Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00177138
Status:
TERMINATED
Last Update Posted:
2013-02-07
First Post:
2005-09-13
Brief Title:
Use of Campath for Induction and Maintenance Therapy in Pancreas After Kidney Transplantation
Sponsor:
University of Minnesota
Organization:
University of Minnesota
Study Overview
Official Title:
Use of Campath for Induction and Maintenance Therapy in Pancreas After Kidney Transplantation
Status:
TERMINATED
Status Verified Date:
2013-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The clinical use of Campath for transplant patients was temporarily suspended
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a single center prospective open-label randomized trial at the University of Minnesota Medical CenterFairview
Primary objectives are to determine if rejection episodes and loss rates graft survival level of renal graft function and patient survival rates with a CampathMMF-based Group 1 immunosuppressive protocol are lower than or equal to our protocol using thymoglobulin tacrolimus and MMF Group 2
This study will investigate the first protocol that is both steroid-free and calcineurin inhibitor-free in pancreas after kidney transplant recipients
Primary objectives are to determine if rejection episodes and loss rates graft survival level of renal graft function and patient survival rates with a CampathMMF-based Group 1 immunosuppressive protocol are lower than or equal to our protocol using thymoglobulin tacrolimus and MMF Group 2
This study will investigate the first protocol that is both steroid-free and calcineurin inhibitor-free in pancreas after kidney transplant recipients
Detailed Description:
Secondary objectives of the study are
1 Compare the side effects of the immunosuppressive medications between both groups This will include anaphylactic reactions GI side-effects bone marrow suppression renal dysfunction hypertension hyperglycemic effects and effects on lipid profile
2 Compare the incidence of infections between both groups
Comparison parameters are
1 Pancreas and kidney graft failure
2 Patient death
3 Clinical and biopsy documented rejection episodes
4 Patient dropout non-compliance with the study protocol
5 Kidney function as assessed by creatinine clearance or biopsy
6 Need to change immunosuppression regimen
7 Quality-adjusted Life Years
1 Compare the side effects of the immunosuppressive medications between both groups This will include anaphylactic reactions GI side-effects bone marrow suppression renal dysfunction hypertension hyperglycemic effects and effects on lipid profile
2 Compare the incidence of infections between both groups
Comparison parameters are
1 Pancreas and kidney graft failure
2 Patient death
3 Clinical and biopsy documented rejection episodes
4 Patient dropout non-compliance with the study protocol
5 Kidney function as assessed by creatinine clearance or biopsy
6 Need to change immunosuppression regimen
7 Quality-adjusted Life Years
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 |
|---|---|---|---|
| Berlex Study No 107G0001 | None | None | None |