A Study of Thymoglobulin and Tacrolimus in Liver Transplant (thymo)
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|ClinicalTrials.gov Identifier: NCT00564538|
Recruitment Status : Unknown
Verified November 2007 by University of Nebraska.
Recruitment status was: Enrolling by invitation
First Posted : November 28, 2007
Last Update Posted : November 28, 2007
|Condition or disease||Intervention/treatment||Phase|
|Liver Transplantation Liver Disease Immunosuppression||Drug: anti-thymocyte globulin (rabbit) Drug: tacrolimus||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Study Comparing Thymoglobulin to Tacrolimus in Liver Transplant and Impact on Renal Function|
|Study Start Date :||December 2007|
|Estimated Study Completion Date :||December 2009|
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.
Other Name: thymoglobulin
Active Comparator: 2
patients in arm 2 will not receive thymo induction at time of transplant and will have immediate initiation of tacrolimus
Tacrolimus will be administered orally on post op day #1 as per standard of care.
Other Name: 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00564538
|United States, Nebraska|
|University of Nebraska Medical Center|
|Omaha, Nebraska, United States, 68198|
|Principal Investigator:||Wendy Grant, MD||University of Nebraska|