Clinical Trial: Assess the Efficacy and Safety of Multi-target Therapy in Lupus Nephritis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: An Multi-site, Open, Prospective Study to Assess the Efficacy and Safety of Multi-target Therapy in the Treatment of Class Ⅲ,Ⅳ,Ⅴ,Ⅲ+Ⅴand Ⅳ+Ⅴ

  • To assess the efficacy of FK506 combined with MMF vs intravenous cyclophosphamide (CTX) pulses in treatment of class Ⅲ,Ⅳ,Ⅴ,Ⅲ+Ⅴand Ⅳ+Ⅴ Lupus Nephritis (LN).
  • To investigate the safety and tolerability of FK506 combined with MMF vs intravenous CTX pulses in the treatment of class Ⅲ,Ⅳ,Ⅴ,Ⅲ+Ⅴand Ⅳ+Ⅴ LN.

    • Sponsor: Zhi-Hong Liu, M.D.

    Current Primary Outcome: To assess the efficacy of FK506 combined with MMF vs intravenous CTX pulses in treatment of class Ⅲ, Ⅳ,Ⅴ, Ⅲ+Ⅴand Ⅳ+Ⅴ LN. [ Time Frame: 24 weeks ]

    The primary endpoint is the rate of complete remission at 24 weeks.


    Original Primary Outcome: To assess the efficacy of FK506 combined with MMF vs intravenous CTX pulses in treatment of class Ⅲ, Ⅳ,Ⅳ+Ⅴ, Ⅲ+Ⅴ or Ⅴ LN. [ Time Frame: 2.5 years ]

    Current Secondary Outcome: To investigate the other efficacy indicators of FK506 combined with MMF vs intravenous CTX pulses in the treatment of class Ⅲ, Ⅳ,Ⅴ, Ⅲ+Ⅴand Ⅳ+Ⅴ LN. [ Time Frame: 24 weeks ]

    The secondary endpoints include total remission, time to complete remission and remission, rate of complete remission and remission in patients with different types of LN, changes between baseline and after 24 week of induction treatment in proteinuria, albumin, SCr, eGFR, complement, autoantibodies, SLE-DAI and dosage and concentration of immunosuppressants between groups.


    Original Secondary Outcome: To investigate the safety and tolerability of FK506 combined with MMF vs intravenous CTX pulses in the treatment of class Ⅲ, Ⅳ, Ⅳ+Ⅴ, Ⅲ+Ⅴ or Ⅴ LN. [ Time Frame: 2.5 years ]

    Information By: Nanjing University School of Medicine

    Dates:
    Date Received: April 6, 2009
    Date Started: April 2009
    Date Completion:
    Last Updated: August 28, 2013
    Last Verified: August 2013