Fibroscan-Guided Immunosuppression Reduction for Post-Transplant Care

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alberta

Must be taking: Immunosuppressants

Disqualifiers: Autoimmune liver disease, HCV, HBV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 3 months

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find safe ways to reduce the need for long-term immune-suppressing medication in liver transplant recipients. These medications can cause side effects such as kidney problems, diabetes, and heart disease. The trial uses a special scan (fibroscan) to assess the liver's condition and determine if it's safe to lower medication doses. It seeks participants who have experienced no liver rejection issues and have normal blood tests at least two years post-transplant. The goal is to improve overall health and reduce medication side effects. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance post-transplant care and minimize medication side effects.

What prior data suggests that this fibroscan-guided immunosuppression reduction is safe?

Research has shown that many liver transplant patients can safely reduce their use of drugs that suppress the immune system. In some cases, over 40% of carefully selected patients have stopped these drugs completely without any problems. This is important because long-term use of these drugs can lead to kidney problems, diabetes, heart disease, and even cancer.

Doctors use a tool called Fibroscan to measure liver stiffness and fat content, helping them decide who can safely lower their drug doses. This method aims to reduce the risk of side effects from long-term drug use while still preventing the body from rejecting the new liver. Overall, studies suggest that with careful monitoring, reducing these drugs can be safe for qualifying patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the potential of using Fibroscan technology to guide the reduction of immunosuppression medication in post-transplant care. Typically, post-transplant patients need long-term immunosuppressive drugs to prevent organ rejection, but these can have significant side effects. By using Fibroscan, a non-invasive tool that assesses liver stiffness, the hope is to personalize and minimize the use of these medications, potentially reducing side effects while maintaining organ health. This approach could lead to a safer, more tailored post-transplant treatment plan.

What evidence suggests that using Fibroscan for immunosuppression reduction is effective for post-transplant care?

Research has shown that lowering the amount of medication that suppresses the immune system after a liver transplant can be safe for some patients. In this trial, participants in the "Immunosuppression minimization" arm will have their immunosuppression reduced using Fibroscan guidance. Studies indicate that reducing these drugs early on works well for some liver recipients, although completely stopping them is only successful for a few. A Fibroscan, a tool that checks how stiff and fatty the liver is, helps doctors decide if a patient can manage with less medication. This approach may reduce the risk of side effects like kidney problems and heart disease. Overall, carefully reducing these medications could improve long-term health for liver transplant patients. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for individuals who are 18 or older and at least two years post-liver transplant. They should not have autoimmune liver disease, a history of rejection, and must have normal liver-related blood tests. The study aims to safely reduce their lifelong immunosuppression medication.

Inclusion Criteria

It has been over 2 years since my liver transplant.

I am 18 years old or older.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo immunosuppression reduction using FibroScan guidance

3 months

Regular visits for monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment to ensure no rejection

6 months

Periodic visits for assessment

Nested Study

Exploration of the effect of type of immunosuppression on hepatic steatosis using CAP score

What Are the Treatments Tested in This Trial?

Interventions

• Immunsuppression Reduction

Trial Overview

The trial is testing if using Fibroscan—a type of ultrasound that measures liver stiffness and fat content—can help doctors decide who can safely reduce their immunosuppression drugs after a liver transplant without increasing the risk of organ rejection.

How Is the Trial Designed?

Group I: Immunosuppression minimization Experimental Treatment 1 Intervention

will have immunosuppression reduction during the study using fibroscan

Group II: Standard of Care Active Control 1 Intervention

Followed per standard of care

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6482056/

Outcomes of immunosuppression minimization and ...

Early immunosuppression minimization is feasible in selected liver recipients, while complete withdrawal is successful in only a small proportion.

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S0168827823000892

Liver transplantation immunology: Immunosuppression, ...

Outcomes after liver transplantation have continuously improved over the past decades, but long-term survival rates are still lower than in the general ...

3.

frontiersin.org

frontiersin.org/journals/medicine/articles/10.3389/fmed.2022.949833/full

Impact of DSA and immunosuppression minimization on ...

Recent studies have suggested that only high titers of DSA affect the outcome of liver transplantation (8, 10, 11). In simultaneous liver–kidney ...

4.

liver.theclinics.com

liver.theclinics.com/article/S1089-3261(24)00113-2/abstract

Immunosuppression Post-Liver Transplant

Outcomes of immunosuppression minimization and withdrawal early after liver transplantation. Am J Transplant. 2019; 19:1397-1409. Full Text.

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/30506630/

Outcomes of immunosuppression minimization and ... - PubMed

Early immunosuppression minimization is feasible in selected liver recipients, while complete withdrawal is successful in only a small proportion.

6.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0966327425000760

Immunosuppression minimization and withdrawal in liver ...

Liver transplantation typically necessitates the use of life long immunosuppressive drugs, to suppress the immune system and minimize the risk of rejection.

7.

journals.lww.com

journals.lww.com/lt/fulltext/2024/06000/improved_outcomes_of_kidney_after_liver.6.aspx

Improved outcomes of kidney after liver transplantation...

Brennan et al6 demonstrated that up to 87% of patients with renal dysfunction who received LT had improvement in renal function within 1 month of transplant and ...

8.

journal-of-hepatology.eu

journal-of-hepatology.eu/article/S0168-8278(23)00089-2/fulltext

Liver transplantation immunology: Immunosuppression, ...

Outcomes after liver transplantation have continuously improved over the past decades, but long-term survival rates are still lower than in the general ...

9.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07206277

Fibroscan to Guide Post Transplant Immunosuppression ...

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 ...