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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00941824 |
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Date of registration:
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09/07/2009 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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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
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Scientific title:
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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) |
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Date of first enrolment:
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February 2009 |
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Target sample size:
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15 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00941824 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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France
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Contacts
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Name:
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Christophe Mariat, MD PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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CHU SAINT-ETIENNE |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Kidney Transplantation
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Intervention(s)
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Drug: mycophénolate acid
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Primary Outcome(s)
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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]
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Secondary ID(s)
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2009-010710-29
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0808100
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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