Concentration Controlled Versus Fixed Dose of MMF in Kidney Transplant Recipients

APOMYGRE : Multicenter, Randomized, Open-Label Study of MMF Therapeutic Follow-up's Interest in the the 12 First Months in Kidney Transplantation

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.

Inclusion Criteria:

• patients received a first or a second kidney transplantation
• patients with panel reactive antibody <or= 50 %
• patients with cellcept treatment since fewer 3 days
• patients receiving or being received ciclosporine treatment
• patients without retention, important hepatic cytolysis
• patients without post-surgical complication or intercurrent disease
• informed consent signed

Exclusion Criteria:

• patients included in other study
• patients with MMF or mycophenolic acid hypersensibility or MMF contraindication
• patients with gastroduodenal disorder before the beginning of the study
• pregnant women or without contraception
• patients with rapamycin or analogous
• patients with toxicomania or psychiatric disorder