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Completed

NCT Number: NCT01435291

AADAPT - Analysis of Advagraf Dose Adaptation Post Transplantation

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®)

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Key information

Conditions

Renal Transplantation

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hôpital Bicêtre, Le Kremlin-Bicêtre, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Advagraf Capsule

Drug

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

Prograf Capsule

Drug

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 outcomes

  1. AUC 0-24h of tacrolimus at Day 8 and Day 84

    Time frame: 3 months

Secondary outcomes

  1. AUC 24h of tacrolimus using limited samples strategies (LSS) at Day 8 and Day 84

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

Prospective Pharmacokinetic and Pharmacogenetic Analysis of Advagraf After Transplantation

Acronym: AADAPT

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Sep 16, 2011
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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