AADAPT - Analysis of Advagraf Dose Adaptation Post Transplantation

• Status: Completed
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: All

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®)

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Hospitalier Universitaire de Nice
• Treatments: Methylprednisolone; Mycophenolate mofetil; Mycophenolic Acid; Tacrolimus

Criteria

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 the opinion of the investigator, would not allow safe completion of the study

• Patient not able to comply with the study procedures

• Breast-feeding mother