Phase 1
N=20
Withdrawal of Immunosuppression in Pediatric Liver Transplant Recipients
Liver Transplant · Liver Transplantation
Bottom Line
View on ClinicalTrials.gov: NCT00320606 ↗Enrolled (actual)
20
Serious AEs
65.0%
Results posted
Jul 2011
Primary outcome: Primary: Proportion of Participants Successfully Withdrawn From Immunosuppression — 0.60 Proportion of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Immunosuppression Withdrawal (Drug)
- Age
- Pediatric, Adult · 4+ yrs
- Sex
- All
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Primary completion
- Nov 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Participants Successfully Withdrawn From Immunosuppression |
0.60 | — |
| SECONDARY Number of Participants Who Suffered Graft Loss or Died Following Initiation of Immunosuppression Withdrawal |
— | — |
| SECONDARY Time From Start of Immunosuppression Withdrawal to the First Episode of Acute Rejection, Second Episode of Rejection That Did Not Require Treatment, or to Diagnosis of Chronic Rejection |
211.57 | — |
| SECONDARY Immunosuppression-Free Duration |
75.84 | — |
| SECONDARY Distribution of Histologic Severity Among Rejection Episodes |
3; 2; 0 | — |
| SECONDARY Number of Participants Experiencing Adverse Events by Severity |
19; 18; 17; 6; 0; 0 | — |
| SECONDARY Percent Change From Baseline in Renal Function Measured by the Glomerular Filtration Rate (GFR) |
4.5; 8.7; 20.5; 10.8; 7.3; -3.9 | — |
| SECONDARY Percent Change From Baseline in Total Cholesterol |
-7.9; -0.6; -10.9; -3.0; -10.7; -9.0 | — |
| SECONDARY Percent Change From Baseline in Blood Glucose |
-2.2; 1.0; 1.8; -0.5; 2.0; -3.3 | — |
| SECONDARY Percent Change From Baseline in Systolic Blood Pressure |
2.0; 0.0; 4.3; 3.8; 8.6; 2.8 | — |
| SECONDARY Percent Change From Baseline in Diastolic Blood Pressure |
-7.5; 0.0; -5.4; 1.5; 6.6; 0.0 | — |
Summary
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 The purpose of this study is to determine whether immunosuppressive drugs can be safely withdrawn over a minimum of 9 months from children who received liver transplants at least 4 years ago.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00320606). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.