Randomized Controlled Trial of ImmuKnow in Liver Transplantation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Matteo Ravaioli, University of Bologna
ClinicalTrials.gov Identifier:
NCT01764581
First received: January 2, 2013
Last updated: January 7, 2013
Last verified: October 2010

January 2, 2013
January 7, 2013
July 2008
October 2010   (final data collection date for primary outcome measure)
Comparison of adverse events [ Time Frame: 12 months posttransplant ] [ Designated as safety issue: Yes ]
Comparison of adverse events consisting of allograft rejection, severe infections, graft loss and death between the Control and Interventional groups
Same as current
Complete list of historical versions of study NCT01764581 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Not Provided
 
Randomized Controlled Trial of ImmuKnow in Liver Transplantation
Randomized Controlled Interventional Trial of Immunosuppression Modification Based on the Cylex™ ImmuKnow® Assay in Adult Liver Transplant Recipients

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Liver Disease
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 Name: Prograf
  • 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.
    Intervention: Procedure: Tacrolimus regulation according to ImmuKnow values
  • No Intervention: Control
    immunosuppressive therapy is managed either by standard practice at our center (Control)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
206
March 2012
October 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01764581
BolognaCylex01
Yes
Matteo Ravaioli, University of Bologna
University of Bologna
Not Provided
Study Director: Antonio Daniele Pinna, MD Department of General Surgery and Transplantation; S.Orsola-Malpighi Hospital, University of Bologna
University of Bologna
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP