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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
  Purpose

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.


Condition Intervention Phase
Kidney Transplantation Drug: mycophénolate acid Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Saint Etienne:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 15
Study Start Date: February 2009
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00941824


Locations
France
Departement of Nephrology CHU Saint-Etienne
Saint-etienne, France, 42055
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Investigators
Principal Investigator: Christophe Mariat, MD PhD CHU SAINT-ETIENNE
  More Information

Responsible Party: Clément Caillaux,, CHU SAINT-ETIENNE
ClinicalTrials.gov Identifier: NCT00941824     History of Changes
Other Study ID Numbers: 0808100
2009-010710-29
First Submitted: July 9, 2009
First Posted: July 20, 2009
Last Update Posted: March 25, 2010
Last Verified: March 2010

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
pharmacokinetic
mycophénolate acid
kidney transplantation

Additional relevant MeSH terms:
Tacrolimus
Mycophenolic Acid
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents