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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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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

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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

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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

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Patients Active and Listed for Lung Transplantation

Keywords

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Induciton therapy, Daclizumab, Thymoglobulin, lung transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Zenapax

Intervention Type DRUG

Eligibility Criteria

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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

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John V Conte, M.D.

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Johns Hopkins University Hospital

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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99-06-30-02

Identifier Type: -

Identifier Source: secondary_id

BBIND 8543