Ignite Creation Date:
2024-05-05 @ 11:51 PM
Last Modification Date:
2024-10-26 @ 10:40 AM
Study NCT ID:
NCT01433770
Status:
WITHDRAWN
Last Update Posted:
2012-02-22
First Post:
2011-09-08
Brief Title:
Alefacept in Kidney Transplant Recipients
Sponsor:
University Hospitals Cleveland Medical Center
Organization:
University Hospitals Cleveland Medical Center
Study Overview
Official Title:
Effects of Alefacept on Donor-Specific Memory in Kidney Transplant Recipients
Status:
WITHDRAWN
Status Verified Date:
2012-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The drug will no longer be available in the United States
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Alefacept also known as Amevive is a medication approved by the Food and Drug Administration FDA in the United States and other countries for the treatment of psoriasis which is a chronic inflammatory immunological skin condition that can result in chronic dry red patches that are covered in scales Alefacept is approved by the FDA for the treatment of psoriasis but not as an anti-rejection medication in transplant patients It is now being tested in new kidney transplant patients as a supplement to other approved anti-rejection drugs Alefacept will be used as an investigational drug in this study
The reason for this study is to test whether using Alefacept will inhibit T cells known as memory cells using a test named ELISPOT-IFN In patients with psoriasis Alefacept inhibits these memory cells If memory cells specific to your donor can be inhibited by this drug it might prevent rejection and promote acceptance of the transplanted kidney in a unique manner
The reason for this study is to test whether using Alefacept will inhibit T cells known as memory cells using a test named ELISPOT-IFN In patients with psoriasis Alefacept inhibits these memory cells If memory cells specific to your donor can be inhibited by this drug it might prevent rejection and promote acceptance of the transplanted kidney in a unique manner
Detailed Description:
None
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