Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00181142
Status:
COMPLETED
Last Update Posted:
2017-12-26
First Post:
2005-09-10
Brief Title:
The Use of Daclizumab and Anti-Thymocyte Globulin in Lung Transplantation
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
A Phase 3 Study Comparing the Use of Daclizumab vs Thymoglobulin as Induction Therapy in Lung Transplantation
Status:
COMPLETED
Status Verified Date:
2017-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 rejectionDaclizumab 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 rejectionin lung transplantation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 99-06-30-02 | None | None | None |