Concentration Controlled Versus Fixed Dose of MMF in Kidney Transplant Recipients

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Limoges
• Collaborator: Hoffmann-La Roche
• Treatments: Mycophenolate mofetil; Mycophenolic Acid

Criteria

Inclusion Criteria:

• patients received a first or a second kidney transplantation

• patients with panel reactive antibody- 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