Ignite Creation Date:
2025-12-24 @ 3:07 PM
Ignite Modification Date:
2026-02-20 @ 3:38 PM
Study NCT ID:
NCT00579592
Status:
TERMINATED
Last Update Posted:
2012-06-26
First Post:
2007-12-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Campath, Rituximab, and Myfortic With Short-Course Calcineurin Inhibitor Therapy in Renal Transplanation
Sponsor:
University of Wisconsin, Madison
Organization:
Study Overview
Official Title:
A Pilot Study of Campath-1H Induction Therapy Combined With Rituximab®, Myfortic™ and a Short Course of Calcineurin Inhibitor Therapy to Allow for a Long Term Calcineurin Inhibitor Free Regimen After Renal Transplantation
Status:
TERMINATED
Status Verified Date:
2012-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Higher than expected rate of acute rejection
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 for an indefinite period of time. However, the advantage of a long term, 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. Subjects will receive 2 doses of Campath-1H (30mg given on Day 0 and Day 1) and a single dose of Rituximab (375mg/m2) on Day 0, given intra-operative. Subjects will take maintenance doses of prednisone and enteric coated mycophenolate sodium (Myfortic™). Subject will also be given cyclosporine (Neoral®) therapy for approximately 2 weeks (10-20 days).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: