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AADAPT - Analysis of Advagraf Dose Adaptation Post Transplantation

Information source: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Renal Transplantation

Intervention: Advagraf Capsule (Drug); Prograf Capsule (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Centre Hospitalier Universitaire de Nice

Official(s) and/or principal investigator(s):
Elisabeth CASSUTO, PH, Principal Investigator, Affiliation: CHU de Nice

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®)

Clinical Details

Official title: Prospective Pharmacokinetic and Pharmacogenetic Analysis of Advagraf After Transplantation

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: AUC 0-24h of tacrolimus at Day 8 and Day 84

Secondary outcome: AUC 24h of tacrolimus using limited samples strategies (LSS) at Day 8 and Day 84

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 exposure. Tacrolimus PK profile, tacrolimus systemic exposure assessed by Limited Samples Strategies (LSS) (i. e.: Bayesian estimators (BE) and Multilinear Regressions (MLR)), and impact of CYP3A5 and ABCB1 genetic polymorphisms on tacrolimus PK will also be determined to improve the optimal dose of Advagraf® for kidney transplant patients.

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

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

Locations and Contacts

Hôpital Bicêtre, Kremlin Bicêtre, France

CHU de Nice, Nice 06200, France

CHU de Rangueil, Toulouse, France

CHRU Tours Hôpital Bretonneau, Tours, France

Additional Information

Starting date: October 2011
Last updated: July 28, 2014

Page last updated: August 23, 2015

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