Delayed CNI-based Immunosuppression With Advagraf After MELD-based Liver Transplantation (IMUTECT)
|ClinicalTrials.gov Identifier: NCT01781195|
Recruitment Status : Unknown
Verified May 2015 by Peter Schemmer, Heidelberg University.
Recruitment status was: Recruiting
First Posted : January 31, 2013
Last Update Posted : May 28, 2015
|Condition or disease|
|Liver Graft Dysfunction|
The MELD-score (model of end stage liver disease) was designed to estimate the prognosis after TIPS (transjugular intrahepatic porto-systemic shunt). Nowadays it is the key-score for patients awaiting a liver graft and consists of serum-creatinine, serum-bilirubine and the INR-ratio with values between 6-40. The MELD-based liver allocation follows the sickest patient first strategy which significantly decreased outcome after liver transplantation (LTx) in Germany. There is evidence that the immune competence of very sick patients is decreased. Monocytic HLA-DR status is a marker for the function of the immune system. A reduced monocytic HLA-DR expression is indicative for a suppressed immune system.
Blood levels of Advagraf are slowly increased during the first week until the aimed tacrolimus trough levels are reached. Since therapeutic tacrolimus trough levels are reached not before the end of the first week after transplantation this is a concept for prolonged-release immunosuppression.
We assume, that high-MELD patients (MELD >20) undergoing LTx are immunosuppressed per se. Thus prolonged-release low-dose immunosuppression with Advagraf would decrease both- infection rate (CMV-reactivation, wound infection urinary tract infections, pneumonia, etc.) and side effects of immunosuppression. The immune capacity of patients will be determined by the measurement of monocytic HLA-DR status. To ensure that graft function is not impaired due to rejection episodes, liver function will be determined with the LiMAx-test, a routine procedure in our institution. After 13-C-Methacetin is given to the patient, it is metabolized to paracetamol and 13CO2 by the enzyme CYP1A2 which is localized in hepatocytes. The 13CO2/12CO2 ratio in the exhaled air correlates with liver function.
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|Official Title:||Effect of Delayed CNI-based Immunosuppression With Advagraf on Liver Function After MELD-based Liver Transplantation|
|Study Start Date :||February 2013|
|Estimated Primary Completion Date :||August 2015|
|Estimated Study Completion Date :||December 2015|
50 patients after liver transplantation (25 with a MELD-score ≤20 and 25 patients with a MELD-score >20) under CNI-based immunosuppression with Advagraf
- infection rate (CMV reactivation, wound infection, urinary tract infection, pneumonia) [ Time Frame: 1-year follow-up per patient ]clinical visit: infection rate (CMV reactivation, wound infection, urinary tract infection, pneumonia)
- liver function (LiMAx) [ Time Frame: one week ]LiMAx test before liver transplantation, and on postoperative days 1, 3, 7
- HLA-DR status [ Time Frame: one week ]HLA-DR status will be measured before liver transplantation and on postoperative days 3, 5, 7.
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01781195
|Contact: Peter Schemmer, Prof.||+firstname.lastname@example.org|
|Contact: Georgios Polychronidis, MD||+4962215637727||Georg.email@example.com|
|University Surgical Clinic||Recruiting|
|Heidelberg, Germany, 69120|
|Contact: Peter Schemmer, Prof. +4962215636500 Peter.firstname.lastname@example.org-Heidelberg.de|
|Contact: Daniela Hall +4962215636805 Daniela.email@example.com-Heidelberg.de|
|Principal Investigator:||Peter Schemmer, Prof.||University Hospital Heidelberg|