This trial is active, not recruiting.

Condition kidney transplant recipients
Treatment mycophenolate mofetil
Phase phase 4
Sponsor University Hospital, Limoges
Collaborator Hoffmann-La Roche
Start date October 2002
Trial size 137 participants
Trial identifier NCT00199667, I02013


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment

Primary Outcomes

immunosuppressant treatment fealure (kidney rejection, adverse events, death, graft lost).
time frame:

Secondary Outcomes

renal fonction evolution
time frame:

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - patients received a first or a second kidney transplantation - patients with panel reactive antibody

Additional Information

Official title APOMYGRE : Multicenter, Randomized, Open-Label Study of MMF Therapeutic Follow-up's Interest in the the 12 First Months in Kidney Transplantation
Principal investigator Yann LE MEUR, MD
Trial information was received from ClinicalTrials.gov and was last updated in December 2008.
Information provided to ClinicalTrials.gov by University Hospital, Limoges.