Concentration Controlled Versus Fixed Dose of MMF in Kidney Transplant Recipients

Kidney Transplant Recipients Clinical Trial

Official title:

APOMYGRE : Multicenter, Randomized, Open-Label Study of MMF Therapeutic Follow-up's Interest in the the 12 First Months in Kidney Transplantation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00199667
• Other study ID #: I02013
• Status: Active, not recruiting
• Phase: Phase 4
• First received: September 14, 2005
• Last updated: December 14, 2008
• Start date: October 2002

Study information

• Verified date: December 2008
• Source: University Hospital, Limoges
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 137
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Transplant Recipients

Intervention

Drug:
• Mycophenolate Mofetil

Locations

Country	Name	City	State
France	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	Néphrologie	Tours

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Limoges	Hoffmann-La Roche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	immunosuppressant treatment fealure (kidney rejection, adverse events, death, graft lost).
Secondary	renal fonction evolution