Practical Use of Advagraf de Novo After Kidney Transplantation According to Recipient Genetic Polymorphism
NCT ID: NCT02311010
Last Updated: 2014-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
150 participants
INTERVENTIONAL
2011-01-31
2015-01-31
Brief Summary
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The study of the tacrolimus through level (ng/ml) determines if the therapeutic level is reached.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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CYP 3 A 5 *3/*3 control group
CYP 3 A 5 \*3/\*3 control group will receive 0,20 mg/kg of Advagraf®
No interventions assigned to this group
CYP 3 A 5 *3/*3
CYP 3 A 5 \*3/\*3 will receive 0,25 mg/kg of Advagraf®
Advagraf
daily dose adapted according to Cyp 3A5 polymorphism
CYP 3 A 5 *1/*3
CYP 3 A 5 \*1/\*3 will receive 0,30 mg/kg of Advagraf®
Advagraf
daily dose adapted according to Cyp 3A5 polymorphism
CYP 3 A 5 *1/*1
CYP 3 A 5 \*1/\*1 will receive 0,35 mg/kg of Advagraf®
Advagraf
daily dose adapted according to Cyp 3A5 polymorphism
Interventions
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Advagraf
daily dose adapted according to Cyp 3A5 polymorphism
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients who require plasma exchange because of high immunological risk
15 Years
70 Years
ALL
No
Sponsors
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Université Catholique de Louvain
OTHER
Responsible Party
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Prof Martine De Meyer
MD
Locations
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Cliniques universitaires Saint Luc Université Catholique de Louvain
Brussels, , Belgium
Countries
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References
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De Meyer M, Haufroid V, Kanaan N, Darius T, Buemi A, De Pauw L, Eddour DC, Wallemacq P, Mourad M. Pharmacogenetic-based strategy using de novo tacrolimus once daily after kidney transplantation: prospective pilot study. Pharmacogenomics. 2016 Jun;17(9):1019-27. doi: 10.2217/pgs-2016-0005. Epub 2016 Jun 8.
Other Identifiers
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2011-004276-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
BE-02-RG-234
Identifier Type: -
Identifier Source: org_study_id