Dettagli per singolo studio

DEC-NET Serial number GB400

Published online	16/05/2005 14.48.00
Last updated	06/03/2006 14.27.44

Other protocol ID number	M0048086115
This trial has been approved by an ethics committee
Current trial status	Complete(closed to recruitment of participants: follow-up complete)
First subject enrolment Target N. of subjects	01/2001 368
Major Disease (ICD9 class)	ALLERGIC PURPURA
Experimental drug
PREDNISOLONE Treatment regimen (dosage and duration) 2mg/kg for 1 week; then 1mg/kg for 1 week
Gender	Both
Age (range)	0-18
Eligibility criteria
Inclusion criteria
Within 7 days of onset of Henoch Schonlein Purpura rash
Exclusion criteria
. Those children already receiving steroid or other immunosuppressive therapy . Children receiving ACE inhibitors . Children with pre-existing renal disease and/or hypertension . Immunosuppressed children . Children with systemic infections . Children with contra-indications and relative contra-indications to receiving steroid therapy: . Epilepsy on treatment . Diabetes Mellitus . Glaucoma . Peptic ulceration
Trial design/methodology
Phase	1
Kind of study	Efficacy
Design	Controlled Randomised Blinded Double blind
Purpose of study
1. To establish whether steroids reduce the incidence and severity of nephropathy in HSP. 2. To ascertain whether ACE genotype polymorphisms are predictive of progressive nephropathy in HSP.
Primary outcomes
1. The presence of proteinuria >20mg/mmol creat, 12 months after initial presentation in treated and untreated groups 2. The presence of hypertension and/or renal biopsy anomalies and/or the need for treatment of renal disease during the 12 month study period 3. Determination of ACE genotype and association with proteinuria, hypertension and renal insufficiency.
Secondary outcomes
1. Symptoms of drug-induced toxicity: Hypertension/ GI upset. Both may be due to the disease itself, rather than the steroids. These will be analysed at the end of the study.
Summary of study design, objectives, and ongoing research findings
Main aims and objectives 1. Assessment of the efficacy of early treatment with steroids on incidence and progression of nephropathy, determined by the presence or absence of significant proteinuria (>20mg/mmol creat), 12 months after initial presentation. 2. Determination of the association of insertion and deletion polymorphisms in the gene for angiotensin converting enzyme (ACE) with progressive nephropathy using clinical and laboratory indicators of disease severity, namely degree of haematuria, proteinuria and hypertension. 3. Study into the epidemiology of HSP using referrals to general paediatricians in district and regional centres with particular reference to the incidence and severity of urinary involvement at presentation and subsequently.