Study to see if steroids reduce kidney problems in Henoch Schonlein purpura
Completed
- Conditions
- Henoch Schonlein PurpuraHaematological DisordersAllergic purpura
- Registration Number
- ISRCTN71445600
- Lead Sponsor
- niversity Hospital of Wales NHS Trust (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 368
Inclusion Criteria
Children under 18 years of age presenting to secondary care centres in England and Wales with a diagnosis of Henoch-Schönlein Purpura (HSP), based on the American College of Rheumatology Criteria
Exclusion Criteria
1. Those already receiving steroid / immunosuppressive therapy
2. Those receiving Angiotensin converting enzyme (ACE) inhibitors
3. Those with pre-existing renal disease (excluding urinary tract infections)
4. Those with pre-existing hypertension
5. Those with evidence of immunodeficiency /systemic infection
6. Those with contra-indications or relative contra-indications for steroid therapy (epilepsy, diabetes mellitus, glaucoma or peptic ulceration)
7. Those with characteristic purpuric rash for more than 7 days
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. The presence of proteinuria at 12 months (defined as urine protein: creatinine ratio (UP:UC)>20mg/mmol)<br>2. The need for additional treatment (defined as the presence of hypertension (requiring treatment) and / or renal biopsy anomalies and / or the need for treatment of renal disease) during the 12 month study period<br>3. The association of polymorphisms of the ACE gene with proteinuria at 12 months
- Secondary Outcome Measures
Name Time Method Presence of symptoms of possible trial medication induced toxicity: hypertension and/or gastrointestinal (GI) upset