A Study of Thymoglobulin and Tacrolimus in Liver Transplant

NCT00564538 | Unknown Phase 4 DMC

• 1 other identifier: 424-07
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Transplantation; Liver Disease; Immunosuppression

Keywords

liver transplant

Outcome Measures

Primary Outcomes (1)

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

  Post operative day #1, month 6 and month 12

Secondary Outcomes (1)

• 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

Study Arms (2)

1

EXPERIMENTAL

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

Drug: anti-thymocyte globulin (rabbit)

2

ACTIVE COMPARATOR

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

Drug: tacrolimus

Interventions

anti-thymocyte globulin (rabbit) DRUG

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.

Also known as: thymoglobulin

1

tacrolimus DRUG

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

Also known as: prograf

2

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nebraska: lead
• Genzyme, a Sanofi Company: collaborator

Study Sites (1)

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Related 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.

  BACKGROUND

MeSH Terms

Conditions

Liver Diseases

Interventions

Antilymphocyte Serum; thymoglobulin; Tacrolimus

Condition Hierarchy (Ancestors)

Digestive System Diseases

Intervention Hierarchy (Ancestors)

Immune Sera; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Biological Products; Complex Mixtures; Macrolides; Lactones; Organic Chemicals

Study Officials

• Wendy Grant, MD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 27, 2007
• First Posted: November 28, 2007
• Study Start: December 1, 2007
• Study Completion: December 1, 2009
• Last Updated: November 28, 2007

Record last verified: 2007-11

Locations

US (1)