Recruiting

Immunosuppression Minimization

Sponsor:

University of Alberta

Code:

NCT07206277

Conditions

Immunosuppression

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Immunosuppression reduction

Study Details

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

Study ID

NCT07206277

Start date

Dec 1, 2025

Status verified date

Jan, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Standard of Care

Followed per standard of care

experimental: Immunosuppression minimization

will have immunosuppression reduction during the study using fibroscan

Interventions

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.

Primary outcome measure

  • Number of participants successfully achieving immunosuppression minimization [ Time Frame: Immunosuppression reduced over 3 months. Follow up to ensure no rejection at 6 months. ]

Central Contacts and Locations

Locations

University of Alberta

Recruiting

Edmonton, Alberta, Canada, T6G2R3

Contacts

Rahima A Bhanji, MD

780.492.2235rbhanji@ualberta.ca

More Information

Sponsor

University of Alberta

Last update posted

Jan 8, 2026

Last verified

Jan, 2026

Keywords

  • Liver transplantation
  • minimization
  • rejection

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alberta on 2026-01-08.