Prospective, Randomized, Multicenter, Control Study to Assess the Efficacy and Safety of Tacrolimus in Induction and Maintenance Phase Treatment in Lupus Nephritis

Phase 3 Completed 81 enrolled Sun Yat-sen University

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to compare the efficacy and safety of tacrolimus vs intravenous cyclophosphamide pulses treatment for the induction therapy of LN(III,IV,V). To compare the efficacy and safety of tacrolimus vs Azathioprine for the maintenance therapy of LN(III,IV,V).

Timeline

Start: 2006-07
Primary completion: 2008-09
Completion: 2008-09

Publications

Chen W, Tang X, Liu Q, Chen W, Fu P, Liu F, Liao Y, Yang Z, Zhang J, Chen J, Lou T, Fu J, Kong Y, Liu Z, Fan A, Rao S, Li Z, Yu X. Short-term outcomes of induction therapy with tacrolimus versus cyclophosphamide for active lupus nephritis: A multicenter randomized clinical trial. Am J Kidney Dis. 2011 Feb;57(2):235-44. doi: 10.1053/j.ajkd.2010.08.036. Epub 2010 Dec 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Azathioprine	Small molecule	2 mg/kg	—
Comparator	Cyclophosphamide	Other / unclassified	750 mg/m2	Intravenous
Subject	Tacrolimus	Small molecule	0.05 mg/kg	—
Subject	Tacrolimus	Small molecule	0.1 mg/kg	—

Prospective, Randomized, Multicenter, Control Study to Assess the Efficacy and Safety of Tacrolimus in Induction and Maintenance Phase Treatment in Lupus Nephritis

Summary

Timeline

Publications

Drugs

Indications