A Study of Thymoglobulin and Tacrolimus in Liver Transplant

NCT ID: NCT00564538

Last Updated: 2007-11-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2009-12-31

Brief Summary

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.

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.

Conditions

Liver Transplantation; Liver Disease; Immunosuppression

Keywords

liver transplant

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Patients in arm 1 will receive induction with thymoglobulin at time of transplant with delayed initiation of tacrolimus

Group Type: EXPERIMENTAL

anti-thymocyte globulin (rabbit)

Intervention Type: DRUG

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

patients in arm 2 will not receive thymo induction at time of transplant and will have immediate initiation of tacrolimus

Group Type: ACTIVE_COMPARATOR

tacrolimus

Intervention Type: DRUG

Tacrolimus will be administered orally on post op day #1 as per standard of care.

Interventions

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.

Intervention Type: DRUG

tacrolimus

Tacrolimus will be administered orally on post op day #1 as per standard of care.

Intervention Type: DRUG

Other Intervention Names

thymoglobulin; prograf

Eligibility 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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Nebraska

OTHER

Sponsor Role: lead

Genzyme, a Sanofi Company

INDUSTRY

Sponsor Role: collaborator

Principal Investigators

Wendy Grant, MD

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska

Locations

University of Nebraska Medical Center

Omaha, Nebraska, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

Other Identifiers

424-07

Identifier Type: -

Identifier Source: org_study_id