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Fixed Dose MMF vs Concentration Controlled MMF After Renal Transplantation

NCT00166244 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 901

Last updated 2009-02-12

No results posted yet for this study

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.

Conditions

  • De Novo Renal Transplant Recipient.

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Teun van Gelder, Dr · Erasmus Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-05-31
Primary Completion
2005-03-31
Completion
2006-04-30

Countries

  • Australia
  • Austria
  • Belgium
  • Brazil
  • Canada
  • China
  • Denmark
  • Estonia
  • France
  • Germany
  • Lithuania
  • Netherlands
  • Norway
  • Poland
  • Spain
  • Sweden
  • Taiwan
  • United Kingdom
  • Venezuela

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00166244 on ClinicalTrials.gov