This trial is active, not recruiting.

Conditions liver transplant, immunosuppression
Treatment gradual withdrawal of immunosuppressive medication
Phase phase 1
Sponsor National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator Immune Tolerance Network (ITN)
Start date May 2006
End date August 2010
Trial size 20 participants
Trial identifier NCT00320606, DAIT ITN029ST


Antirejection medicines, also known as immunosuppressive drugs, are prescribed to organ transplant recipients to prevent their bodies from rejecting the new organ. Long-term use of these drugs places transplant recipients at higher risk of serious infections and certain types of cancer. The purpose of this study is to determine whether immunosuppressive drugs can be safely withdrawn over a minimum of 9 months from children who received liver transplants at least 4 years ago.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Recipients of parental living donor liver transplants 4 or more years prior to trial enrollment, who also had stable allograft function during the preceding 6 months while taking a single immunosuppressive drug were permitted to undergo withdrawal of immunosuppression therapy. With high dose, daily dose reduction by 25% for 8 weeks. With low dose, daily dose reduction by 25% for 4 weeks. Patients are carefully evaluated/monitored throughout the study by assessments including but not limited to liver biopsy, liver tests and clinic visits, alloantibodies, autoantibodies and quantitative immunoglobulin G test results.
gradual withdrawal of immunosuppressive medication
With high dose, daily dose reduction by 25% for 8 weeks. With low dose, daily dose reduction by 25% for 4 weeks.

Primary Outcomes

Proportion of Subjects Successfully Withdrawn From Immunosuppression
time frame: 1 year after completion of immunosuppression withdrawal
Proportion of Patients Who Suffer Graft Loss or Die Following Initiation of Immunosuppression Withdrawal
time frame: 1 year

Secondary Outcomes

Time From Start of Immunosuppression to the First Episode of Acute Rejection or to Diagnosis of Chronic Rejection
time frame: Immunosuppression to first acute rejection or diagnosis of chronic rejection
Distribution of Histologic Severity Among Rejection Episodes
time frame: Immunosuppression to rejection
Incidence of Adverse Events
time frame: throughout trial
Changes in Renal Function, Blood Pressure, Cholesterol Level, and Glucose Control
time frame: throughout trial

Eligibility Criteria

Male or female participants from 4 years up to 18 years old.

Inclusion Criteria for Liver Recipients: - Received liver from living parent donor - Received transplant at least 4 years prior to study entry - Less than 18 years of age at time of transplant - Parent or guardian willing to provide informed consent Inclusion Criteria for Liver Donors: - Willing to participate in this study Exclusion Criteria for Liver Recipients: - Underwent transplant because of liver failure related to autoimmune disease - Underwent transplant of a second organ simultaneously with or after liver transplant OR liver retransplantation - Receiving immunosuppression with more than one drug - 50% increase in dose of current immunosuppressive drug - HIV infection - Hepatitis B or C virus infection - Pregnancy or breastfeeding

Additional Information

Official title Immunosuppression Withdrawal for Pediatric Living-donor Liver Transplant Recipients (ITN029ST)
Principal investigator Sandy Feng, MD
Description In order to prevent the rejection of transplanted organs, transplant recipients are prescribed a strict, lifelong regimen of immunosuppressive drugs. While these drugs help prevent the body from rejecting the transplant, they carry numerous complications, including increased risk of serious infections and certain types of cancer. However, there is mounting evidence that a significant percentage of liver transplant recipients can maintain a healthy, functioning transplant without ongoing immunosuppression. This study will determine whether gradual withdrawal and eventual discontinuation of all immunosuppressive medication can be safely accomplished in children who received a liver transplant from a parent. Twenty eligible patients who were under 18 years old at the time of transplant, whose donor was a parent, and who received the transplant at least four years ago will be enrolled in the study. Liver recipients will have an initial screening assessment consisting of a medical history, liver biopsy, and urine and blood collection. Eligible recipients will be placed on a modified medication schedule to gradually decrease their immunosuppression medication slowly over a 9- to 12-month period, during which time they will be closely monitored by study staff. Immunosuppressive drugs will not be provided by this study. For a minimum of 3 and up to a maximum of 7 years, monthly telephone consultations and quarterly study visits will occur. Visits will include physical exams and blood collection to monitor the children's health during the withdrawal phase. The exact schedule of immunosuppressant withdrawal will be determined by study physicians based on participant's health and immune function test results. Donor and nondonor parents will be asked to each provide one blood sample during the initial study visits for immunologic and genetic testing. *** IMPORTANT NOTICE: *** The National Institute of Allergy and Infectious Diseases and the Immune Tolerance Network do not recommend the discontinuation of immunosuppressive therapy for recipients of cell, organ, or tissue transplants outside of physician-directed, controlled clinical studies. Discontinuation of prescribed immunosuppressive therapy can result in serious health consequences and should only be performed in certain rare circumstances, upon the recommendation and with the guidance of your health care provider.
Trial information was received from ClinicalTrials.gov and was last updated in June 2014.
Information provided to ClinicalTrials.gov by National Institute of Allergy and Infectious Diseases (NIAID).