The Use of Daclizumab and Anti-Thymocyte Globulin in Lung Transplantation
The purpose of this study is to compare outcomes in patients undergoing lung transplantation, using 2 different induction therapies. Primary outcome is survival and secondary outcomes include freedom from infection and freedom from rejection.
Patients Active and Listed for Lung Transplantation
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 3 Study Comparing the Use of Daclizumab Vs Thymoglobulin as Induction Therapy in Lung Transplantation|
- All cause mortality at 2 years.
- 1)Freedom from 1st >/= A2 rejection episode and incidence of rejection over the first 2 years post-transplant
- 2)Freedom from infection
|Study Start Date:||October 1999|
|Estimated Study Completion Date:||December 2004|
Acute and chronic allograft rejection are two of the common problems limiting and complicating the utility of lung transplantation. The timing and frequency of acute rejection has been shown to be a significant risk factor for the development of chronic allograft rejection. As an adjunct to standard triple immunosuppressive therapy, induction therapy is thought to decrease the incidence of acute rejection.Daclizumab is an interleukin 2 receptor (IL-2) antagonist which is FDA approved as an immunosuppressive agent. Thymoglobulin is an anti-lymphocyte immunosuppressive agent that has been shown in other solid organ transplant studies to be successful in delaying the first episode of rejection but has not decreased the incidence of Obliterative Bronchiloitis (chronic rejection)in lung transplantation.
|United States, Maryland|
|Johns Hopkins University Hospital|
|Baltimore, Maryland, United States, 21287|
|Principal Investigator:||John V Conte, M.D.||Johns Hopkins University|