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

Sponsored by:	Johns Hopkins University
Information provided by:	Johns Hopkins University
ClinicalTrials.gov Identifier:	NCT00181142

Purpose

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.

Condition	Intervention	Phase
Patients Active and Listed for Lung Transplantation	Drug: Zenapax	Phase II Phase III

MedlinePlus related topics: Lung Transplantation

Drug Information available for: Dacliximab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase 3 Study Comparing the Use of Daclizumab Vs Thymoglobulin as Induction Therapy in Lung Transplantation

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:

All cause mortality at 2 years.

Secondary Outcome Measures:

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

Estimated Enrollment:	60
Study Start Date:	October 1999
Estimated Study Completion Date:	December 2004

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.

Eligibility

Ages Eligible for Study:	18 Years to 66 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00181142

Locations

United States, Maryland
Johns Hopkins University Hospital
Baltimore, Maryland, United States, 21287

Sponsors and Collaborators

Johns Hopkins University

Investigators

Principal Investigator:

John V Conte, M.D.

Johns Hopkins University

More Information

Study ID Numbers:	BBIND 8543, 99-06-30-02
Study First Received:	September 10, 2005
Last Updated:	September 10, 2005
ClinicalTrials.gov Identifier:	NCT00181142
Health Authority:	United States: Food and Drug Administration

Keywords provided by Johns Hopkins University:

Induciton therapy, Daclizumab, Thymoglobulin, lung transplantation

Study placed in the following topic categories:

Antilymphocyte Serum
Daclizumab

Additional relevant MeSH terms:

Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009