Steroid Free Immunosuppression in Liver Transplantation
1 other identifier
interventional
40
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Feb 2006
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2006
CompletedFirst Submitted
Initial submission to the registry
February 23, 2006
CompletedFirst Posted
Study publicly available on registry
February 24, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedResults Posted
Study results publicly available
November 19, 2012
CompletedNovember 19, 2012
October 1, 2012
2.2 years
February 23, 2006
July 21, 2011
October 18, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Graft Survival Rate
Percentage of recipients whose liver grafts are still working at the end of 1 and 2 years.
1 and 2 years
Patient Survival Rate
Percentage of recipients who are still alive at the end of 1 and 2 years.
1 and 2 years
Acute Rejection Rate
Biopsy proven acute rejection defined by biochemical and histological changes as well as the need for temporary steroid use occurred in 1 patient in each group both of which were steroid responsive
6 months post-transplant
Secondary Outcomes (3)
Infection as an Adverse Effect of Steroids
3 months post-transplant
Incidence and Severity of HCV Recurrence Post-OLT
6 months post-transplant
New-onset Diabetes Mellitus (NODM) as Secondary Outcome
6 months
Study Arms (2)
Steroid -free immunosuppression
OTHERStudy group - Basiliximab, Tacrolimus, Enteric-coated Mycophenolic acid (EC-MPA)
Steroid containing immunosuppression
OTHERControl group- Basiliximab, Tacrolimus, EC-MPA, steroids
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Thomas Jefferson Universitylead
- Novartis Pharmaceuticalscollaborator
Study Sites (1)
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Carlo Gerardo B Ramirez, MD
- Organization
- Thomas Jefferson University
Study Officials
- PRINCIPAL INVESTIGATOR
Carlo Gerardo B Ramirez, M.D.
Thomas Jefferson University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 23, 2006
First Posted
February 24, 2006
Study Start
February 1, 2006
Primary Completion
May 1, 2008
Study Completion
June 1, 2008
Last Updated
November 19, 2012
Results First Posted
November 19, 2012
Record last verified: 2012-10