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

November 27, 2007 updated by: University of Nebraska

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • University of Nebraska Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
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 Names:
  • thymoglobulin
Active Comparator: 2
patients in arm 2 will not receive thymo induction at time of transplant and will have immediate initiation of tacrolimus
Drug: tacrolimus
Tacrolimus will be administered orally on post op day #1 as per standard of care.
Other Names:
  • prograf

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluation of renal function via Glo-Fil nuclear medicine scan and laboratory parameters
Time Frame: Post operative day #1, month 6 and month 12
Post operative day #1, month 6 and month 12

Secondary Outcome Measures

Outcome Measure
Time Frame
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
post op days 1-6, months 3,6, 9, and 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nebraska

Collaborators

Genzyme, a Sanofi Company

Investigators

  • Principal Investigator: Wendy Grant, MD, University of Nebraska

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Study Completion (Anticipated)

December 1, 2009

Study Registration Dates

First Submitted

November 27, 2007

First Submitted That Met QC Criteria

November 27, 2007

First Posted (Estimate)

November 28, 2007

Study Record Updates

Last Update Posted (Estimate)

November 28, 2007

Last Update Submitted That Met QC Criteria

November 27, 2007

Last Verified

November 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 424-07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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