Randomized Controlled Trial of ImmuKnow in Liver Transplantation

Status Completed

Clinical Trial 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

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01764581
Study type	Interventional
Source	University of Bologna
Contact
Status	Completed
Phase	N/A
Start date	July 2008
Completion date	March 2012

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02798861` - Controlled Attenuation Parameter (CAP) in Liver Allografts
Completed	`NCT01968395` - Pharmacokinetics of Caspofungin After One Dose in Patients With Liver Failure	Phase 4
Completed	`NCT01437969` - Pharmacogenomics Study on IL28B Genetic Variants in Italian Patients With HCV Infection naïve to Treatment.
Recruiting	`NCT00155376` - Intravenous-Morphine and Glucagon-Usage Enhanced MR Cholangiography	Phase 4
Recruiting	`NCT00172705` - Quantitative Diagnosis of Fatty Liver by Dual Energy CT Technique	N/A
Completed	`NCT04185454` - Estimation of Minimum Efficacy Daily Dose of Jarlsberg Cheese	N/A
Completed	`NCT02506335` - Liver Function Measured by HepQuant-SHUNT in the Prediction of Outcomes in Patients With Heart Disease	Early Phase 1
Completed	`NCT02520609` - Dynamic Post-Prandial Metabolism in Patients With Non-Alcoholic Fatty Liver Disease
Completed	`NCT02306018` - Evaluation of a New Calibrated Pulse Wave Analysis Method(EV1000™/volumeView™) for Cardiac Output Monitoring in Adult Liver Transplantation	N/A
Completed	`NCT01970904` - Pharmacokinetics, Pharmacodynamics and Safety of DEB025 Plus Ribavirin in Chronic Hepatitis C Genotype 2 and 3 Treatment naïve Patients	N/A
Completed	`NCT01988753` - Non-invasive Biomarkers of Fibrosis in Pediatric Liver Diseases
Terminated	`NCT00741117` - Conjugated Hyperbilirubinemia and Pulse Oximetry	N/A
Enrolling by invitation	`NCT01483248` - Human Menstrual Blood-derived Mesenchymal Stem Cells for Patients With Liver Cirrhosis	Phase 1/Phase 2
Completed	`NCT00074386` - Kidney and Liver Transplantation in People With HIV	N/A
Completed	`NCT00245830` - Ischemic Preconditioning of Liver in Cadaver Donors	N/A
Completed	`NCT02329821` - Change of Lactate Concentration During Hartmann Solution Infusion for Hepatic Resection	N/A
Completed	`NCT01650181` - Effects of Siliphos-Selenium-Methionine-Alpha Lipoic Acid in Patients With Fatty Liver and Non-alcoholic Steatohepatitis	Phase 4
Completed	`NCT01303549` - Anidulafungin vs Amphotericin B Safety in High Risk Hepatic Transplant Recipients	Phase 4
Completed	`NCT00799851` - A Randomized Controlled Trial Comparing Band Ligation and Cyanoacrylate Injection for Esophageal Varices	Phase 4
Completed	`NCT00058890` - Gabapentin to Treat Itch in Patients With Liver Disease	Phase 3