Early Signals of the Transition From Immune Quiescence to Activation in the Liver Allograft Microenvironment and in the Circulation

Part of paid clinical trials in San Francisco, California.

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Study ID
NCT07549503
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Liver Transplant

Eligibility Criteria

Sex
ALL
Age
3 Years - 13 Years
Healthy Volunteers
Not accepted

Interventions

  • Tacrolimus reduction — PROCEDURE
    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 Details

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)

Key Dates

Start date
May 14, 2026
Status verified
Jun 2026
Primary completion
Apr 1, 2031
Completion
Oct 1, 2031

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: IS dose reduction
    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

Primary Outcome Measure

Achieving successful 50 percent Immunosuppression (IS) reduction [ Time Frame: At 18 months ]

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
UCSF Benioff Children's HospitalSan FranciscoCalifornia94143
Paige Shave
[email protected]
415-514-1170
Children's Hospital ColoradoAuroraColorado80045
Michelle Landis
[email protected]
MedStar Georgetown University HospitalWashington D.C.District of Columbia20007
Iryna Asipenka
[email protected]
Emory University School of Medicine/Children's Healthcare of AtlantaAtlantaGeorgia30307
Jordyn Turner
[email protected]
404-785-3690
Ann and Robert H. Lurie Children's Hospital of ChicagoChicagoIllinois60611
Catherine Chapin
[email protected]
312-227-5511
Columbia University Medical CenterNew YorkNew York10032
Icahn School of Medicine at Mount SinaiNew YorkNew York10029
Puja Patel
[email protected]
212-659-8039
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229
Jennifer Hawkins
[email protected]
513-636-7818
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania15224
Bryanna Domenick
[email protected]
267-425-1078
Monroe Carell Jr. Children's Hospital at VanderbiltNashvilleTennessee37232

Find similar trials in San Francisco, CA

By research site
UCSF Benioff Children's Hospital· San Francisco, CAChildren's Hospital Colorado· Aurora, COMedStar Georgetown University Hospital· Washington D.C., DCEmory University School of Medicine/Children's Healthcare of Atlanta· Atlanta, GAAnn and Robert H. Lurie Children's Hospital of Chicago· Chicago, ILColumbia University Medical Center· New York, NY

Related Studies