Status:
COMPLETED
AADAPT - Analysis of Advagraf Dose Adaptation Post Transplantation
Lead Sponsor:
Centre Hospitalier Universitaire de Nice
Conditions:
Renal Transplantation
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief 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 ...
Detailed Description
Multicentre open-labeled randomized pharmacokinetic (PK) and pharmacogenetic (PG) study to compare Advagraf and Prograf immediate post-transplantation (Day 8) and steady-state (Day 84) systemic exposu...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT01435291
Start Date
October 1 2011
End Date
July 1 2013
Last Update
July 29 2014
Active Locations (4)
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1
Hôpital Bicêtre
Le Kremlin-Bicêtre, France
2
CHU de Nice
Nice, France, 06200
3
CHU de Rangueil
Toulouse, France
4
CHRU Tours Hôpital Bretonneau
Tours, France