Extrait

Background and study aims Steroid-sensitive nephrotic syndrome (SSNS) is the most common kidney disease of childhood. Large amounts of protein are leaked into the urine resulting in generalised oedema (swelling). It is treated with high-dose oral prednisolone, a steroid drug which is effective, though associated with a number of serious side effects. Following successful initial treatment, 70-80% of children develop relapses where leakage of protein into the urine recurs. These are associated with a risk of significant complications. Relapse of nephrotic syndrome is treated with a further course of high-dose prednisolone, further increasing the risk of side effects. Children are kept off school, resulting in educational impairment and parental absence from work. Around 50% of children suffer frequent relapses (four or more per year). In this situation, attempts are made to reduce prednisolone exposure using other more potent drugs such as ciclosporin and cyclophosphamide, which are associated with other significant side effects. It is therefore logical to attempt to reduce the frequency of relapses. There is known to be a strong link between viral upper respiratory tract infection (URTI, the common cold) and the development of relapse of nephrotic syndrome. Three previous small studies have suggested that the use of a short course of daily prednisolone at the time of URTI reduces the rate of disease relapse. This study aims to find out whether the use of such therapy effectively and safely reduces the rate of relapse in a large population of UK children. Who can participate? Participants aged over 1 year and less than 19 years will be eligible if they have relapsing SSNS, defined as having experienced two or more relapses in the previous 12 months. What does the study involve? We will randomly allocate 300 children with relapsing SSNS to receive either 6 days of daily prednisolone or continue unchanged on their existing therapy (the current standard of care) each time they develop a URTI over a 12-month period. We will assess the frequency of URTI-related relapse of nephrotic syndrome in both groups and look carefully for side effects of treatment. The 300 participants will be recruited from over 100 UK hospitals. What are the possible benefits and risks of participating? Participants will receive a 6-day course of prednisolone each and every time they develop an URTI over the 12-month study period. There is the risk that this course of action will increase overall steroid exposure without reducing relapse rate. We will be monitoring patients every 3 months and will carefully document side effects, including impact on behaviour. Those children who experience steroid toxicity during the course of the study will have their background immunosuppressive treatment enhanced in an attempt to reduce relapse frequency. There will be no additional study visits for the purposes of the study alone. The three monthly visits are in keeping with routine care in children with relapsing nephrotic syndrome. Where is the study run from? Birmingham Clinical Trials Unit (UK). When is the study starting and how long is it expected to run for? Recruitment will begin in early 2013 and continue for a 2-year period. Each subject will be followed-up every 3 months over a period of 1 year which is in keeping with routine clinical practice. The study will run for a total of 4 years. Who is funding the study? The National Institute for Health Research (NIHR) Health Technology Assessment programme. Who is the main contact? Dr Nicholas Webb (Chief Investigator) [email protected]

Critère d'inclusion

• Steroid-sensitive nephrotic syndrome

Liens

• isrctn
• ictrp