Mycophenolate Mofetil (MMF) Discontinuation From a Tacrolimus/MMF/Steroid Triple Regimen After Kidney Transplantation

Phase 3 Completed 152 enrolled Astellas Pharma Inc

RandomizedParallel-groupOpen-labelTreatment

Summary

Patients after kidney transplantation received immunosuppression by Tacrolimus, MMF and steroids. In one half of the patients after 7 weeks MMF was reduced by half, and after 12 weeks it was stopped. For the others MMF remained at initial dose.

Timeline

Start: 2003-02
Primary completion: 2004-08
Completion: 2004-08

Publications

Background Sulowicz W, Bachleda P, Rydzewski A, Rutkowski B, Szakaly P, Asztalos L, Samlik J, Lackova E, Ksiazek A, Studenik P, Mysliwiec M, Hruby Z, Navratil P, Gumprecht J. Discontinuation of mycophenolate mofetil from a tacrolimus-based triple regimen 2 months after renal transplantation: a comparative randomized, multicentre study. Transpl Int. 2007 Mar;20(3):230-7. doi: 10.1111/j.1432-2277.2006.00421.x.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Mycophenolate Mofetil	Small molecule	—	Oral
Background	Methylprednisolone	Other / unclassified	—	Intravenous
Background	Prednisone	Other / unclassified	—	Intravenous
Background	Tacrolimus	Small molecule	—	Oral

Indications

No indication recorded.