Randomized Controlled Trial of ImmuKnow in Liver Transplantation

Liver Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01764581
• Other study ID #: BolognaCylex01
• Status: Completed
• Phase: N/A
• First received: January 2, 2013
• Last updated: January 7, 2013
• Start date: July 2008
• Est. completion date: March 2012

Study information

• Verified date: October 2010
• Source: University of Bologna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 206
• Est. completion date: March 2012
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Liver Disease
• Liver Diseases

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Bologna

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of adverse events	Comparison of adverse events consisting of allograft rejection, severe infections, graft loss and death between the Control and Interventional groups	12 months posttransplant	Yes