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

Phase 2

Completed

• Conditions: Patients Active and Listed for Lung Transplantation

• Registration Number: NCT00181142
• Lead Sponsor: Johns Hopkins University

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.

Study Timeline

• Study Start: 1999-10
• Primary Completion: 2004-12
• Study Completion: 2004-12
• Study First Submitted: 2005-09-10
• Study First Submitted QC: 2005-09-10
• Study First Posted: 2005-09-16
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-21
• Last Update Posted: 2017-12-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
All cause mortality at 2 years.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Johns Hopkins University Hospital; 🇺🇸 Baltimore, Maryland, United States