Concentration Controlled Versus Fixed Dose of MMF in Kidney Transplant Recipients
Status:
Unknown status
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
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 (PRA<50%) 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 h.mg/L. 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.