Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00087581
Status:
COMPLETED
Last Update Posted:
2016-11-06
First Post:
2004-07-12
Brief Title:
Study of Therapeutic Monitoring of Mycophenolate Mofetil MMFCellCept After Kidney Transplantation
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
An Open-Label Prospective Randomized Controlled Multi-Center Study Assessing Fixed Dose Versus Concentration Controlled Cellcept Regimens for Patients Following a Single Organ Renal Transplantation in Combination With Full Dose and Reduced Dose Calcineurin Inhibitors
Status:
COMPLETED
Status Verified Date:
2016-09
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:
This three-arm study will evaluate the efficacy and safety of various dosing regimens of MMF combined with various dosing regimens of calcineurin inhibitor CNI either cyclosporine or tacrolimus in participants who have undergone kidney transplantation Participants will be randomized to one of three dosing regimens to receive concentration-controlled MMF with reduced CNI concentration-controlled MMF with standard CNI or fixed-dose MMF with standard CNI Participants will be followed for 20-24 months after randomization
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