A Study of Thymoglobulin and Tacrolimus in Liver Transplant - Full Text View

Sponsors and Collaborators:	University of Nebraska Genzyme
Information provided by:	University of Nebraska
ClinicalTrials.gov Identifier:	NCT00564538

Purpose

The purpose of this study is to compare kidney function, long term patient and graft survival, and incidence of acute rejection in liver transplant recipients between one group receiving thymoglobulin induction and delayed initiation of tacrolimus and another group of liver transplant recipients having immediate administration of tacrolimus without any induction immunosuppression.

Condition	Intervention	Phase
Liver Transplantation Liver Disease Immunosuppression	Drug: anti-thymocyte globulin (rabbit) Drug: tacrolimus	Phase IV

MedlinePlus related topics: Liver Diseases Liver Transplantation

Drug Information available for: Tacrolimus Tacrolimus anhydrous

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Study Comparing Thymoglobulin to Tacrolimus in Liver Transplant and Impact on Renal Function

Further study details as provided by University of Nebraska:

Primary Outcome Measures:

Evaluation of renal function via Glo-Fil nuclear medicine scan and laboratory parameters [ Time Frame: Post operative day #1, month 6 and month 12 ]

Secondary Outcome Measures:

patient and graft survival, incidence of acute rejection, incidence of active CMV disease, incidence of other infections, any adverse events or serious adverse events associated with the use of thymo induction therapy [ Time Frame: post op days 1-6, months 3,6, 9, and 12 ]

Estimated Enrollment:	100
Study Start Date:	December 2007
Estimated Study Completion Date:	December 2009

Arms	Assigned Interventions
1: Experimental Patients in arm 1 will receive induction with thymoglobulin at time of transplant with delayed initiation of tacrolimus	Drug: anti-thymocyte globulin (rabbit) 1.5mg/kg per dose with the first dose initiated in the operating room prior to reperfusion of the transplanted liver. It will then be administered again on post operative day #1, 3 and 5 for a total cumulative dose of 6mg/kg.
2: Active Comparator patients in arm 2 will not receive thymo induction at time of transplant and will have immediate initiation of tacrolimus	Drug: tacrolimus Tacrolimus will be administered orally on post op day #1 as per standard of care.

Detailed Description:

Renal insufficiency following liver transplantation in adult recipients is a major cause of morbidity and a major contributor to mortality. One of the key factors contributing to this renal dysfunction is the use of calcineurin inhibitors. There is some evidence to suggest that the first 7-10 days following liver transplantation are crucial in terms of renal function and the ability to avoid the use of nephrotoxic agents such as calcineurin inhibitors may have a significant impact on long-term outcome.

Eligibility

Ages Eligible for Study:	19 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Primary liver transplant recipient with Model for End Stage Liver Disease (MELD) criteria documentation
Over 18 years of age
Signed informed consent form
if female of childbearing potential: Must not be lactating Must have negative serum pregnancy test on study day 0 Must have agreed on a reliable and acceptable form of contraception during the study
sexually active males must be practicing an acceptable form of contraception

Exclusion Criteria:

Multiple organ transplants
Prior solid organ or bone marrow transplant recipients
Fulminant hepatic failure
Status 1 transplants
Liver transplant candidates with greater than 6 weeks of dialysis
Patients who in the opinion of the Investigator are not eligible for thymo induction at the time of transplant
Recipients of investigational therapy within 90 days prior to transplant
Know contraindication to administration of rabbit anti-thymocyte globulin
Patients whose medical condition is such that the physician feels it would not be in their best interest to participate in the study
Patients who are unwilling to have a Glofil nuclear medicine scan at specified time points
History of malignancy within 5 years with the exception of:
Adequately treated localized squamous or basal cell carcinoma of the skin without evidence of recurrence, and /or
Hepatocellular carcinoma

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00564538

Locations

United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198

Sponsors and Collaborators

University of Nebraska

Genzyme

Investigators

Principal Investigator:

Wendy Grant, MD

University of Nebraska

More Information

Publications:

1. Fisher NC, Nightingale PG, Gunson BK, Lipkin GW, JM. N. Chronic renal failure following liver transplantation: a retrospective analysis Transplantation 1998; 66 (1): 59. 2. Gonwa TA, Mai ML, Melton LB, et al. End-stage renal disease (ESRD) after orthotopic lvier transplantation (OLTX) using calcineurin-based immunotherapy. Transplantation 2001; 72: 1934. 3. Moreno JM, Cuervas-Mons V, Rubio E, et al. Chronic renal dysfunction after liver transplantation in adult patients: prevelance, risk factors, and impact on mortality. Transplant Proc 2003; 35 (5): 1907.

Study ID Numbers:	424-07
Study First Received:	November 27, 2007
Last Updated:	November 27, 2007
ClinicalTrials.gov Identifier:	NCT00564538
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Nebraska:

liver transplant

Study placed in the following topic categories:

Antilymphocyte Serum
Liver Diseases
Digestive System Diseases
Tacrolimus

Additional relevant MeSH terms:

Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009