Calcineurin Free Immunosuppression in Renal Transplant Recipients

Phase 4 Completed 127 enrolled University Hospital, Basel, Switzerland Wyeth is now a wholly owned subsidiary of Pfizer · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

The main purpose of this study is to obtain preliminary information on the efficacy, safety and cost of two regimens, Rapamycin / MMF / steroid therapy and Cyclosporine A Neoral / MMF / steroid therapy, used in the prevention of acute rejection following renal transplantation.

Timeline

Start: 2001-01
Primary completion: 2005-07
Completion: 2005-07

Publications

Franz S, Regeniter A, Hopfer H, Mihatsch M, Dickenmann M. Tubular toxicity in sirolimus- and cyclosporine-based transplant immunosuppression strategies: an ancillary study from a randomized controlled trial. Am J Kidney Dis. 2010 Feb;55(2):335-43. doi: 10.1053/j.ajkd.2009.09.004. Epub 2009 Nov 17.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Cyclosporine	Peptide	300 mg	—
Subject	Sirolimus	Small molecule	30 mg	—
Background	Mycophenolate Mofetil	Small molecule	1000 mg	—
Background	Prednisone	Other / unclassified	0.1 mg/kg	—

Calcineurin Free Immunosuppression in Renal Transplant Recipients

Summary

Timeline

Publications

Drugs

Indications