An interventional study of Cyclophosphamide in Henoch-Schoenlein Purpura, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-05-04.
Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Treatment
Henoch-Schonlein purpura is a leucocytoclastic systemic vasculitis involving small vessels with the deposition of immune complexes containing IgA. It is characterized by the association of skin, joint and gastrointestinal manifestations. Even though the evolution is usually simple, some patients, especially adults, may have severe visceral involvement including heart, lung, brain and renal disease. The best treatment is currently unknown. This study will test the safety and efficacy of steroids associated or not with cyclosphosphamide to treat the acute lesions and to prevent the development of chronic lesions.
The protocol test the role of 2 modalities of treatment (steroid vs. steroid and cyclophosphamide) for severe systemic form of Henoch-Schonlein purpura. The severe forms include extracapillary glomerulonephritis, myocarditis, pneumonitis, occult involvement, severe gastro-intestinal bleeding. No other randomized trial has been performed in adult patient for this indication.
36 studies on the registry are indexed under IgA Vasculitis; 12 are open to participants now.
This study's enrollment of 200 is above the median of 60 across 19 interventional studies indexed under IgA Vasculitis.
Browse IgA Vasculitis studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,592 studies on the registry; 1,033 are open to participants now.
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Exclusion criteria:
Cyclophosphamide
Drug: Cyclophosphamide
Cyclophosphamide
Birmingham Vasculitis Activity Score (BVAS)
Birmingham Vasculitis Activity Score (BVAS)
Time frame: during de study
Chronic lesions (Vasculitis Damage Index)
Chronic lesions (Vasculitis Damage Index)
Time frame: during the study
Renal function at 12 months
Renal function at 12 months
Time frame: during the study
Kidney survival at 12 months
Kidney survival at 12 months
Time frame: during the study
Patient survival at 12 months
Patient survival at 12 months
Time frame: during the study
Blood pressure
Blood pressure
Time frame: during th study
Infections
Infections
Time frame: during the study
Adverse events related to steroid or cyclophosphamide
Adverse events related to steroid or cyclophosphamide
Time frame: during the study
This study is completed, as verified in Mar 2007. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Cyclophosphamide
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