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:
Information provided by:
Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:
NCT00941824
First received: July 9, 2009
Last updated: March 24, 2010
Last verified: March 2010
  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: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Clément Caillaux,, CHU SAINT-ETIENNE
ClinicalTrials.gov Identifier: NCT00941824     History of Changes
Other Study ID Numbers: 0808100, 2009-010710-29
Study First Received: July 9, 2009
Last Updated: March 24, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

Additional relevant MeSH terms:
Mycophenolic Acid
Mycophenolate mofetil
Tacrolimus
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014