Liver transplantation
Conditions
Interventions
Trade Name: ATeGe-Fresenius
Product Name: ATeGe-Fresenius
Product Code: ATeGe
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: INMUNOGLOBULINA DE CONEJO ANTI-LINFOCITOS
Sponsors
Liver Unit, ICMD, Hospital Clinic Barcelona
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1-Age > 18 years 2-Recipient of a primary liver graft 3-Absence of any of our exclusion criteriae Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1-Pretransplant renal failure, defined as serum creatinine > 1,5 mg/dL 2-Severe pretransplant thrombopenia, defined as platelets <50000/mL 3-Combined liver-kidney transplanation 4-Autoimmune hepatitis, primary biliary cirrhosis or primary sclerosing cholangitis as causes of liver transplantation 5-Chronic hepatic encephalopathy 6-Living donor liver transplantation 7-Recipient with human immunodeficiency virus infection 8-Severe pretransplant leukopenia, defined as <1500 leukocytes/mL
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To prospectively determine whether induction treatment with ATeGe-Fresenius in liver transplant recipients creates a pro-tolerogenic state allowing for complete immunosuppression withdrawal or minimization. ;Secondary Objective: 1-To determine the effect of induction treatment plus minimized immunosuppression on graft and patient survival. 2-To determine the impact of induction treatment plus minimized immunosuppression on the development of: acute and chronic allograft rejection, hepatitis C virus graft recurrence, opportunistic infections, bone fractures, kidney failure, tacrolimus-related neurotoxicity, dyslipemia and arterial hypertension. 3-To establish whether the use of ATEGE induction followed by reduced doses of tacrolimus differentially affects anti-donor immune responses and/or promotes the development of T cell dependent immunoregulatory networks. ;Primary end point(s): 1-Feasibility of significantly reducing the dosage of conventional immunosuppression (tacrolimus) employed 1 year after liver transplantation (tacrolimus administered every 48 hours, or daily with through levels below 5 ng/mL). 2-Graft and patient survival 3-Severity of hepatitis C virus recurrence | — |
Countries
Spain
Outcome results
None listed