Steroid Free Immunosuppression in Liver Transplantation
Condition: Liver Cirrhosis; Liver Transplant Disorder
MeSH terms: Liver Cirrhosis
Intervention: Steroids; Basiliximab; Tacrolimus; Enteric-coated Mycophenolic acid (EC-MPA)
Intervention description: Patients randomized to Control group shall be administered steroids as methylprednisolone (Solumedrol) 1000 mg IV during the anhepatic phase. Methylprednisolone will be continued according to the following taper schedule: 50 mg IV every 6 hrs on day 1; 40 mg IV every 6hrs on day 2; 30 mg IV every 6 hrs on day 3; 20 mg IV every 6 hrs on day 4; 20 mg IV every 12 hrs on day 5; and Prednisone 20 mg by mouth or Naso-gastric tube (NGT) on day 6. Prednisone shall be tapered slowly starting at 1 month post-OLT and weaned off completely by 6 months post-OLT.; Basiliximab shall be given as induction therapy at 20 mg IV bolus intra-operatively and on the 4th day after transplantation.; Tacrolimus shall be used as the main maintenance immuno-suppressive drug. It will be given at a dose of 0.15mg/ kg/ day by mouth or through a naso-gastric tube (NGT), starting not earlier than 24 after the transplant but within 48 hrs after reperfusion. The dose shall be adjusted to achieve a trough level of 10-15 ng/ml during the first 30 days after transplantation and lowered to 5-10 ng/ml, thereafter.; This drug may be given in combination with calcineurin inhibitors (tacrolimus) and steroids for maintenance immuno-prophylaxis to prevent rejection. They are particularly useful in recipients with renal dysfunction and neurotoxicity, when there is a need to reduce dose or delay introduction of calcineurin inhibitors. This drug is given at 720 mg PO BID for 3 months.
Intervention MeSH terms: Mycophenolic Acid; Prednisone; Methylprednisolone; Methylprednisolone Hemisuccinate; Tacrolimus; Basiliximab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 72 Years
Healthy volunteers: No
Keywords: steroid-free immunosuppression; liver transplantation

Summary:

      The purpose of this study is to determine whether steroid-related complications can be
      avoided by using steroid-free immuno-suppressive drug regimen after liver transplantation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female patients between 18 and 72 years of age

          -  Male or female patients who are primary cadaveric liver transplant recipients

          -  Cold ischemia time must be <20 hours

          -  Females capable of becoming pregnant must have a negative pregnancy test at baseline
             and are required to practice an approved method of birth control for the duration of
             the study and for a period of three months following discontinuation of study
             medication

          -  Patient has given written informed consent to participate in the study

        Exclusion Criteria:

          -  Patients meeting any of the following criteria at baseline will be excluded from study
             participation

          -  Patients who have previously received an organ transplant

          -  Patients who are recipients of a multiple organ transplants

          -  Women of childbearing potential not using the contraception method(s) specified in
             this study, as well as women who are breastfeeding

          -  Known sensitivity to Simulect or class of Simulect

          -  Patients with severe medical condition(s) that in the view of the investigator
             prohibits participation in the study

          -  Use of any other investigational agent in the last 30 days