Clinical Trial: Study to Assess the Efficacy and Safety of FK506 Combined With Mycophenolate Mofetil (MMF) in Lupus Nephritis (III/IV/V)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: 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
Brief 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 Summary:
- 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.
- 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.
- To explore the dosing of FK506 combined with MMF and their effective range of blood concentration.
Sponsor: Nanjing University School of Medicine
Current Primary Outcome: To assess the efficacy of FK506 combined with MMF versus intravenous CTX pulses in treatment of LN [ Time Frame: 18 months ]
Original Primary Outcome: To assess the efficacy of FK506 combined with MMF vs intravenous CTX pulses in treatment of LN.
Current Secondary Outcome: To investigate the safety and tolerability of FK506 combined with MMF versus intravenous CTX pulses [ Time Frame: 18 months ]
Original Secondary Outcome: To investigate the safety and tolerability of FK506 combined with MMF vs intravenous CTX pulses.
Information By: Nanjing University School of Medicine
Dates:
Date Received: March 1, 2006
Date Started: September 2005
Date Completion:
Last Updated: September 28, 2011
Last Verified: September 2011
