NCT00564538

A Study of Thymoglobulin and Tacrolimus in Liver Transplant

A Study Comparing Thymoglobulin to Tacrolimus in Liver Transplant and Impact on Renal Function

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University of Nebraska · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.
DRUG	tacrolimus	Tacrolimus will be administered orally on post op day #1 as per standard of care.

Timeline

• Start date: 2007-12-01
• Completion: 2009-12-01
• First posted: 2007-11-28
• Last updated: 2007-11-28

Locations

1 site across 1 country: United States