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Sponsors and Collaborators: |
Erasmus Medical Center Hoffmann-La Roche |
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Information provided by: | Erasmus Medical Center |
ClinicalTrials.gov Identifier: | NCT00166244 |
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.
Condition | Intervention | Phase |
---|---|---|
De Novo Renal Transplant Recipient. |
Drug: Mycophenolate Mofetil |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | An Open, Prospective, Randomised, Controlled, Multi-Center Study Comparing Fixed Dose Vs Concentration Controlled Mycophenolate Mofetil Regimens for De Novo Patients Following Transplantation |
Estimated Enrollment: | 900 |
Study Start Date: | May 2003 |
Estimated Study Completion Date: | April 2006 |
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.
Ages Eligible for Study: | 2 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Renal transplant recipients who have completed their second birthday,
Exclusion Criteria:
Principal Investigator: | Teun van Gelder, Dr | Erasmus Medical Center |
Study ID Numbers: | FDCC |
Study First Received: | September 9, 2005 |
Last Updated: | September 9, 2005 |
ClinicalTrials.gov Identifier: | NCT00166244 |
Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
• Mycophenolate mofetil • Therapeutic Drug Monitoring • Adult kidney transplantation • Paediatric kidney transplantation |
Mycophenolic Acid Mycophenolate mofetil |
Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Therapeutic Uses Physiological Effects of Drugs |
Enzyme Inhibitors Antibiotics, Antineoplastic Immunosuppressive Agents Pharmacologic Actions |