Practical Use of Advagraf de Novo After Kidney Transplantation According to Recipient Genetic Polymorphism
CYRANO
Influence of Recipient Cytochrome P450 3A5 Polymorphism on the Metabolism of Prolonged Release Tacrolimus Administered de Novo After Renal Transplantation
2 other identifiers
interventional
150
1 country
1
Brief Summary
To optimize the Advagraf (tacrolimus once a day) initial daily dose used in de novo after kidney transplantation in combination with MMF (or MPA) and corticosteroids (CS) regarding of the genetic Cyp 450 3A5 polymorphism of the recipient. The study of the tacrolimus through level (ng/ml) determines if the therapeutic level is reached.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jan 2011
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 21, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedFirst Posted
Study publicly available on registry
December 8, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedDecember 8, 2014
December 1, 2014
3.8 years
August 21, 2014
December 4, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pharmacokinetics of tacrolimus
tacrolimus level (ng/ml) at C0 every 3 days during 2 weeks and thereafter every month during 1 year
1 year
Secondary Outcomes (1)
Kidney graft function
1 year
Other Outcomes (2)
Administration strategy
first day
New onset of diabetes after transplantation (NODAT)
1 year
Study Arms (4)
CYP 3 A 5 *3/*3 control group
NO INTERVENTIONCYP 3 A 5 \*3/\*3 control group will receive 0,20 mg/kg of Advagraf®
CYP 3 A 5 *3/*3
ACTIVE COMPARATORCYP 3 A 5 \*3/\*3 will receive 0,25 mg/kg of Advagraf®
CYP 3 A 5 *1/*3
ACTIVE COMPARATORCYP 3 A 5 \*1/\*3 will receive 0,30 mg/kg of Advagraf®
CYP 3 A 5 *1/*1
ACTIVE COMPARATORCYP 3 A 5 \*1/\*1 will receive 0,35 mg/kg of Advagraf®
Interventions
daily dose adapted according to Cyp 3A5 polymorphism
Eligibility Criteria
You may qualify if:
- First or second Kidney Transplantation from deceased or living donor
You may not qualify if:
- Donor age \< 5 years.
- Patients who require plasma exchange because of high immunological risk
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cliniques universitaires Saint Luc Université Catholique de Louvain
Brussels, 1200, Belgium
Related Publications (1)
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.
PMID: 27266721DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
August 21, 2014
First Posted
December 8, 2014
Study Start
January 1, 2011
Primary Completion
October 1, 2014
Study Completion
January 1, 2015
Last Updated
December 8, 2014
Record last verified: 2014-12