Ignite Creation Date:
2024-05-05 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00481481
Status:
COMPLETED
Last Update Posted:
2014-07-18
First Post:
2007-05-30
Brief Title:
Conversion Study From Cyclosporine to FK506MR Based Immunosuppression in Kidney Transplant Subjects
Sponsor:
Astellas Pharma Inc
Organization:
Astellas Pharma Inc
Study Overview
Official Title:
A Multicenter Single-arm Open Conversion Study From a Cyclosporine CyA Based Immunosuppressive Regimen to a Tacrolimus Modified Release FK506E MR4 Based Immunosuppressive Regimen in Kidney Transplant Subjects CONCERTO Converting Cyclosporine to FK506E MR4 in Renal Transplantation
Status:
COMPLETED
Status Verified Date:
2014-07
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:
CONCERTO
Brief Summary:
Assessment of the safety and the efficacy of a tacrolimus modified release FK506MR based immunosuppressive regimen in stable kidney transplant subjects converted from a cyclosporin based immunosuppressive regimen
Detailed Description:
Multicenter single-arm open phase IIIb conversion study where a Cyclosporine A-based immunosuppressive regimen is replaced by the administration of tacrolimus modified release formulation MR4 once daily morning dosing only in stable renal transplant subjects The initial recommended dose of MR4 is 01 mgkgday
Twenty-four weeks of treatment on MR4-based immunosuppressive regimen is considered to be an appropriate study duration in order to assess the response in subjects suffering from one or more known cyclosporine side effects hypertrichosishirsutism gingival hyperplasia hyperlipidemia arterial hypertension
Stable adult kidney transplant recipients 12 months post transplant who are currently treated with cyclosporine and who meet the Inclusion and Exclusion Criteria will be enrolled
Twenty-four weeks of treatment on MR4-based immunosuppressive regimen is considered to be an appropriate study duration in order to assess the response in subjects suffering from one or more known cyclosporine side effects hypertrichosishirsutism gingival hyperplasia hyperlipidemia arterial hypertension
Stable adult kidney transplant recipients 12 months post transplant who are currently treated with cyclosporine and who meet the Inclusion and Exclusion Criteria will be enrolled
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