Liver TransplantPhase 2iSYNAPSENCT07549503
Early Signals of the Transition From Immune Quiescence to Activation in the Liver Allograft Microenvironment and in the Circulation
A Phase 2 study testing Immunosuppression Reduction in people with Liver Transplant, run by National Institute of Allergy and Infectious Diseases (NIAID) at 11 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 3 to 13 years
- Conditions the study is for
- Liver Transplant
- What is being tested?
- Immunosuppression Reduction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 11 sitesUnited States
- Study dates
- 14 May 2026to 1 Oct 2031
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Participant and parent or guardian must be able to understand and provide informed assent and consent, respectively
- Recipient of a living or deceased donor Liver transplant (LTx) at <7 years of age
- > 3 years but <7 years after LTx at the time of study enrollment
- Stable liver tests defined as baseline serum alanine aminotransferase (ALT) level < 30 IU/l and gamma-glutamyl transferase (GGT) level < 50 IU/l (based on the average of the 3 most recent values prior to screening; all must be within 1 year of screening; 2 must be within 6 months of screening)
- No Acute rejection (AR) or chronic rejection within 12 months of enrollment
- Tacrolimus monotherapy for > 6 months with baseline 12-hour trough levels <8 ng/mL (based on the average of 3 values prior to screening; all must be within 1 year of screening; 2 must be within 6 months of screening)
- Participants of childbearing potential must have a negative pregnancy test upon study entry
Who cannot join
- Liver transplant (LTx) for autoimmune disease, including autoimmune hepatitis or primary sclerosing cholangitis
- LTx for hepatitis B or hepatitis C
- Recipient of any other organ transplant or liver re-transplant, except for patients who have a repeat LTx within 30 days of first LTx who are eligible for enrollment
- >=50 percent dose increase in tacrolimus within 12 months of enrollment
- Discontinued a second Immunosuppression (IS) agent within 12 months of enrollment
- Systemic illness requiring chronic or recurrent use of IS for which there is a risk of reactivation if tacrolimus is reduced
Show all 11Show fewer
- Use of medication to treat systemic conditions which in the judgement of the investigator could influence results of the study
- Active or chronic infection requiring treatment
- Inability or unwillingness to comply with the study protocol
- Use of investigational drug within 4 weeks (or 5 half-lives of investigational drug, whichever is longer) of enrollment
- Has any condition that, in the opinion of the investigator, will interfere with safe participation in the trial
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
United States11 sites, 11 recruiting
- Not yet recruiting
Emory University School of Medicine/Children's Healthcare of Atlanta
Atlanta, Georgia, 30307
Jordyn Turner, 404-785-3690, Jordyn.turner@choa.org
- Not yet recruiting
Children's Hospital Colorado
Aurora, Colorado, 80045
Michelle Landis, Michelle.landis@childrenscolorado.org
- Recruiting
Ann and Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Catherine Chapin, 312-227-5511, cchapin@luriechildrens.org
- Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Jennifer Hawkins, 513-636-7818, jennifer.hawkins@cchmc.org
- Not yet recruiting
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, 37232
Carly Bhave, carly.bhave@vumc.org
- Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Puja Patel, 212-659-8039, puja.patel4@mountsinai.org
- Recruiting
Columbia University Medical Center
New York, New York, 10032
Ava Whalen, w3876@cumc.columbia.edu
- Not yet recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 15224
Bryanna Domenick, 267-425-1078, DOMENICKB@CHOP.edu
- Recruiting
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Daniel Pieratt, pierattdw@upmc.edu
- Recruiting
UCSF Benioff Children's Hospital
San Francisco, California, 94143
Emily Stekol Moore, emily.stekol@ucsf.edu
- Recruiting
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007
Iryna Asipenka, Iryna.M.Asipenka@medstar.net
About this study
Official title: Early Signals of the Transition From Immune Quiescence to Activation in the Liver Allograft Microenvironment and in the Circulation (RTB-018)
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)
- Conditions
- Liver Transplant
- Being tested
- Immunosuppression Reduction
- Keywords
- Liver transplant, Immunosuppression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunosuppression ReductionDrug
Prospective multi-center, longitudinal study to determine the success rate of 50% immunosuppression (IS) dose reduction. One hundred fully eligible participants will reduce IS by 50% in two steps
| Study group | Role | What they receive |
|---|---|---|
| IS dose reduction | Experimental | 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 Receives: Drug: Immunosuppression Reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achieving successful 50 percent Immunosuppression (IS) reduction
Defined as meeting both biochemical and histological criteria of stability
Measured: At 18 months
Secondary outcomes (3)
Proportion of Acute Rejection (AR) Episodes Within Each Banff Severity Category
The proportion of acute rejection (AR) episodes within each observed Banff severity category will be measured.
