Practical Use of Advagraf de Novo After Kidney Transplantation According to Recipient Genetic Polymorphism

Université Catholique de Louvain150 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

150

Conditions

Kidney Diseases

Interventions

AdvagrafDRUG

daily dose adapted according to Cyp 3A5 polymorphism

Eligibility

Sex: ALLMin age: 15 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Cliniques universitaires Saint Luc Université Catholique de Louvain

Brussels, Belgium

Outcomes

Primary Outcomes

Pharmacokinetics of tacrolimus

tacrolimus level (ng/ml) at C0 every 3 days during 2 weeks and thereafter every month during 1 year

Time frame: 1 year

Secondary Outcomes

Kidney graft function

serum creatinine level (mg/dl) and GFR (ml/min)

Time frame: 1 year

Data from ClinicalTrials.gov

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