Randomized Controlled Trial of ImmuKnow in Liver Transplantation

NCT01764581 | Completed DMC

• 1 other identifier: BolognaCylex01
• Study Type: interventional
• Target: 206
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Liver Disease

Keywords

immune monitoring; immune cell function ImmuKnow; randomized controlled trial; immunosuppression management; infection; rejection; liver transplantation; Cylex

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Tacrolimus dose regulation

EXPERIMENTAL

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

Control

NO INTERVENTION

immunosuppressive therapy is managed either by standard practice at our center (Control)

Interventions

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

Also known as: Prograf

Tacrolimus dose regulation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• consecutive adult liver transplant recipients at our center;
• patients not entered into other studies;
• provided consent.

You may not qualify if:

• available follow-up;
• consent removed.

Sponsors & Collaborators

• University of Bologna: lead

Related Publications (1)

• Ravaioli M, Neri F, Lazzarotto T, Bertuzzo VR, Di Gioia P, Stacchini G, Morelli MC, Ercolani G, Cescon M, Chiereghin A, Del Gaudio M, Cucchetti A, Pinna AD. Immunosuppression Modifications Based on an Immune Response Assay: Results of a Randomized, Controlled Trial. Transplantation. 2015 Aug;99(8):1625-32. doi: 10.1097/TP.0000000000000650.

  PMID: 25757214 DERIVED

MeSH Terms

Conditions

Liver Diseases; Infections; Rejection, Psychology

Interventions

Tacrolimus

Condition Hierarchy (Ancestors)

Digestive System Diseases; Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Study Officials

• Antonio Daniele Pinna, MD

  Department of General Surgery and Transplantation; S.Orsola-Malpighi Hospital, University of Bologna

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, MD

Study Record Dates

• First Submitted: January 2, 2013
• First Posted: January 9, 2013
• Study Start: July 1, 2008
• Primary Completion: October 1, 2010
• Study Completion: March 1, 2012
• Last Updated: January 9, 2013

Record last verified: 2010-10