Randomized Controlled Trial of ImmuKnow in Liver Transplantation

University of Bologna

Status: Completed

Conditions: Liver Disease

Treatments: Procedure: Tacrolimus regulation according to ImmuKnow values

Study type: Interventional

Funder types: Other

Identifiers

NCT01764581

BolognaCylex01

Details and patient eligibility

About

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

Full 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.

Enrollment: 206 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

206 participants in 2 patient groups

Tacrolimus dose regulation

Experimental group

Description:

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.

Treatment:

Procedure: Tacrolimus regulation according to ImmuKnow values

Control

No Intervention group

Description:

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