NCT01435291

AADAPT - Analysis of Advagraf Dose Adaptation Post Transplantation

Prospective Pharmacokinetic and Pharmacogenetic Analysis of Advagraf After Transplantation

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Centre Hospitalier Universitaire de Nice · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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®)

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.

Conditions

• Renal Transplantation

Interventions

Type	Name	Description
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
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

Timeline

• Start date: 2011-10-01
• Primary completion: 2013-05-01
• Completion: 2013-07-01
• First posted: 2011-09-16
• Last updated: 2026-03-31

Locations

4 sites across 1 country: France