Fibroscan to Guide Post Transplant Immunosuppression Minimization
ConditionImmunosuppression
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Alberta
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
2 years or more post-liver transplant
18 years or older
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Immunosuppression reduction
Other interventionIn 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.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Standard of CareNo intervention 0 interventions
Group B: Immunosuppression minimizationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of participants successfully achieving immunosuppression minimization
Goal 30% reduction in immunosuppression without rejection
Time frame
Immunosuppression reduced over 3 months. Follow up to ensure no rejection at 6 months.Sponsors and contacts
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Source ClinicalTrials.gov