Randomized Controlled Trial of ImmuKnow in Liver Transplantation

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

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Key information

Conditions

Liver Disease Behavior Digestive System Diseases Infections Liver Diseases Rejection, Psychology Social Behavior

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tacrolimus regulation according to ImmuKnow values

Procedure

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

Primary outcomes

Comparison of adverse events

Time frame: 12 months posttransplant

Comparison of adverse events consisting of allograft rejection, severe infections, graft loss and death between the Control and Interventional groups

Sponsors and collaborators

Lead sponsor

University of Bologna

Other

Registry information

Official study title

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

Important dates

Study start: 2008
Primary completion: 2010
Study completion: 2012
First posted: Jan 9, 2013
Registry last updated: Jan 9, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed