Henoch-Schoenlein Purpura
Conditions
Keywords
Vasculitis, Cyclophosphamide, Renal failure
Brief summary
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.
Detailed description
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.
Interventions
DRUGCyclophosphamide
Cyclophosphamide
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with Henoch-Schoenlein purpura * Patient's age \> 18 years
Exclusion criteria
* Patient presenting a purpura RHEUMATOID the diagnosis of which is confirmed by the histology presenting at least a visceral infringement(achievement) making consider the affection as engraves(burns) * of 18 or more years old Patient * Patient capable of understanding(including) the advantages and the risks of the try * Patient having given his assent lit in writing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Birmingham Vasculitis Activity Score (BVAS) | during de study | Birmingham Vasculitis Activity Score (BVAS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Renal function at 12 months | during the study | Renal function at 12 months |
| Kidney survival at 12 months | during the study | Kidney survival at 12 months |
| Patient survival at 12 months | during the study | Patient survival at 12 months |
| Chronic lesions (Vasculitis Damage Index) | during the study | Chronic lesions (Vasculitis Damage Index) |
| Infections | during the study | Infections |
| Adverse events related to steroid or cyclophosphamide | during the study | Adverse events related to steroid or cyclophosphamide |
| Blood pressure | during th study | Blood pressure |
Countries
France
Outcome results
None listed