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

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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00181142

Enrollment

Registered

2005-09-16

Start date

1999-10-31

Completion date

2004-12-31

Last updated

2017-12-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients Active and Listed for Lung Transplantation

Keywords

Induciton therapy, Daclizumab, Thymoglobulin, lung transplantation

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.

Interventions

DRUGZenapax

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 66 Years

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

Design outcomes

Primary

Measure	Time frame
All cause mortality at 2 years.	—

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026