drugset / Trial / NCT00564538

A Study of Thymoglobulin and Tacrolimus in Liver Transplant

NCT00564538

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2007-12
Primary completion
Completion
2009-12

Publications

  • Background 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.

Drugs

EvaluationDrugModalityDoseRoute
Comparator Tacrolimus Small molecule Oral
Subject Thymoglobulin Protein / enzyme biologic 1.5 mg/kg

Indications