Measured: At 18 months
The proportion of participants who experience Acute rejection (AR)
Defined as either biopsy-proven or clinical AR
Measured: At 18 months
Achieving clinically successful 50 percent Immunosuppression (IS) reduction
Defined as meeting biochemical but not histological criteria of stability
Measured: At 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2026
- Study start14 May 2026
- Primary completion1 Apr 2031 (estimated)
- Study completion1 Oct 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplantStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Sandy Feng, MD, Ph.D., Study chair, University of California San Francisco School of Medicine: TransplantationJohn Bucuvalas, M.D., Study chair, Icahn School of Medicine at Mount Sinai: Transplantation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07549503
- Sponsor's protocol ID
- DAIT RTB-018
- Acronym
- iSYNAPSE
- Status last verified
- Sep 2026
- First submitted
- 16 Apr 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Signals of the Transition From Immune Quiescence to Activation in the Liver Allograft Microenvironment and in the Circulation (RTB-018)
- ClinicalTrials.gov ID
- NCT07549503
- Acronym / sponsor ID
- iSYNAPSE / DAIT RTB-018
- Conditions
- Liver Transplant
- Keywords
- Liver transplant, Immunosuppression
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 14 May 2026 (actual)
- Primary completion
- 1 Apr 2031 (estimated)
- Study completion
- 1 Oct 2031 (estimated)
- First posted
- 24 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IS dose reduction | Experimental | Drug: Immunosuppression ReductionEligible 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 |
Who may qualify
- Ages
- 3 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Participant and parent or guardian must be able to understand and provide informed assent and consent, respectively
- Recipient of a living or deceased donor Liver transplant (LTx) at <7 years of age
- > 3 years but <7 years after LTx at the time of study enrollment
- Stable liver tests defined as baseline serum alanine aminotransferase (ALT) level < 30 IU/l and gamma-glutamyl transferase (GGT) level < 50 IU/l (based on the average of the 3 most recent values prior to screening; all must be within 1 year of screening; 2 must be within 6 months of screening)
- No Acute rejection (AR) or chronic rejection within 12 months of enrollment
Key exclusion criteria (11 listed)
- Liver transplant (LTx) for autoimmune disease, including autoimmune hepatitis or primary sclerosing cholangitis
- LTx for hepatitis B or hepatitis C
- Recipient of any other organ transplant or liver re-transplant, except for patients who have a repeat LTx within 30 days of first LTx who are eligible for enrollment
- >=50 percent dose increase in tacrolimus within 12 months of enrollment
- Discontinued a second Immunosuppression (IS) agent within 12 months of enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immunosuppression ReductionProspective multi-center, longitudinal study to determine the success rate of 50% immunosuppression (IS) dose reduction. One hundred fully eligible participants will reduce IS by 50% in two steps | Drug | IS dose reduction |
Primary outcome
Achieving successful 50 percent Immunosuppression (IS) reduction
Time frame: At 18 months
Defined as meeting both biochemical and histological criteria of stability
3 secondary outcomes
Proportion of Acute Rejection (AR) Episodes Within Each Banff Severity Category
Time frame: At 18 months
The proportion of participants who experience Acute rejection (AR)
Time frame: At 18 months
Achieving clinically successful 50 percent Immunosuppression (IS) reduction
Time frame: At 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Division of Allergy, Immunology, and TransplantationLink provided by the sponsor.
- National Institute of Allergy and Infectious DiseasesLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Liver Transplant
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Prevalence and Development of Liver Dysfunction in Hematopoietic Stem Cell Transplant
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Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
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New Biomarkers for Organ Viability Assessment During Hypothermic Machine Perfusion in Liver Transplantation: the Role of Extemporaneous Histological Examination.
Liver Transplantation (LT), Early Allograft Dysfunction
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Expanding Liver Transplant Immunosuppression Minimization Via Everolimus
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sandy Feng, MD, Ph.D. study chair
University of California San Francisco School of Medicine: Transplantation
John Bucuvalas, M.D. study chair
Icahn School of Medicine at Mount Sinai: Transplantation
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Immunosuppression Reduction in people with Liver Transplant, run by National Institute of Allergy and Infectious Diseases (NIAID) at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ada Chao (415-353-7004, ada.chao@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Achieving successful 50 percent Immunosuppression (IS) reduction (time frame: At 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.