Tacrolimus Reduction for Liver Transplant
(iSYNAPSE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This is a prospective multi-center, longitudinal study to determine efficacy of 50 percent Immunosuppression (IS) reduction. One hundred fully eligible participants will reduce IS by 50 percent in two steps. Liver tests will be checked every 0.5 months through month 4, once a month through month 12, and every other month through month 18. Liver transplant (LTx) center visits will take place at screening, months 6, 12 and 18 after initiating IS dose reduction. A protocol driven liver biopsy to adjudicate the endpoint will be performed at 18 months. The duration of the study from time of starting IS dose reduction to the primary endpoint assessment is 18 months.
The primary objective is to assess the efficacy of 50 percent IS dose reduction in children with Liver transplants (LTxs)
Who Is on the Research Team?
Sandy Feng, MD, Ph.D.
Principal Investigator
University of California San Francisco School of Medicine: Transplantation
John Bucuvalas, M.D.
Principal Investigator
Icahn School of Medicine at Mount Sinai: Transplantation
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants reduce immunosuppression (IS) by 50 percent in two steps over 18 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
Endpoint Assessment
A protocol-driven liver biopsy to adjudicate the endpoint
What Are the Treatments Tested in This Trial?
Interventions
- Tacrolimus
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Eligible participants will reduce immunosuppression (IS) by 50 percent in two steps. For subjects taking tacrolimus once daily: 1. reduce dose to 75 percent of initial dose for 6 weeks 2. reduce dose to 50 percent of initial dose For subjects taking tacrolimus twice daily: 1. reduce evening such that the total daily dose is 75 percent of the initial dose for 6 weeks 2. stop evening dose For participants taking different doses of tacrolimus in the morning and evening, the clinical site will confer will the protocol chair and PI to determine the schedule for IS reduction
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor
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