Clinical trial NCT00199667: Concentration Controlled Versus Fixed Dose of MMF in Kidney Transplant Recipients
Official title: APOMYGRE : Multicenter, Randomized, Open-Label Study of MMF Therapeutic Follow-up's Interest in the the 12 First Months in Kidney Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Kidney Transplant Recipients
Keywords: MMF, Monitoring, area under curve (AUC), kidney transplantation
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
Collaborators: name: Hoffmann-La Roche
First posted: 2005-09-20
Enrollment: 137
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: immunosuppressant treatment fealure (kidney rejection, adverse events, death, graft lost).
Secondary outcomes:
measure: renal fonction evolution
Other outcomes:
Locations:
city: Amiens
country: France
facility: Néphrologie
city: Angers
country: France
facility: Néphrologie
city: Caen
country: France
facility: Néphrologie
city: Limoges
country: France
facility: Néphrologie
city: Paris
country: France
facility: Néphrologie
city: Poitiers
country: France
facility: Néphrologie
city: Reims
country: France
facility: Néphrologie
city: Rouen
country: France
facility: Néphrologie
city: Strasbourg
country: France
facility: Néphrologie
city: Toulouse
country: France
facility: Néphrologie
city: Tours
country: France
facility: Néphrologie
Study officials:
affiliation: University Hospital, Limoges
name: Yann LE MEUR, MD
role: PRINCIPAL_INVESTIGATOR
References: