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
  Purpose

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 Intervention
Liver Disease
Procedure: Tacrolimus regulation according to ImmuKnow values

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by University of Bologna:

Primary Outcome Measures:
  • 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


Enrollment: 206
Study Start Date: July 2008
Study Completion Date: March 2012
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Prograf
No Intervention: Control
immunosuppressive therapy is managed either by standard practice at our center (Control)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01764581

Sponsors and Collaborators
University of Bologna
Investigators
Study Director: Antonio Daniele Pinna, MD Department of General Surgery and Transplantation; S.Orsola-Malpighi Hospital, University of Bologna
  More Information

No publications provided

Responsible Party: Matteo Ravaioli, PhD, MD, University of Bologna
ClinicalTrials.gov Identifier: NCT01764581     History of Changes
Other Study ID Numbers: BolognaCylex01
Study First Received: January 2, 2013
Last Updated: January 7, 2013
Health Authority: Italy: The Italian Medicines Agency

Keywords provided by University of Bologna:
immune monitoring
immune cell function ImmuKnow
randomized controlled trial
immunosuppression management
infection
rejection
liver transplantation
Cylex

Additional relevant MeSH terms:
Liver Diseases
Digestive System Diseases
Tacrolimus
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014