NCT00298506

Study to Assess the Efficacy and Safety of FK506 Combined With Mycophenolate Mofetil (MMF) in Lupus Nephritis (III/IV/V)

An Open, Prospective Study to Assess the Efficacy and Safety of FK506 Combined MMF in the Treatment of Class III，IV，V + IV or V + III Lupus Nephritis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Nanjing University School of Medicine · Academic / Other
• Sex: Female
• Age: 12 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This is an open, prospective study to assess the efficacy and safety of Tacrolimus (FK506) combined with MMF in the treatment of class III, IV, V + IV or V + III lupus nephritis.

Detailed description

1. To assess the efficacy of FK506 combined with MMF vs intravenous CTX pulses in treatment of class Ⅲ, Ⅳ, Ⅴ + Ⅳ or Ⅴ + Ⅲ LN. 2. To investigate the safety and tolerability of FK506 combined with MMF vs intravenous CTX pulses in the treatment of class Ⅲ, Ⅳ, Ⅴ + Ⅳ or Ⅴ + Ⅲ LN. 3. To explore the dosing of FK506 combined with MMF and their effective range of blood concentration.

Conditions

• Lupus Nephritis

Interventions

Type	Name	Description
DRUG	Multitherapy	Tacrolimus,4mg/d, MMF 1.0g/d

Timeline

• Start date: 2005-09-01
• Primary completion: 2008-12-01
• Completion: 2009-06-01
• First posted: 2006-03-02
• Last updated: 2011-09-29

Locations

2 sites across 1 country: China