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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00199667

Enrollment

137

Registered

2005-09-20

Start date

2002-10-31

Completion date

Unknown

Last updated

2008-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Transplant Recipients

Keywords

MMF, Monitoring, area under curve (AUC), kidney transplantation

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.

Interventions

DRUGMycophenolate Mofetil

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
immunosuppressant treatment fealure (kidney rejection, adverse events, death, graft lost).	—

Secondary

Measure	Time frame
renal fonction evolution	—

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026