Randomized Controlled Trial of ImmuKnow in Liver Transplantation

Not Applicable

Completed

• Conditions: Liver Disease
• Interventions: Procedure: Tacrolimus regulation according to ImmuKnow values

• Registration Number: NCT01764581
• Lead Sponsor: University of Bologna

Brief Summary

ImmuKnow detects cell-mediated immunity in solid-organ transplant recipients undergoing immunosuppressive therapy. Increasing ImmuKnow values indicate a decrease of immunosuppression and decreasing ImmuKnow values suggest an increase of immunosuppression. The test measures the amount of ATP produced in CD4+ lymphocytes as a biomarker of lymphocyte activation. This study uses the ImmuKnow assay to proactively adjust immunosuppressive therapy in adult liver transplant recipients to reduce the risk of adverse events

Detailed Description

We performed a randomized prospective interventional trial where the Interventional group had immunosuppression modified according to ImmuKnow values. Immunosuppression was decreased by 25% if ImmuKnow values were less than 130 ng/mL ATP. Similarly, immunosuppression was increased by 25% if ImmuKnow values were greater than 450 ng/mL ATP. Immunosuppression of the Control group was managed by the Standard of Care at our institution. ImmuKnow was performed before liver transplant, after surgery and at each clinic visit with the approximate schedule: day 1; weekly, weeks 1-4; week 6; week 8; monthly, months 3-6; and months 9 and 12. ImmuKnow testing was repeated within 7 days of a suspected/confirmed rejection or infection and again within 1 week of resolution.

Study Timeline

• Study Start: 2008-07
• Status Verified: 2010-10
• Primary Completion: 2010-10
• Study Completion: 2012-03
• Study First Submitted: 2013-01-02
• Study First Submitted QC: 2013-01-07
• Last Update Submitted: 2013-01-07
• Study First Posted: 2013-01-09
• Last Update Posted: 2013-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 206

Inclusion Criteria

• consecutive adult liver transplant recipients at our center;
• patients not entered into other studies;
• provided consent.

Exclusion Criteria

• available follow-up;
• consent removed.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tacrolimus dose regulation	Tacrolimus regulation according to ImmuKnow values	Tacrolimus dose was reduced by 25% when ImmuKnow values were below 130 ng/mL ATP and increased by 25% when ImmuKnow values exceeded 450 ng/mL.

Primary Outcome Measures

Name	Time	Method
Comparison of adverse events	12 months posttransplant	Comparison of adverse events consisting of allograft rejection, severe infections, graft loss and death between the Control and Interventional groups