Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2025-12-25 @ 6:09 PM
Study NCT ID:
NCT00737659
Status:
UNKNOWN
Last Update Posted:
2010-03-26
First Post:
2008-08-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CellCept® Dose Adjustment Versus Fixed Dose (Standard Care) in Renal Transplant Recipients
Sponsor:
Rabin Medical Center
Organization:
Study Overview
Official Title:
Phase IV, Open-Label, Multicenter, Randomized Study Comparing Mycophenolate Mofetil (MMF) Dose Adjustment Based on Blood MPA Concentration to Standard Care Treatment With MMF in Renal Transplant Recipients Receiving Tacrolimus
Status:
UNKNOWN
Status Verified Date:
2008-12
Last Known Status:
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:
MMF
Brief Summary:
In order to avoid renal transplant rejection, the immune system should be suppressed. After the renal transplant subjects are treated with a combination of two to four different types of immunosuppressive drugs. Theses drugs are very efficient in the prevention of the renal transplant rejection. Still, they can cause side effect.
Research in renal transplant tries to find the best treatment in order to avoid renal rejection on one hand and to reduce as much as possible the undesired adverse and toxicity effects on the other hand.
Therapeutic efficacy and the onset of adverse effects are influenced by levels of mycophenolic acid (MPA, the active metabolite of MMF, CellCept®).
The primary objective of this study is to assess the treatment superiority of CellCept® Dose Adjustment treatment, based on individual MPA concentration value monitored periodically, against treatment with CellCept® Fixed Dose (standard care).
Research in renal transplant tries to find the best treatment in order to avoid renal rejection on one hand and to reduce as much as possible the undesired adverse and toxicity effects on the other hand.
Therapeutic efficacy and the onset of adverse effects are influenced by levels of mycophenolic acid (MPA, the active metabolite of MMF, CellCept®).
The primary objective of this study is to assess the treatment superiority of CellCept® Dose Adjustment treatment, based on individual MPA concentration value monitored periodically, against treatment with CellCept® Fixed Dose (standard care).
Detailed Description:
Patient will be randomized into two treatment groups on a 1:1 ratio. Both groups will be treated with the same drugs which is the usual treatment for avoiding renal transplant rejection. In one group the CellCept® dose will be adjusted based on MPA concentration value which will be monitored periodically; and the second group will be treated with CellCept® Fixed Dose (based on the clinical judgment of the treating physician).
Study Oversight
Has Oversight DMC:
False
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?: