Fibroscan to Guide Post Transplant Immunosuppression Minimization

NCT07206277 | Recruiting DMC

• 1 other identifier: Pro00148986
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Liver transplantation; minimization; rejection

Outcome Measures

Primary Outcomes (1)

• Number of participants successfully achieving immunosuppression minimization

  Goal 30% reduction in immunosuppression without rejection

  Immunosuppression reduced over 3 months. Follow up to ensure no rejection at 6 months.

Study Arms (2)

Standard of Care

NO INTERVENTION

Followed per standard of care

Immunosuppression minimization

EXPERIMENTAL

will have immunosuppression reduction during the study using fibroscan

Other: Immunosuppression reduction

Interventions

Immunosuppression reduction OTHER

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.

Immunosuppression minimization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or more post-liver transplant
• years or older

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G2R3, Canada

RECRUITING

MeSH Terms

Conditions

Rejection, Psychology

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2025
• First Posted: October 3, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: January 8, 2026

Record last verified: 2026-01

Locations

CA (1)