Assess the Efficacy and Safety of Multi-target Therapy in Lupus Nephritis
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|ClinicalTrials.gov Identifier: NCT00876616|
Recruitment Status : Completed
First Posted : April 7, 2009
Last Update Posted : August 29, 2013
|Condition or disease||Intervention/treatment||Phase|
|Lupus Nephritis||Drug: Tacrolimus+Mycophenolate mofetil Drug: Cyclophosphamide||Not Applicable|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||362 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Lupus Nephritis|
|Study Start Date :||April 2009|
|Actual Primary Completion Date :||May 2011|
|Actual Study Completion Date :||February 2012|
Experimental: Tacrolimus+Mycophenolate mofetil
FK506 4mg/d+MMF 1.0g/d
Drug: Tacrolimus+Mycophenolate mofetil
FK506 4mg/d,MMF 1.0g/d
Other Name: FK506+MMF
Active Comparator: Cyclophosphamide
CTX iv 0.75 g/m2 body surface area (BSA)
CTX 0.75g/m2 BSA
Other Name: CTX
- 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.
- 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.
- To assess the Safety 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 ]Safety assessments include clinical manifestations, physical examination, laboratory tests laboratory tests (including hematology, serum chemistry, urinalysis), adverse events (including gastrointestinal toxicity and severe infections requiring antibiotics treatment) and concomitant medications.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00876616
|Research Institute of Nephrology,Jinling Hospital|
|Nanjing, Jiangsu, China, 210002|
|Principal Investigator:||Zhihong Liu, Master||Nanjing University School of Medicine|