Withdrawal of Immunosuppression in Pediatric Liver Transplant Recipients
WISP-R
Immunosuppression Withdrawal for Pediatric Living-donor Liver Transplant Recipients (ITN029ST)
1 other identifier
interventional
20
1 country
3
Brief 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 The purpose of this study is to determine whether immunosuppressive drugs can be safely withdrawn over a minimum of 9 months from children who received liver transplants at least 4 years ago.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jun 2006
Longer than P75 for phase_1
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 28, 2006
CompletedFirst Posted
Study publicly available on registry
May 3, 2006
CompletedStudy Start
First participant enrolled
June 5, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2009
CompletedResults Posted
Study results publicly available
July 6, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 13, 2017
CompletedSeptember 20, 2018
August 1, 2018
3.5 years
April 28, 2006
June 8, 2011
August 22, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of Participants Successfully Withdrawn From Immunosuppression
Participants were considered successfully withdrawn from immunosuppression if they remained off immunosuppression for at least one year with normal allograft function.
1 year after completion of immunosuppression withdrawal
Secondary Outcomes (10)
Number of Participants Who Suffered Graft Loss or Died Following Initiation of Immunosuppression Withdrawal
Enrollment through end of study (up to 9.5 years)
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
From the start of immunosuppression withdrawal to first acute rejection, second episode of rejection that did not require treatment, or diagnosis of chronic rejection through end of study (up to 9.5 years)
Immunosuppression-Free Duration
Completion of Withdrawal to either end of trial participation (up to 9.5 years) or time to restarting immunosuppression
Distribution of Histologic Severity Among Rejection Episodes
Start of immunosuppressive withdrawal to rejection through end of study (up to 9.5 years)
Number of Participants Experiencing Adverse Events by Severity
Enrollment through end of study (up to 9.5 years)
- +5 more secondary outcomes
Study Arms (1)
Immunosuppression Withdrawal
EXPERIMENTALRecipients 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. Participants 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
- Willing to participate in this study
You may not qualify if:
- 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
- % increase in dose of current immunosuppressive drug
- HIV infection
- Hepatitis B or C virus infection
- Pregnancy or breastfeeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
University of California, San Francisco
San Francisco, California, 94143, United States
Children's Memorial Hospital
Chicago, Illinois, 60614, United States
Columbia University Medical Center
New York, New York, 10032, United States
Related Publications (4)
Reding R. Long-term complications of immunosuppression in pediatric liver recipients. Acta Gastroenterol Belg. 2005 Oct-Dec;68(4):453-6.
PMID: 16433002BACKGROUNDFeng S, Ekong UD, Lobritto SJ, Demetris AJ, Roberts JP, Rosenthal P, Alonso EM, Philogene MC, Ikle D, Poole KM, Bridges ND, Turka LA, Tchao NK. Complete immunosuppression withdrawal and subsequent allograft function among pediatric recipients of parental living donor liver transplants. JAMA. 2012 Jan 18;307(3):283-93. doi: 10.1001/jama.2011.2014.
PMID: 22253395RESULTPerito ER, Mohammad S, Rosenthal P, Alonso EM, Ekong UD, Lobritto SJ, Feng S. Posttransplant metabolic syndrome in the withdrawal of immunosuppression in Pediatric Liver Transplant Recipients (WISP-R) pilot trial. Am J Transplant. 2015 Mar;15(3):779-85. doi: 10.1111/ajt.13024. Epub 2015 Feb 3.
PMID: 25648649RESULTFeng S, Demetris AJ, Spain KM, Kanaparthi S, Burrell BE, Ekong UD, Alonso EM, Rosenthal P, Turka LA, Ikle D, Tchao NK. Five-year histological and serological follow-up of operationally tolerant pediatric liver transplant recipients enrolled in WISP-R. Hepatology. 2017 Feb;65(2):647-660. doi: 10.1002/hep.28681. Epub 2016 Jul 27.
PMID: 27302659RESULT
Related Links
Results Point of Contact
- Title
- Director, Clinical Research Program
- Organization
- DAIT/NIAID
Study Officials
- PRINCIPAL INVESTIGATOR
Sandy Feng, MD
University of California, San Francisco
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 28, 2006
First Posted
May 3, 2006
Study Start
June 5, 2006
Primary Completion
November 30, 2009
Study Completion
March 13, 2017
Last Updated
September 20, 2018
Results First Posted
July 6, 2011
Record last verified: 2018-08
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Already available to the public.
- Access Criteria
- Available to the public. Study ID is SDY662:WISP-R ITN029ST
Participant level data and additional study materials are available to the public in: 1.) the Immunology Database and Analysis Portal (ImmPort), a long-term archive of clinical and mechanistic data from Division of Allergy, Immunology, and Transplantation (DAIT)-funded grants and contracts and 2.) TrialShare, the Immune Tolerance Network (ITN) Clinical Trials Research Portal.