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

NCT00941824 | Completed Phase 4

• 2 other identifiers: 08081002009-010710-29
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Kidney Transplantation

Keywords

pharmacokinetic; mycophénolate acid; kidney transplantation

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

mycophénolate acid DRUG

* 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 Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>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 ®

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

Departement of Nephrology CHU Saint-Etienne

Saint-Etienne, 42055, France

Location

Study Officials

• Christophe Mariat, MD PhD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 9, 2009
• First Posted: July 20, 2009
• Study Start: February 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: March 25, 2010

Record last verified: 2010-03

Locations

FR (1)