Ignite Creation Date:
2024-05-05 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00147381
Status:
COMPLETED
Last Update Posted:
2012-06-19
First Post:
2005-09-06
Brief Title:
Effectiveness and Safety of Campath in Combination With Tacrolimus Monotherapy to Prevent Kidney Graft Rejection
Sponsor:
Dr Claudia Bösmüller
Organization:
Medical University Innsbruck
Study Overview
Official Title:
Effectiveness and Safety of Campath-1H as an Induction Agent in Combination With Tacrolimus Monotherapy for Prevention of Graft Rejection Compared to Tacrolimus in Combination With MMF and Steroids in Cadaveric Kidney Transplantation
Status:
COMPLETED
Status Verified Date:
2012-06
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 purpose of this study is to determine whether Campath following Tacrolimus monotherapy is more effective in the prevention of renal graft rejection considering an acute rejection rate of 5 for Campath-1HTacrolimus and of 22 for TacrolimusMMFSteroids
Detailed Description:
Major advances in immunosuppressive therapy have resulted in long-term graft survival by the use of various drug combinationsHowever these combinations carry the risk of eg infection malignancy renal damage hypertension diabetes hyperlipidemia hirsutism cushingoid facial appearance and bone necrosisTherefore one of the major goals should be to reduce immunosuppression without increasing risk of rejections
Based on good results of a pilot study not a single acute rejection episode during the 18-20 months observation period despite low level of Tacrolimus and absence of steroids this randomised trial was designed to further evaluate the safety and efficacy of Campath-1H
Based on good results of a pilot study not a single acute rejection episode during the 18-20 months observation period despite low level of Tacrolimus and absence of steroids this randomised trial was designed to further evaluate the safety and efficacy of Campath-1H
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 |
|---|---|---|---|
| DE-02-RG-121Margreiter | None | None | None |