An interventional study of Tacrolimus+Mycophenolate mofetil and Cyclophosphamide in Lupus Nephritis, sponsored by Zhi-Hong Liu, M.D.. Completed at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2013-08-29.
Sponsored by Zhi-Hong Liu, M.D. · Not applicable, Interventional, and Treatment
The purpose of this study is to assess the efficacy and safety of multi-target therapy in the treatment of class Ⅲ,Ⅳ,Ⅴ,Ⅲ+Ⅴand Ⅳ+Ⅴ lupus nephritis.
245 studies on the registry are indexed under Nephritis; 56 are open to participants now.
This study's enrollment of 362 is above the median of 49 across 156 interventional studies indexed under Nephritis.
Browse Nephritis studies →Zhi-Hong Liu, M.D. is the lead sponsor of 9 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
History of present illness:
Other active diseases, such as:
FK506 4mg/d+MMF 1.0g/d
Drug: Tacrolimus+Mycophenolate mofetil
CTX iv 0.75 g/m2 body surface area (BSA)
Drug: Cyclophosphamide
FK506 4mg/d,MMF 1.0g/d
Also known as: FK506+MMF
CTX 0.75g/m2 BSA
Also known as: 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.
The primary endpoint is the rate of complete remission at 24 weeks.
Time frame: 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.
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.
Time frame: 24 weeks
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.
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.
Time frame: 24 weeks
This study is completed, as verified in Aug 2013. You cannot join it, but the record below documents what was studied.
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Zhi-Hong Liu, M.D.