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

This study has been completed.
Sponsor:
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00181142
First received: September 10, 2005
Last updated: NA
Last verified: August 2004
History: No changes posted
  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 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 3 Study Comparing the Use of Daclizumab Vs Thymoglobulin as Induction Therapy in Lung Transplantation

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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

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

Additional relevant MeSH terms:
Antilymphocyte Serum
Daclizumab
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014