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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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
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
Start Date
October 1, 2002
Last Updated
December 16, 2008
137
Estimated participants
Mycophenolate Mofetil
DRUG
Lead Sponsor
University Hospital, Limoges
Collaborators
NCT05702398
NCT04965935
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