NCT00199667

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 137 (planned)
• Sponsor: University Hospital, Limoges · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Kidney Transplant Recipients

Interventions

Type	Name	Description
DRUG	Mycophenolate Mofetil

Timeline

• Start date: 2002-10-01
• First posted: 2005-09-20
• Last updated: 2008-12-16

Locations

11 sites across 1 country: France