Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00359658
Status:
COMPLETED
Last Update Posted:
2009-02-13
First Post:
2006-08-01
Brief Title:
Withdrawal of Steroids Cyclosporine A Dose Reduction and Switch to Mycophenolatmofetile After Heart Transplantation
Sponsor:
Hannover Medical School
Organization:
Hannover Medical School
Study Overview
Official Title:
Conversion Study to Optimize Immunosuppressive Regimen by Withdrawal of Steroids Cyclosporine A Dose Reduction and a Switch to Mycophenolatmofetile for Patients After Heart Transplantation in the Long-Term
Status:
COMPLETED
Status Verified Date:
2009-02
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 first to improve or save renal function and second to decrease cardiac risk factors by optimising the immunosuppressive regimen by withdrawing steroids and reducing the Cyclosporine A dose The concomitant administration of Mycophenolatmofetile an effective immunosuppressive agent will minimize the risk of acute rejection episodes
Detailed Description:
The decrease of quality of life in patients after heart transplantation in the long-term is determined by an increasing incidence of transplant vasculopathy and by immunosuppression-related side effects Calcineurin inhibitors are associated with chronic nephrotoxicity while long-term administration of steroids results in an increased incidence of cardiovascular risk factors eg hypertension lipometabolic disorders steroid induced diabetes adipositasand therefore carries the potential of graft disfunction
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