Study to see if steroids reduce kidney problems in Henoch Schonlein purpura

Randomised, placebo-controlled trial to assess the role of early prednisolone on the development and progression of Henoch Schonlein purpura nephritis

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN71445600

Enrollment

368

Registered

2011-11-30

Start date

2001-01-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Henoch Schonlein Purpura Haematological Disorders Allergic purpura

Interventions

Prednisolone 2mg/Kg/d (max 80mg) versus placebo for 7 days, then 1mg/kg/day for 7days to complete a 14 day course. Follow-up 1 year from baseline visit

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
1. The presence of proteinuria at 12 months (defined as urine protein: creatinine ratio (UP:UC)>20mg/mmol) 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 3. The association of polymorphisms of the ACE gene with proteinuria at 12 months	—

Measure

Time frame

1. The presence of proteinuria at 12 months (defined as urine protein: creatinine ratio (UP:UC)>20mg/mmol) 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 3. The association of polymorphisms of the ACE gene with proteinuria at 12 months

—

Secondary

Measure	Time frame
Presence of symptoms of possible trial medication induced toxicity: hypertension and/or gastrointestinal (GI) upset	—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 10, 2026