AADAPT - Analysis of Advagraf Dose Adaptation Post Transplantation (NCT01435291) | Clinical Trial Compass
CompletedPhase 4
AADAPT - Analysis of Advagraf Dose Adaptation Post Transplantation
France45 participantsStarted 2011-10
Plain-language summary
A pharmacokinetics and pharmacogenetics study to complement the current knowledge of tacrolimus prolonged release (Advagraf®) in the immediate post-transplantation period and at steady-state (M3 post transplantation) and to improve the optimal dose of Advagraf® based on tacrolimus AUC estimated by two Limited Samples Strategies during the first 3 months after renal transplantation.
Data obtained with tacrolimus prolonged release will be compared with those of tacrolimus immediate release (Prograf®)
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion Criteria:
* Adult recipients aged between 18 to 70
* Primary renal transplantation
* Cadaver or living transplantation or living (non HLA identical) donor with compatible ABO blood type.
* absence of anti-LHA antibodies in lymphocytotoxicity and Luminex
* Negative cross-match in cytotoxicity
* Negative pregnancy test for female patients of childbearing potential, and agreement to practice effective birth control during the study
Exclusion Criteria:
* Combined transplantation
* Renal bigraft
* History of any other transplantation
* Receiving a graft from a non-heart-beating donor.
* Requiring ongoing dosing with a systemic immunosuppressive drug prior to transplantation
* Patient who received within one month prior to study an inductor of CYP50 3A or requiring during the study an inhibitor of CYP50 3A or of P-gp.
* Significant, uncontrolled concomitant infections and/or severe diarrhoea, vomiting, active upper gastro-intestinal tract malabsorption or active peptic ulcer
* Subject or donor known to be HIV positive
* Active viral hepatitis (VHB, VHC) at randomisation
* Known allergy or intolerance to tacrolimus, macrolide antibiotics, corticosteroids, or mycophenolate mofetil or any of the product excipients
* Diagnosis of new-onset malignancy prior to transplantation, with the exception of basocellular or squamous cell carcinoma of the skin which had been treated successfully.
* Current participation in any other clinical study
* Any clinical condition which, in th…