Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00282568
Status:
COMPLETED
Last Update Posted:
2013-09-26
First Post:
2006-01-25
Brief Title:
A Study to Assess the Pharmacokinetics of a Modified-release Tacrolimus Based Immunosuppression Regimen in Stable Kidney Transplant Patients
Sponsor:
Astellas Pharma Inc
Organization:
Astellas Pharma Inc
Study Overview
Official Title:
A Phase 2 Open-Label Multi-center Study to Assess the Pharmacokinetics Safety and Tolerability of Tacrolimus in Stable Kidney Transplant Patients Converted From a Prograf Based Immunosuppression Regimen to a Modified Release MR Tacrolimus Based Immunosuppression Regimen
Status:
COMPLETED
Status Verified Date:
2013-07
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:
None
Brief Summary:
A study to assess the pharmacokinetics safety and effectiveness of tacrolimus in stable kidney transplant patients converted from a Prograf based immunosuppression regimen to a modified release tacrolimus based immunosuppression regimen
Detailed Description:
This is a Phase II open-label multi-center conversion study in stable adult kidney transplant recipients to assess the pharmacokinetics safety and effectiveness of tacrolimus in stable kidney transplant patients converted from a Prograf based immunosuppression regimen to a modified release tacrolimus based immunosuppression regimen
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