Withdrawal of Immunosuppression in Pediatric Liver Transplant Recipients - Study Results

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

This study is ongoing, but not recruiting participants.

Study NCT00320606 Information provided by National Institute of Allergy and Infectious Diseases (NIAID)

First Received on April 28, 2006. Last Updated on January 20, 2012 History of Changes

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

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

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Successfully Withdrawn & Met Primary Endpoint N=12	9.0 ± 2.3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 ]

Show Outcome Measure 1

2. Primary:

Proportion of Patients Who Suffer Graft Loss or Die Following Initiation of Immunosuppression Withdrawal [ Time Frame: 1 year ]