Steroid Free Immunosuppression in Liver Transplantation - Full Text View

Sponsors and Collaborators:	Thomas Jefferson University Novartis
Information provided by:	Thomas Jefferson University
ClinicalTrials.gov Identifier:	NCT00296244

Purpose

The purpose of this study is to determine whether steroid-related complications can be avoided by using an anti-rejection drug combination without steroids after liver transplantation.

Condition	Intervention	Phase
Liver Cirrhosis Liver Transplant Recipients	Drug: Corticosteroids Other: Steroid Avoidance	Phase IV

MedlinePlus related topics: Cirrhosis Liver Transplantation

Drug Information available for: Corticosteroids

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Factorial Assignment, Safety/Efficacy Study
Official Title:	Steroid Free Immunosuppression in Liver Transplantation

Further study details as provided by Thomas Jefferson University:

Primary Outcome Measures:

graft survival rate [ Time Frame: 6 months, 1 and 2 years ] [ Designated as safety issue: No ]
patient survival rate [ Time Frame: 6 months, 1 and 2 years ] [ Designated as safety issue: No ]
acute rejection rate [ Time Frame: 6 months post-transplant ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Adverse effects of steroids (hypertension, obesity, infection, hyperlipedemia) [ Time Frame: 6 months post-transplant ] [ Designated as safety issue: No ]
Severity of Hepatitis recurrence [ Time Frame: 6 months post-transplant ] [ Designated as safety issue: No ]

Enrollment:	40
Study Start Date:	February 2006
Estimated Study Completion Date:	June 2008
Estimated Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Group 1 (study group)-basiliximab (Simulect), tacrolimus (Prograf)without steroids	Other: Steroid Avoidance Steroids will not be used in this arm.
2: No Intervention Group 2 (control group)- basiliximab (Simulect), tacrolimus (Prograf), with steroids	Drug: Corticosteroids Patients randomized to Group 2 shall be administered 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 NGT on day 6. Prednisone shall be tapered slowly starting at 1 month post-OLT and weaned off completely by 6 months post-OLT.

Arms

Assigned Interventions

1: Active Comparator

Group 1 (study group)-basiliximab (Simulect), tacrolimus (Prograf)without steroids

Other: Steroid Avoidance

Steroids will not be used in this arm.

2: No Intervention

Group 2 (control group)- basiliximab (Simulect), tacrolimus (Prograf), with steroids

Drug: Corticosteroids

Patients randomized to Group 2 shall be administered 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 NGT on day 6. Prednisone shall be tapered slowly starting at 1 month post-OLT and weaned off completely by 6 months post-OLT.

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Eligibility

Ages Eligible for Study:	18 Years to 72 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00296244

Locations

United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107

Sponsors and Collaborators

Thomas Jefferson University

Novartis

Investigators

Principal Investigator:

Carlo Gerardo B Ramirez, M.D.

Thomas Jefferson University

More Information

No publications provided

Responsible Party:	Thomas Jefferson University ( Carlo Ramirez, MD )
Study ID Numbers:	CERL080AUS29
Study First Received:	February 23, 2006
Last Updated:	May 28, 2008
ClinicalTrials.gov Identifier:	NCT00296244 History of Changes
Health Authority:	United States: Food and Drug Administration; United States: Institutional Review Board

Keywords provided by Thomas Jefferson University:

steroid-free immunosuppression
liver transplantation

Study placed in the following topic categories:

Prednisone
Liver Diseases
Digestive System Diseases
Methylprednisolone
Fibrosis

Prednisolone
Methylprednisolone acetate
Prednisolone acetate
Liver Cirrhosis
Methylprednisolone Hemisuccinate

Additional relevant MeSH terms:

Liver Diseases
Digestive System Diseases
Pathologic Processes
Fibrosis
Liver Cirrhosis

ClinicalTrials.gov processed this record on May 06, 2009