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

NCT ID: NCT00181142

Last Updated: 2017-12-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-10-31
• Study Completion Date: 2004-12-31

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.

Conditions

Patients Active and Listed for Lung Transplantation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Zenapax

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 66 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John V Conte, M.D.

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins University Hospital

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

99-06-30-02

Identifier Type: -

Identifier Source: secondary_id

BBIND 8543

Identifier Type: -

Identifier Source: org_study_id