NCT00615173

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 14 Years – 65 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Kidney Diseases
• Lupus Nephritis
• Tacrolimus
• Induction Phase
• Maintenance Phase

Interventions

Type	Name	Description
DRUG	tacrolimus (FK506)	Started: 0.05-0.1mg/kg/d,divided into two daily dose at 12hr; the blood level:5-10ng/ml in induction phase;and 4-6ng/ml in maintenance phase;
DRUG	cyclophosphamide or azathioprine	Induction phase: CTX 0.75g/m2 monthly Maintenance phase: AZA 2mg/kg/d.

Timeline

• Start date: 2006-07-01
• Primary completion: 2008-09-01
• Completion: 2008-09-01
• First posted: 2008-02-14
• Last updated: 2008-10-29

Locations

1 site across 1 country: China