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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
137
Néphrologie
Amiens, France
Néphrologie
Angers, France
Néphrologie
Caen, France
Néphrologie
Limoges, France
Néphrologie
Paris, France
Néphrologie
Poitiers, France
Néphrologie
Reims, France
Néphrologie
Rouen, France
Néphrologie
Strasbourg, France
Néphrologie
Toulouse, France
...and 1 more locations
immunosuppressant treatment fealure (kidney rejection, adverse events, death, graft lost).
renal fonction evolution
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