Withdrawal of Immunosuppression in Pediatric Liver Transplant Recipients (WISP-R)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Immune Tolerance Network (ITN)
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00320606
First received: April 28, 2006
Last updated: January 20, 2012
Last verified: May 2011
Results First Received: June 8, 2011  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Liver Transplantation
Immunosuppression
Intervention: Procedure: Gradual withdrawal of immunosuppressive medication

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Three centers in the United States enrolled 20 pediatric recipients of parental living-donor liver allografts between June 2006 and August 2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Informed consents were obtained from eligible individuals prior to screening assessments. Participants then underwent procedures at screening to determine eligibility according to inclusion/exclusion criteria.

Reporting Groups
  Description
Immunosuppression Withdrawal Arm Subjects will be tapered off of their single immunosuppression drug (cyclosporine or tacrolimus)

Participant Flow:   Overall Study
    Immunosuppression Withdrawal Arm  
STARTED     20  
COMPLETED     6 [1]
NOT COMPLETED     14  
Adverse Event                 1  
Protocol Violation                 1  
Ongoing in study                 12  
[1] 2 discontinued early, 12 ongoing in study



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Immunosuppression Withdrawal Arm Subjects will be tapered off of their single immunosuppression drug (cyclosporine or tacrolimus)

Baseline Measures
    Immunosuppression Withdrawal Arm  
Number of Participants  
[units: participants]
  20  
Age  
[units: participants]
 
<=18 years     20  
Between 18 and 65 years     0  
>=65 years     0  
Age [1]
[units: Years]
Mean ± Standard Deviation
 
Failed During Withdrawal N=5     9.4  ± 4.6  
Successfully Withdrawn & Met Primary Endpoint N=12     9.0  ± 2.3  
Failed After Withdrawal N=3     6.2  ± 0.8  
Total     8.7  ± 3.0  
Gender, Customized  
[units: participants]
 
Failed During Withdrawal - Female     3  
Failed During Withdrawal - Male     2  
Successfully Withdrawn - Female     4  
Successfully Withdrawn - Male     8  
Failed After Withdrawal - Female     2  
Failed After Withdrawal - Male     1  
Gender  
[units: participants]
 
Female     9  
Male     11  
Region of Enrollment  
[units: participants]
 
United States     20  
[1] Current Immunosuppression Withdrawal Status (Failed During Withdrawal, Successfully Withdrawn and Met Primary Endpoint, Failed After Withdrawal)



  Outcome Measures

1.  Primary:   Proportion of Subjects Successfully Withdrawn From Immunosuppression   [ Time Frame: 1 year after completion of immunosuppression withdrawal ]

2.  Primary:   Proportion of Patients Who Suffer Graft Loss or Die Following Initiation of Immunosuppression Withdrawal   [ Time Frame: 1 year ]
Results not yet posted.   Anticipated Posting Date:   07/2014   Safety Issue:   Yes

3.  Secondary:   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 ]
Results not yet posted.   Anticipated Posting Date:   07/2014   Safety Issue:   Yes

4.  Secondary:   Distribution of Histologic Severity Among Rejection Episodes   [ Time Frame: Immunosuppression to rejection ]
Results not yet posted.   Anticipated Posting Date:   07/2014   Safety Issue:   Yes

5.  Secondary:   Incidence of Adverse Events   [ Time Frame: throughout trial ]
Results not yet posted.   Anticipated Posting Date:   07/2014   Safety Issue:   Yes

6.  Secondary:   Changes in Renal Function, Blood Pressure, Cholesterol Level, and Glucose Control   [ Time Frame: throughout trial ]
Results not yet posted.   Anticipated Posting Date:   07/2014   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Associate Director, Clinical Research Program
Organization: DAIT/NIAID
phone: 301-594-7669
e-mail: DAITClinicalTrialsgov@niaid.nih.gov


Publications of Results:
Other Publications:

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00320606     History of Changes
Other Study ID Numbers: DAIT ITN029ST
Study First Received: April 28, 2006
Results First Received: June 8, 2011
Last Updated: January 20, 2012
Health Authority: United States: Federal Government
United States: Institutional Review Board