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

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne (Other)
• Overall Status: Completed
• CT.gov ID: NCT00941824
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Duration (Months): 12.9
• Patients Per Site Per Month: 1.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Kidney Transplantation	Drug: mycophénolate acid	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 15 participants
• Allocation: N/A
• 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)
• Study Start Date: Feb 1, 2009
• Actual Primary Completion Date: Mar 1, 2010
• Actual Study Completion Date: Mar 1, 2010

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00941824
• Other Study ID Numbers: 0808100; 2009-010710-29
• First Posted: Jul 20, 2009
• Last Update Posted: Mar 25, 2010
• Last Verified: Mar 1, 2010

• Keywords provided by , ,: pharmacokinetic; mycophénolate acid; kidney transplantation
• Additional relevant MeSH terms: Mycophenolic Acid

Study Results

No Results Posted as of Mar 25, 2010