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

• Sponsor: Johns Hopkins University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00181142
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Actual Duration (Months): 62
• Patients Per Site Per Month: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Patients Active and Listed for Lung Transplantation	Drug: Zenapax	Phase 2/Phase 3

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 Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 3 Study Comparing the Use of Daclizumab vs Thymoglobulin as Induction Therapy in Lung Transplantation
• Actual Study Start Date: Oct 1, 1999
• Actual Primary Completion Date: Dec 1, 2004
• Actual Study Completion Date: Dec 1, 2004

Outcome Measures

Primary Outcome Measures

1. All cause mortality at 2 years. []

Secondary Outcome Measures

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

2. 2)Freedom from infection []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 66 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT00181142
• Other Study ID Numbers: BBIND 8543; 99-06-30-02
• First Posted: Sep 16, 2005
• Last Update Posted: Dec 26, 2017
• Last Verified: Dec 1, 2017

• Keywords provided by Johns Hopkins University: Induciton therapy, Daclizumab, Thymoglobulin, lung transplantation
• Additional relevant MeSH terms: Daclizumab

Study Results

No Results Posted as of Dec 26, 2017