Comparative Study of Modified Release (MR) Tacrolimus/Mycophenolate Mofetil (MMF) in de Novo Kidney Transplant Recipients

Phase 3 Completed 668 enrolled Astellas Pharma Inc

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to compare the safety and efficacy of tacrolimus/mycophenolate mofetil (MMF), cyclosporine/MMF and tacrolimus modified release/MMF in de novo kidney transplant recipients.

Timeline

Start: 2003-06
Primary completion: 2005-03
Completion: 2009-03

Publications

Background Silva HT Jr, Yang HC, Abouljoud M, Kuo PC, Wisemandle K, Bhattacharya P, Dhadda S, Holman J, Fitzsimmons W, First MR. One-year results with extended-release tacrolimus/MMF, tacrolimus/MMF and cyclosporine/MMF in de novo kidney transplant recipients. Am J Transplant. 2007 Mar;7(3):595-608. doi: 10.1111/j.1600-6143.2007.01661.x. Epub 2007 Jan 11.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Cyclosporine	Peptide	4 mg/kg	Oral
Comparator	Cyclosporine	Peptide	5 mg/kg	Oral
Subject	Tacrolimus	Small molecule	0.075 mg/kg	Oral
Subject	Tacrolimus	Small molecule	0.1 mg/kg	Oral
Subject	Tacrolimus	Small molecule	0.15 mg/kg	Oral
Subject	Tacrolimus	Small molecule	0.2 mg/kg	Oral
Background	Mycophenolate Mofetil	Small molecule	1 g	Oral

Indications

No indication recorded.