An interventional study of Tacrolimus regulation according to ImmuKnow values in Liver Disease, sponsored by University of Bologna. Completed. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2013-01-09.
Sponsored by University of Bologna · Not applicable, Interventional, and Treatment
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
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.
2,081 studies on the registry are indexed under Liver Diseases; 390 are open to participants now.
This study's enrollment of 206 is above the median of 50 across 1,323 interventional studies indexed under Liver Diseases.
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Exclusion Criteria:
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
immunosuppressive therapy is managed either by standard practice at our center (Control)
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
Also known as: Prograf
Comparison of adverse events
Comparison of adverse events consisting of allograft rejection, severe infections, graft loss and death between the Control and Interventional groups
Time frame: 12 months posttransplant
No study locations are listed for this record.
This study is completed, as verified in Oct 2010. You cannot join it, but the record below documents what was studied.
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University of Bologna