Status:
UNKNOWN
Concentration Controlled Versus Fixed Dose of MMF in Kidney Transplant Recipients
Lead Sponsor:
University Hospital, Limoges
Collaborating Sponsors:
Hoffmann-La Roche
Conditions:
Kidney Transplant Recipients
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 effe...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2002
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
137 Patients enrolled
Trial Details
Trial ID
NCT00199667
Start Date
October 1 2002
Last Update
December 16 2008
Active Locations (11)
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1
Néphrologie
Amiens, France, 80000
2
Néphrologie
Angers, France, 49000
3
Néphrologie
Caen, France, 14000
4
Néphrologie
Limoges, France, 87042