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A Study of Thymoglobulin and Tacrolimus in Liver Transplant (thymo)

Primary Purpose

Liver Transplantation, Liver Disease, Immunosuppression

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
anti-thymocyte globulin (rabbit)
tacrolimus
Sponsored by
University of Nebraska
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Transplantation focused on measuring liver transplant

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Nebraska Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

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

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

Outcomes

Primary Outcome Measures

Evaluation of renal function via Glo-Fil nuclear medicine scan and laboratory parameters

Secondary Outcome Measures

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

Full Information

First Posted
November 27, 2007
Last Updated
November 27, 2007
Sponsor
University of Nebraska
Collaborators
Genzyme, a Sanofi Company
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1. Study Identification

Unique Protocol Identification Number
NCT00564538
Brief Title
A Study of Thymoglobulin and Tacrolimus in Liver Transplant
Acronym
thymo
Official Title
A Study Comparing Thymoglobulin to Tacrolimus in Liver Transplant and Impact on Renal Function
Study Type
Interventional

2. Study Status

Record Verification Date
November 2007
Overall Recruitment Status
Unknown status
Study Start Date
December 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University of Nebraska
Collaborators
Genzyme, a Sanofi Company

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Transplantation, Liver Disease, Immunosuppression
Keywords
liver transplant

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Patients in arm 1 will receive induction with thymoglobulin at time of transplant with delayed initiation of tacrolimus
Arm Title
2
Arm Type
Active Comparator
Arm Description
patients in arm 2 will not receive thymo induction at time of transplant and will have immediate initiation of tacrolimus
Intervention Type
Drug
Intervention Name(s)
anti-thymocyte globulin (rabbit)
Other Intervention Name(s)
thymoglobulin
Intervention Description
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
Intervention Name(s)
tacrolimus
Other Intervention Name(s)
prograf
Intervention Description
Tacrolimus will be administered orally on post op day #1 as per standard of care.
Primary Outcome Measure Information:
Title
Evaluation of renal function via Glo-Fil nuclear medicine scan and laboratory parameters
Time Frame
Post operative day #1, month 6 and month 12
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wendy Grant, MD
Organizational Affiliation
University of Nebraska
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States

12. IPD Sharing Statement

Citations:
Citation
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.
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A Study of Thymoglobulin and Tacrolimus in Liver Transplant

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