Concentration Controlled Versus Fixed Dose of MMF in Kidney Transplant Recipients

University of Limoges (UL)

Status and phase: Unknown; Phase 4

Conditions: Kidney Transplant Recipients

Treatments: Drug: Mycophenolate Mofetil

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00199667

I02013

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)