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Purpose

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)

Condition

Eligibility

Eligible Ages
Between 3 Years and 13 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Participant and parent or guardian must be able to understand and provide informed assent and consent, respectively 2. Recipient of a living or deceased donor Liver transplant (LTx) at <7 years of age 3. > 3 years but <7 years after LTx at the time of study enrollment 4. 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) 5. No Acute rejection (AR) or chronic rejection within 12 months of enrollment 6. 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) 7. Participants of childbearing potential must have a negative pregnancy test upon study entry

Exclusion Criteria

  1. Liver transplant (LTx) for autoimmune disease, including autoimmune hepatitis or primary sclerosing cholangitis 2. LTx for hepatitis B or hepatitis C 3. 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 4. >=50 percent dose increase in tacrolimus within 12 months of enrollment 5. Discontinued a second Immunosuppression (IS) agent within 12 months of enrollment 6. Systemic illness requiring chronic or recurrent use of IS for which there is a risk of reactivation if tacrolimus is reduced 7. Use of medication to treat systemic conditions which in the judgement of the investigator could influence results of the study 8. Active or chronic infection requiring treatment 9. Inability or unwillingness to comply with the study protocol 10. Use of investigational drug within 4 weeks (or 5 half-lives of investigational drug, whichever is longer) of enrollment 11. Has any condition that, in the opinion of the investigator, will interfere with safe participation in the trial

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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
  • Procedure: Tacrolimus reduction
    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

Recruiting Locations

Ann and Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois 60611
Contact:
Catherine Chapin
312-227-5511
cchapin@luriechildrens.org

Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio 45229
Contact:
Jennifer Hawkins
513-636-7818
jennifer.hawkins@cchmc.org

More Details

Status
Recruiting
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

Study Contact

Ada Chao
415-353-7004
ada.chao@ucsf.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.