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

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ClinicalTrials.gov Identifier: NCT00181142
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : December 26, 2017
Information provided by (Responsible Party):
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.

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
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 : October 1999
Primary Completion Date : December 2004
Study Completion Date : December 2004

Resource links provided by the National Library of Medicine

Drug Information available for: Daclizumab
U.S. FDA Resources

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 66 Years   (Adult, Senior)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00181142

United States, Maryland
Johns Hopkins University Hospital
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Principal Investigator: John V Conte, M.D. Johns Hopkins University

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00181142     History of Changes
Other Study ID Numbers: BBIND 8543
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: December 26, 2017
Last Verified: December 2017

Keywords provided by Johns Hopkins University:
Induciton therapy, Daclizumab, Thymoglobulin, lung transplantation

Additional relevant MeSH terms:
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents