Randomized Controlled Trial of ImmuKnow in Liver Transplantation

Sponsor

University of Bologna (Other)

Overall Status

Completed

CT.gov ID

NCT01764581

Collaborator

(none)

206

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Liver Disease	Procedure: Tacrolimus regulation according to ImmuKnow values	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

206 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Randomized Controlled Interventional Trial of Immunosuppression Modification Based on the Cylex™ ImmuKnow® Assay in Adult Liver Transplant Recipients

Study Start Date :

Jul 1, 2008

Actual Primary Completion Date :

Oct 1, 2010

Actual Study Completion Date :

Mar 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tacrolimus dose regulation 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.	Procedure: 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. Further reductions or increases were made after serial measures until ImmuKnow values stabilized between 130 and 450 ng/mL ATP. The values of 130 and 450 ng/mL ATP were previously documented as thresholds for risks of infection and rejection, respectively with a value of 280 ng/mL corresponding with the greatest negative predictive value for either event Other Names: Prograf
No Intervention: Control immunosuppressive therapy is managed either by standard practice at our center (Control)

Arm

Intervention/Treatment

Experimental: Tacrolimus dose regulation

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.

Procedure: 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. Further reductions or increases were made after serial measures until ImmuKnow values stabilized between 130 and 450 ng/mL ATP. The values of 130 and 450 ng/mL ATP were previously documented as thresholds for risks of infection and rejection, respectively with a value of 280 ng/mL corresponding with the greatest negative predictive value for either event

Other Names:

Prograf

No Intervention: Control

immunosuppressive therapy is managed either by standard practice at our center (Control)

Outcome Measures

Primary Outcome Measures

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