post Transplant Immunosuppression Minimization

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • At least 2 years have passed since liver transplantation
  • Age 18 years or older
Not Eligible

You will not qualify if you...

  • Diagnosis of acute or chronic rejection within the past 12 months
  • Abnormal liver enzymes (ALT > 50) or bilirubin levels (> 19 umol/L)
  • Transplant due to autoimmune liver diseases (autoimmune hepatitis, primary sclerosing cholangitis, primary biliary cholangitis)
  • Presence of hepatitis C virus RNA
  • Presence of hepatitis B virus DNA
  • Presence of class II donor specific antibodies (pre-existing or new)
  • More than 6 years since transplantation
  • Presence of ascites, decompensated heart failure, biliary obstruction
  • Chronic kidney disease with estimated glomerular filtration rate 30 ml/min/1.73m2 or less
  • History of re-transplantation or multi-visceral transplant

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

University of Alberta

Edmonton, Alberta, Canada, T6G2R3

Actively Recruiting

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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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