Ignite Creation Date:
2024-05-05 @ 4:37 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00284921
Status:
TERMINATED
Last Update Posted:
2011-11-02
First Post:
2006-01-30
Brief Title:
MYPROMS-ES02 Safety and Efficacy of Basiliximab Cyclosporine Microemulsion and Enteric-coated Mycophenolate Sodium EC-MPS Versus EC-MPS and Steroid Therapy in Kidney Transplant Recipients Who Are Hepatitis C Positive
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A Twelve-month Randomized Multicenter Open-label Exploratory Study to Investigate the Clinical Outcomes of an Immunosuppressive Regimen of Basiliximab Cyclosporine Microemulsion CsA-ME and Enteric-coated Mycophenolate Sodium EC-MPS Free of Steroids Compared With a Regimen of EC-MPS With Standard Steroids in de Novo Kidney Recipients Who Are Hepatitis C Positive
Status:
TERMINATED
Status Verified Date:
2011-11
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:
To prospectively evaluate in de novo kidney transplant recipients hepatitis C positive the clinical outcomes of an immunosuppressive regimen of EC-MPS free of steroids in comparison with a regimen of EC-MPS with standard steroids as measured by the hepatic function tests ALTAST after 12 months treatment
Detailed Description:
None
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