A Study of Thymoglobulin and Tacrolimus in Liver Transplant

Liver Transplantation Clinical Trial

— thymo  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT00564538
• Other study ID #: 424-07
• Status: Enrolling by invitation
• Phase: Phase 4
• First received: November 27, 2007
• Last updated: November 27, 2007
• Start date: December 2007
• Est. completion date: December 2009

Study information

• Verified date: November 2007
• Source: University of Nebraska
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Immunosuppression
• Liver Disease
• Liver Diseases
• Liver Transplantation

Intervention

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

Locations

Country	Name	City	State
United States	University of Nebraska Medical Center	Omaha	Nebraska

Sponsors (2)

Lead Sponsor	Collaborator
University of Nebraska	Genzyme, a Sanofi Company

Country where clinical trial is conducted

United States, 

References & Publications (1)

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of renal function via Glo-Fil nuclear medicine scan and laboratory parameters		Post operative day #1, month 6 and month 12
Secondary	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		post op days 1-6, months 3,6, 9, and 12