Condition category
Haematological Disorders
Date applied
30/10/2011
Date assigned
30/11/2011
Last edited
06/01/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Henoch Schonlein Purpura (HSP) is a rare condition that happens mostly in children where there is inflammation of small blood vessels. This causes a rash, stomach pains and joint pains and swelling, usually of the ankles and feet. HSP also commonly causes the kidneys to leak small amounts of blood or protein into the urine. About one in 20 patients will have serious kidney problems due to HSP. It is possible that treatment with tablets called steroids, may help to prevent children from developing kidney disease. This study aims to find out whether treatment with a steroid (called prednisolone) can prevent or reduce the kidney complications of HSP.

Who can participate?
Children and young people up to the age of 18 with a diagnosis of HSP are invited to take part in the study.

What does the study involve?
Children and young people with HSP will be assigned to receive either a steroid in the form of a tablet or syrup, or a preparation that contains no medicinal products. Parents, patients and doctors will not be told of the type of treatment allocated, so as to avoid any bias. The tablets / liquid must be taken daily for 14 days and must be started within 7 days of the onset of the rash.
As part of the study protocol all children with Henoch Schonlein Purpura (HSP) will be seen in the hospital 4 weeks, 3 months and 12 months after the first presentation. At these visits we will take the blood pressure and check the urine for protein and blood. In addition, all patients should be seen either by the GP or at the local hospital for blood pressure and urine checks weekly for the first 4 weeks. Those who develop kidney complications will be followed up for as long as these problems persist.

What are the possible benefits and risks of participating?
During the research project Children and young people with HSP will be very closely monitored, and receive regular check-ups including routine urine testing. It is possible, that treatment with steroids, may help to prevent children and young people with HSP from developing kidney disease. Side effects of steroids are very unlikely for such a short course, but may include stomach upset (nausea, vomiting (which may be blood stained) or loss of blood from the back passage) and feeling faint. These symptoms may also be seen in untreated HSP

Where is the study run from?
The study will take place in 29 hospitals in England and Wales. The lead centre was University Hospital of Wales, Cardiff (UK).

When is the study starting and how long is it expected to run for?
The study will start in January 2001 and end in January 2005.

Who is funding the study?
The study is funded by Wales Office of Research and Development for Health and Social Care (UK).

Who is the main contact?
Dr Jan Dudley
jan.dudley@nhs.net

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jan Dudley

ORCID ID

Contact details

Department of Paediatric Nephrology
Bristol Royal Hospital for Children
Bristol
BS28BJ
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

R99/1/020

Study information

Scientific title

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

Acronym

Study hypothesis

Prednisolone would reduce the prevalence of proteinuria at a set point (12 months) after initial presentation of Henoch-Schonlein purpura

Ethics approval

Multicentre Research Ethics Committee approved on 14 December 1998, ref: MREC/98/6/68

Study design

Randomised double-blind placebo-controlled multi-centre study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Henoch Schonlein Purpura

Intervention

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

Intervention type

Drug

Phase

Not Applicable

Drug names

Prednisolone

Primary outcome measures

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 outcome measures

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

Overall trial start date

01/01/2001

Overall trial end date

31/01/2005

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

368

Participant 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

Recruitment start date

01/01/2001

Recruitment end date

31/01/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Paediatric Nephrology
Bristol
BS28BJ
United Kingdom

Sponsor information

Organisation

University Hospital of Wales NHS Trust (UK)

Sponsor details

c/o Mr Paul Davies
Heath Park
Cardiff
CF144XW
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.cardiffandvaleuhb.wales.nhs.uk/

Funders

Funder type

Government

Funder name

Wales Office of Research and Development for Health and Social Care (UK) (ref: R99/1/020)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23845696

Publication citations

  1. Results

    Dudley J, Smith G, Llewelyn-Edwards A, Bayliss K, Pike K, Tizard J, Randomised, double-blind, placebo-controlled trial to determine whether steroids reduce the incidence and severity of nephropathy in Henoch-Schonlein Purpura (HSP)., Arch. Dis. Child., 2013, 98, 10, 756-763, doi: 10.1136/archdischild-2013-303642.

Additional files

Editorial Notes