Practical Use of Advagraf de Novo After Kidney Transplantation According to Recipient Genetic Polymorphism
- Registration Number
- NCT02311010
- Lead Sponsor
- Université Catholique de Louvain
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 150
Inclusion Criteria
- First or second Kidney Transplantation from deceased or living donor
Exclusion Criteria
- Donor age < 5 years.
- Patients who require plasma exchange because of high immunological risk
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description CYP 3 A 5 *1/*1 Advagraf CYP 3 A 5 \*1/\*1 will receive 0,35 mg/kg of Advagraf® CYP 3 A 5 *3/*3 Advagraf CYP 3 A 5 \*3/\*3 will receive 0,25 mg/kg of Advagraf® CYP 3 A 5 *1/*3 Advagraf CYP 3 A 5 \*1/\*3 will receive 0,30 mg/kg of Advagraf®
- Primary Outcome Measures
Name Time Method Pharmacokinetics of tacrolimus 1 year tacrolimus level (ng/ml) at C0 every 3 days during 2 weeks and thereafter every month during 1 year
- Secondary Outcome Measures
Name Time Method Kidney graft function 1 year serum creatinine level (mg/dl) and GFR (ml/min)
Trial Locations
- Locations (1)
Cliniques universitaires Saint Luc Université Catholique de Louvain
🇧🇪Brussels, Belgium