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

Kidney Transplantation Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00941824
• Other study ID #: 0808100
• Secondary ID: 2009-010710-29
• Status: Completed
• Phase: Phase 4
• First received: July 9, 2009
• Last updated: March 24, 2010
• Start date: February 2009
• Est. completion date: March 2010

Study information

• Verified date: March 2010
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• >18 years

• Renal transplant from a dead or alive donor.

• Patients treated by initial quadritherapy with basiliximab, tacrolimus, steroid et mycophenolate sodic

• ?HCG 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.

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Transplantation

Intervention

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

Locations

Country	Name	City	State
France	Departement of Nephrology CHU Saint-Etienne	Saint-etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the curve (AUC0 - 12 hours) of the MPA and its métabolites MPAG and Ac-MPAG		at Day 2, Day 7, Day 15, Month 1, Month 3	No