An interventional study of Mycophenolate mofetil in Henoch-Schoenlein Purpura and Nephritis, sponsored by Nanjing University School of Medicine. Completed at 1 site in China. Open to participants aged 16 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-05-27.
Sponsored by Nanjing University School of Medicine · Not applicable, Interventional, and Treatment
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.
36 studies on the registry are indexed under IgA Vasculitis; 12 are open to participants now.
This study's enrollment of 60 is close to the median of 60 across 19 interventional studies indexed under IgA Vasculitis.
Browse IgA Vasculitis studies →Nanjing University School of Medicine is the lead sponsor of 39 studies on the registry; 5 are open to participants now.
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Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Mycophenolate mofetil
MMF,1.0g/d
Also known as: Mycophenolate mofetil,cellcept
To compare the efficacy,safety, tolerability and relapse of MMF vs CTX in the treatment of severe HSPN
Time frame: 12 months
The record gives a start of Jan 2003, a primary completion of May 2005 and a completion of Jan 2006. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Jul 2008. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Mycophenolic Acid
Nanjing University School of Medicine