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AADAPT - Analysis of Advagraf Dose Adaptation Post Transplantation (AADAPT)

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ClinicalTrials.gov Identifier: NCT01435291
Recruitment Status : Completed
First Posted : September 16, 2011
Last Update Posted : July 29, 2014
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice

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 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 or disease Intervention/treatment Phase
Renal Transplantation Drug: Advagraf Capsule Drug: Prograf Capsule Phase 4

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Pharmacokinetic and Pharmacogenetic Analysis of Advagraf After Transplantation
Study Start Date : October 2011
Actual Primary Completion Date : May 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Tacrolimus
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. AUC 0-24h of tacrolimus at Day 8 and Day 84 [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. AUC 24h of tacrolimus using limited samples strategies (LSS) at Day 8 and Day 84 [ Time Frame: 3 months ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01435291


Locations
France
Hôpital Bicêtre
Kremlin Bicêtre, France
CHU de Nice
Nice, France, 06200
CHU de Rangueil
Toulouse, France
CHRU Tours Hôpital Bretonneau
Tours, France
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Investigators
Principal Investigator: Elisabeth CASSUTO, PH CHU de Nice

Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT01435291     History of Changes
Other Study ID Numbers: 11-PP-07
First Posted: September 16, 2011    Key Record Dates
Last Update Posted: July 29, 2014
Last Verified: August 2011

Additional relevant MeSH terms:
Mycophenolic Acid
Tacrolimus
Methylprednisolone
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Immunosuppressive Agents
Immunologic Factors
Calcineurin Inhibitors