CellCept® Dose Adjustment Versus Fixed Dose (Standard Care) in Renal Transplant Recipients
Status:
Unknown status
Trial end date:
2013-08-01
Target enrollment:
Participant gender:
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).