AADAPT - Analysis of Advagraf Dose Adaptation Post Transplantation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Centre Hospitalier Universitaire de Nice.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT01435291
First received: September 15, 2011
Last updated: December 17, 2012
Last verified: August 2011
  Purpose

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®)


Condition Intervention Phase
Renal Transplantation
Drug: Advagraf Capsule
Drug: Prograf Capsule
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Pharmacokinetic and Pharmacogenetic Analysis of Advagraf After Transplantation

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nice:

Primary Outcome Measures:
  • AUC 0-24h of tacrolimus at Day 8 and Day 84 [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • AUC 24h of tacrolimus using limited samples strategies (LSS) at Day 8 and Day 84 [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 44
Study Start Date: October 2011
Estimated Study Completion Date: July 2013
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Advagraf Drug: Advagraf Capsule

Other Names:

  • FK506E
  • MR4
  • tacrolimus modified/prolonged release Drug: MPA Solution for infusion and per os Other Name: Mycophenolate Mofetil or Mycophenolic Acid Drug: Basiliximab IV infusion Other Name: Simulect Drug: Corticosteroids per os Other Name: Methylprednisolone or equivalent
Active Comparator: Prograf Drug: Prograf Capsule

Other Names:

  • FK506E
  • MR4
  • tacrolimus Drug: MPA Solution for infusion and per os Other Name: Mycophenolate Mofetil or Mycophenolic Acid Drug: Basiliximab IV infusion Other Name: Simulect Drug: Corticosteroids per os Other Name: Methylprednisolone or equivalent

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01435291

Contacts
Contact: Elisabeth CASSUTO, PH cassuto.e@chu-nice.fr
Contact: Vanina OLIVERI, ARC 0033 4 92 03 42 54 oliveri.v@chu-nice.fr

Locations
France
Hôpital Bicêtre Recruiting
Kremlin Bicêtre, France
Contact: Bernard CHARPENTIER, PU-PH    0033 1 45 21 27 70    bernard.charpentier@bct.aphp.fr   
Sub-Investigator: Bernard CHARPENTIER, PU-PH         
CHU de Nice Recruiting
Nice, France, 06200
Contact: Elisabeth CASSUTO, PH         
Principal Investigator: Elisabeth CASSUTO         
CHU de Rangueil Recruiting
Toulouse, France
Contact: Lionel ROSTAING, PU-PH    05 61 32 25 84    rostaing.l@chu-toulouse.fr   
Sub-Investigator: Lionel ROSTAING, PU-PH         
CHRU Tours Hôpital Bretonneau Recruiting
Tours, France
Contact: Yvon LEBRANCHU, PU-PH    0033 2 47 47 82 29    lebranchu@med.univ-tours.fr   
Sub-Investigator: Matthias BUCHLER, PU-PH         
Sub-Investigator: Yvon LEBRANCHU, PU-PH         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Investigators
Principal Investigator: Elisabeth CASSUTO, PH CHU de Nice
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT01435291     History of Changes
Other Study ID Numbers: 11-PP-07
Study First Received: September 15, 2011
Last Updated: December 17, 2012
Health Authority: France: Committee for the Protection of Personnes
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014