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Pharmacokinetic Evaluation of an Intensified and Decreasing Dosing Regimen of Mycophenolate Sodium in Combination With Tacrolimus Post Kidney Transplant: The Myfortic Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00941824
First Posted: July 20, 2009
Last Update Posted: March 25, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Centre Hospitalier Universitaire de Saint Etienne
July 9, 2009
July 20, 2009
March 25, 2010
February 2009
March 2010   (Final data collection date for primary outcome measure)
Area under the curve (AUC0 - 12 hours) of the MPA and its métabolites MPAG and Ac-MPAG [ Time Frame: at Day 2, Day 7, Day 15, Month 1, Month 3 ]
Same as current
Complete list of historical versions of study NCT00941824 on ClinicalTrials.gov Archive Site
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Pharmacokinetic Evaluation of an Intensified and Decreasing Dosing Regimen of Mycophenolate Sodium in Combination With Tacrolimus Post Kidney Transplant: The Myfortic Study
Pharmacokinetic Evaluation of an Intensified and Decreasing Dosing Regimen of Mycophenolate Sodium in Combination With Tacrolimus During the First 3 Months Post Kidney Transplant (the myFORTic Study)

Mycophenolate acid (MPA) has been developed and approved in combination with cyclosporine and has been used in kidney transplantation for more than a decade. At present, combination of tacrolimus and mycophenolate acid tends to be considered as the standard of care for maintenance immunosuppression in kidney transplantation. Mainly due to a different effect on the entero-hepatic recycling pathway, cyclosporine and tacrolimus differently interfere with MPA clearance. When used with tacrolimus, MPA dosage has thus to be adjusted and cannot be extrapolated from what is recommended for a cyclosporine-based treatment. However, there is currently no clear guideline for MPA dosing when this drug is used in combination with tacrolimus. This is potentially detrimental for patients since under-or overexposure of MPA has been clinically linked to the outcome of transplantation.

The purpose of this study is to pharmacologically validate an original MPA dosing regimen in combination with tacrolimus within the three months post-kidney transplant. This regimen consists in an intensified dosing of mycophenolate sodium during the earliest period of transplantation in order to rapidly reach the appropriate MPA blood exposure followed by a gradual decrease in dose in order to prevent MPA overexposure.

Not Provided
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Kidney Transplantation
Drug: mycophénolate acid
  • Day 0 to Day 7, 720 mg twice daily
  • Day 8 to Day 30, 540 mg twice daily
  • Day 30 to Day 90, 360 mg twice daily
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Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
March 2010
March 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • >18 years
  • Renal transplant from a dead or alive donor.
  • Patients treated by initial quadritherapy with basiliximab, tacrolimus, steroid et mycophenolate sodic
  • ΒHCG pregnancy test negative at the initiation of Myfortic ®
  • Effective contraception during treatment and up to 6 weeks after treatment with Myfortic ®

Exclusion Criteria:

  • Patient at high risk of rejection of a transplant
  • IMC > ou = 30
  • Platelets < 75000 / mm3 and/or neutrophils < 1500 / mm3 and/or leukocytes < 2500/ mm3 and/or hemoglobin < 6 g/dL.
  • Patient requiring a anti-CMV prophylaxis by valganciclovir.
  • Pregnancy or breast feeding.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT00941824
0808100
2009-010710-29
No
Not Provided
Not Provided
Clément Caillaux,, CHU SAINT-ETIENNE
Centre Hospitalier Universitaire de Saint Etienne
Not Provided
Principal Investigator: Christophe Mariat, MD PhD CHU SAINT-ETIENNE
Centre Hospitalier Universitaire de Saint Etienne
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP