AADAPT - Analysis of Advagraf Dose Adaptation Post Transplantation

Phase 4 Completed 45 enrolled Centre Hospitalier Universitaire de Nice

RandomizedParallel-groupOpen-labelTreatment

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®)

Timeline

Start: 2011-10
Primary completion: 2013-05
Completion: 2013-07

Publications

Results Kramer BK, Albano L, Banas B, Charpentier B, Backman L, Tedesco-Silva H Jr, Lehner F, Mondragon-Ramirez GA, Glyda M, Cassuto-Viguier E, Viklicky O, Mourad G, Rigotti P, Schleibner S, Kamar N. Efficacy of Prolonged- and Immediate-release Tacrolimus in Kidney Transplantation: A Pooled Analysis of Two Large, Randomized, Controlled Trials. Transplant Proc. 2017 Nov;49(9):2040-2049. doi: 10.1016/j.transproceed.2017.07.011.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tacrolimus	Small molecule	—	—
Background	Basiliximab	Monoclonal antibody	—	Intravenous
Background	Methylprednisolone	Other / unclassified	—	Oral
Background	Mycophenolate Mofetil	Small molecule	—	Intravenous
Background	mycophenolic acid	Small molecule	—	Intravenous

Indications

No indication recorded.