A Phase 4 interventional study of anti-thymocyte globulin (rabbit) and tacrolimus in Liver Transplantation, Liver Disease and Immunosuppression, sponsored by University of Nebraska. Status unknown at 1 site in United States. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2007-11-28.
Sponsored by University of Nebraska · Phase 4, Interventional, and Treatment
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.
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.
2,081 studies on the registry are indexed under Liver Diseases; 390 are open to participants now.
This study's planned enrollment of 100 is above the median of 50 across 1,323 interventional studies indexed under Liver Diseases.
Browse Liver Diseases studies →University of Nebraska is the lead sponsor of 473 studies on the registry; 66 are open to participants now.
Of its 75 completed or terminated interventional studies of FDA-regulated products, 46 (61%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients in arm 1 will receive induction with thymoglobulin at time of transplant with delayed initiation of tacrolimus
Drug: anti-thymocyte globulin (rabbit)
patients in arm 2 will not receive thymo induction at time of transplant and will have immediate initiation of tacrolimus
Drug: tacrolimus
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.
Also known as: thymoglobulin
Tacrolimus will be administered orally on post op day #1 as per standard of care.
Also known as: prograf
Evaluation of renal function via Glo-Fil nuclear medicine scan and laboratory parameters
Time frame: Post operative day #1, month 6 and month 12
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
This study is status unknown, as verified in Nov 2007. You cannot join it, but the record below documents what was studied.
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University of Nebraska