The Use of Daclizumab and Anti-Thymocyte Globulin in Lung Transplantation

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
A Phase 3 Study Comparing the Use of Daclizumab vs Thymoglobulin as Induction Therapy in Lung Transplantation

Conditions
-----------------
Patients Active and Listed for Lung Transplantation

Intervention / Treatment
-----------------
* Drug: Zenapax


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients accepted and listed for lung transplantation will be considered for randomization Exclusion Criteria: Patients who demonstrate hemodynamic instability, requiring inotropes for greater than 48 hours prior to transplant Severe reperfusion pulmonary edema or primary graft dysfunction requiring FiO2 of > 50% and PEEP > 10 cm for greater than 48 hours prior to transplant Preoperative renal insufficiency (CrCl < 50 gm.d or serum creatinine > 2.0) Pre-operative panel reactive antibodies PRA Preoperative recipient bacterial or fungal colonization Preoperative antimicrobial suppressive therapy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 66 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Zenapax|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause mortality at 2 years. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1)Freedom from 1st >/= A2 rejection episode and incidence of rejection over the first 2 years post-transplant |  |  | 
| 2)Freedom from infection |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Induciton therapy, Daclizumab, Thymoglobulin, lung transplantation