Ignite Creation Date:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2026-01-03 @ 9:16 PM
Study NCT ID:
NCT00596557
Status:
COMPLETED
Last Update Posted:
2011-07-29
First Post:
2008-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Everolimus and Low Dose CNI Compared With MMF and Full CNI Dose in Heart Transplanted Patients: One Year Follow up
Sponsor:
Rabin Medical Center
Organization:
Study Overview
Official Title:
Phase IV: Effect of Everolimus and CNI Minimalization on Renal Function.
Status:
COMPLETED
Status Verified Date:
2011-07
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:
CRAD001AILO2
Brief Summary:
The different mechanisms of action of Everolimus and cyclosporine suppress immune function in synergistic manner. Thus it is postulated that the use of Everolimus in combination with cyclosporine permits a significant cyclosporine dose reduction without loss of immunosuppressive activity in the clinical setting.
The aim of the present study is to evaluate the evolution of renal function after initiation of Everolimus and minimalisation of CNI dose.
The aim of the present study is to evaluate the evolution of renal function after initiation of Everolimus and minimalisation of CNI dose.
Detailed Description:
Everolimus is a new proliferation signal inhibitor with immunosuppressive and antiproliferative activity.
The mechanism of action of Everolimus is distinct from that of calcineurin inhibitors.
Cardiac allograft vasculopathy is the major cause of late death in cardiac transplant patients.
The different mechanisms of action of Everolimus and cyclosporine suppress immune function in synergistic manner. Thus it is postulated that the use of Everolimus in combination with cyclosporine permits a significant cyclosporine dose reduction without loss of immunosuppressive activity in the clinical setting.
The aim of the present study is to evaluate the evolution of renal function after initiation of Everolimus and minimalisation of CNI dose.
The mechanism of action of Everolimus is distinct from that of calcineurin inhibitors.
Cardiac allograft vasculopathy is the major cause of late death in cardiac transplant patients.
The different mechanisms of action of Everolimus and cyclosporine suppress immune function in synergistic manner. Thus it is postulated that the use of Everolimus in combination with cyclosporine permits a significant cyclosporine dose reduction without loss of immunosuppressive activity in the clinical setting.
The aim of the present study is to evaluate the evolution of renal function after initiation of Everolimus and minimalisation of CNI dose.
Study Oversight
Has Oversight DMC:
False
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?: