Nephritis Clinical Trial
Official title:
MMF Versus Intravenous CTX Pulses in the Treatment of Adult Severe Henoch-Schonlein Purpura Nephritis
This study is performed to compare the efficacy, safety, tolerability and relapse of MMF vs CTX in the treatment of severe HSPN
Henoch-Schoenlein purpura nephritis (HSPN) with massive proteinuria,renal insufficiency and
crescent formation at onset have high risks of progressing to end stage renal failure.
Though clinical studies have shown that steroids in combination with cyclophosphamide could
reduce proteinuria and preserve renal function, this protocol is associated with many side
effects, and is not effective in some patients.
Recent studies have shown that mycophenolic acid(MPA), the active metabolite of
mycophenolate mofetil(MMF),could inhibit multifarious effects on endothelial cells,
including adhesion molecular expression, neutrophil attachment,IL-6 secretion, and the
process of angiogenesis, which contribute to the efficacy of MMF in the treatment of
vasculitis. Clinical studies also showed that MMF was effective in the treatment of lupus
nephritis with vasculitic lesions. These findings suggest that MMF might be effective in the
treatment of severe HSPN, which is a kind of vasculitic lesion. This prospective
open-labeled clinical trial study investigates the efficiency of MMF in the treatment of
severe HSPN compared with pulse intravenous cyclophosphamide. After 12 months of treatment,
we will assess the efficacy, safety, tolerability and relapse of MMF compared with
cyclophosphamide in the treatment of severe HSPN.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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