Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00214266
Status:
COMPLETED
Last Update Posted:
2018-05-30
First Post:
2005-09-13
Brief Title:
A Pilot Study of Campath-1H Induction Therapy Combined With CellCept Therapy to Allow for a Calcineurin Inhibitor Free Regimen After Renal Transplantation
Sponsor:
University of Wisconsin Madison
Organization:
University of Wisconsin Madison
Study Overview
Official Title:
A Pilot Study of Campath-1H Induction Therapy Combined With CellCept Therapy to Allow for a Calcineurin Inhibitor Free Regimen After Renal Transplantation
Status:
COMPLETED
Status Verified Date:
2018-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The hypothesis of this study is that lymphocyte depletion by Campath-1H and rituximab will obviate the need for long-term calcineurin inhibitors in renal transplantation Most successful strategies to date have relied on the use of either tacrolimus or cyclosporine However the advantage of a calcineurin inhibitor free regimen may include improved renal allograft function a lower incidence of hypertension diabetes and less drug related side effects This is a non-randomized open-label pilot trial in 30 adult renal transplant patients
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