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

Johns Hopkins University

Status and phase

Completed

Phase 3

Phase 2

Conditions

Patients Active and Listed for Lung Transplantation

Treatments

Drug: Zenapax

Study type

Interventional

Funder types

Other

Identifiers

NCT00181142

99-06-30-02

BBIND 8543

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18 to 66 years old

Volunteers

No Healthy Volunteers

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