NCT00166244

Fixed Dose MMF vs Concentration Controlled MMF After Renal Transplantation

An Open, Prospective, Randomised, Controlled, Multi-Center Study Comparing Fixed Dose vs Concentration Controlled Mycophenolate Mofetil Regimens for de Novo Patients Following Transplantation

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 901 (actual)
• Sponsor: Erasmus Medical Center · Academic / Other
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

Summary

Determine the value of a clinically feasible strategy of therapeutic drug monitoring compared with fixed dosing in de novo MMF treated renal transplant recipients with respect to the incidence of treatment failure.

Detailed description

For treatment with mycophenolate mofetil the contribution of TDM still has to be determined, although circumstantial evidence suggests the measurement of mycophenolic acid plasma concentrations adds to patient management. A concerted effort to test the hypothesis that TDM will improve outcome in mycophenolate mofetil therapy in a prospective randomised trial is to be made if we want to have a solid base for the continued measurements of mycophenolic acid concentrations in the future. This trial aims to demonstrate the added value of TDM for mycophenolic acid, by comparing fixed dose treatment with concentration controlled mycophenolate mofetil treatment in kidney transplant recipients.

Conditions

• De Novo Renal Transplant Recipient.

Interventions

Type	Name	Description
DRUG	Mycophenolate Mofetil	1 g for adult patients and 300 mg/m2 for paediatric patients. Fixed dose arm: 1 g twice a day (bid) for adults and 600mg/m2 bid for paediatric patients. Concentration controlled arm: initial dose will be 1 g bid for adults and 600mg/m2 bid for paediatric patients. Abbreviated AUCs (taken at timepoints: 0, 30min and 120min in fasted patients) on Days 3 and 10, Week 4, Months 3, 6 and 12 will be performed to determine mycophenolic acid levels in plasma.

Timeline

• Start date: 2003-05-01
• Primary completion: 2005-03-01
• Completion: 2006-04-01
• First posted: 2005-09-14
• Last updated: 2009-02-12

Locations

67 sites across 19 countries: Australia, Austria, Belgium, Brazil, Canada, China, Denmark, Estonia, France, Germany, Lithuania, Netherlands, Norway, Poland, Spain, Sweden, Taiwan, United Kingdom, Venezuela