Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00199667
Status:
UNKNOWN
Last Update Posted:
2008-12-16
First Post:
2005-09-14
Brief Title:
Concentration Controlled Versus Fixed Dose of MMF in Kidney Transplant Recipients
Sponsor:
University Hospital Limoges
Organization:
University Hospital Limoges
Study Overview
Official Title:
APOMYGRE Multicenter Randomized Open-Label Study of MMF Therapeutic Follow-ups Interest in the the 12 First Months in Kidney Transplantation
Status:
UNKNOWN
Status Verified Date:
2008-12
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
Acumulating data suggest that thrapeutic drug therapeutic may optimize efficacity and tolerance of MMF It could guarantee better exposure to the drug in the first 3 months and then minimize side effects in the long term However definitive proof is still lacking We conducted a randomized study in 11 french centers and included 137 kidney transplant recipients PRA50 receiving a classical immunosuppressant regimen with basiliximab Csa MMF and steroids The fixed dose group received 2 g of MMF a day The concentration controlled group received MMF dose adapted to the area under the concentration curve AUC of MPA with a target of 40 hmgL After transplantation AUCs were calculated with a Bayesian estimator using a 3-point limited sampling strategy on day 7 14 and months 1 3 6 12 in both groups values note communicated to the physicians in the fixed dose group
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