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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Genzyme, a Sanofi Company
Information provided by:
University of Nebraska
ClinicalTrials.gov Identifier:
NCT00564538
First received: November 27, 2007
Last updated: NA
Last verified: November 2007
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Liver Transplantation
Liver Disease
Immunosuppression
Drug: anti-thymocyte globulin (rabbit)
Drug: tacrolimus
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Study Comparing Thymoglobulin to Tacrolimus in Liver Transplant and Impact on Renal Function

Resource links provided by NLM:


Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • 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 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 [ Time Frame: post op days 1-6, months 3,6, 9, and 12 ]

Estimated Enrollment: 100
Study Start Date: December 2007
Estimated Study Completion Date: December 2009
Arms Assigned Interventions
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 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
Drug: tacrolimus
Tacrolimus will be administered orally on post op day #1 as per standard of care.
Other Name: prograf

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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00564538

Locations
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Sponsors and Collaborators
University of Nebraska
Genzyme, a Sanofi Company
Investigators
Principal Investigator: Wendy Grant, MD University of Nebraska
  More Information

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.

ClinicalTrials.gov Identifier: NCT00564538     History of Changes
Other Study ID Numbers: 424-07
Study First Received: November 27, 2007
Last Updated: November 27, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by University of Nebraska:
liver transplant

Additional relevant MeSH terms:
Liver Diseases
Digestive System Diseases
Antilymphocyte Serum
Tacrolimus
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 29, 2014