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Open Access Study protocol

Short course daily prednisolone therapy during an upper respiratory tract infection in children with relapsing steroid-sensitive nephrotic syndrome (PREDNOS 2): protocol for a randomised controlled trial

Nicholas J A Webb118*, Emma Frew2, Elizabeth A Brettell3, David V Milford184, Detlef Bockenhauer185, Moin A Saleem186, Martin Christian187, Angela S Hall188, Ania Koziell189, Heather Maxwell1018, Shivram Hegde1118, Eric R Finlay1218, Rodney D Gilbert1318, Jenny Booth1418, Caroline Jones1518, Karl McKeever1618, Wendy Cook1718, Natalie J Ives3 and On behalf of the PREDNOS 2 study group

Author Affiliations

1 Department of Paediatric Nephrology and NIHR/Wellcome Trust Children's Clinical Research Facility, University of Manchester, Manchester Academic Health Science Centre, Royal Manchester Children's Hospital, Manchester, UK

2 Health Economics Unit, University of Birmingham, Birmingham, UK

3 Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK

4 Department of Paediatric Nephrology, Birmingham Children’s Hospital, Birmingham, UK

5 Department of Paediatric Nephrology, Great Ormond Street Hospital, London, UK

6 Children’s and Academic Renal Unit, University of Bristol, Bristol, UK

7 Department of Paediatric Nephrology, Nottingham Children’s Hospital, Nottingham, UK

8 Children’s Hospital, University Hospitals of Leicester, Leicester, UK

9 Department of Paediatric Nephrology, Evelina Children’s Hospital, London, UK

10 Renal Unit, Royal Hospital for Sick Children, Glasgow, UK

11 Children's Kidney Centre, University Hospital of Wales, Cardiff, UK

12 Department of Paediatric Nephrology, Leeds Children’s Hospital, Leeds, UK

13 Department of Paediatric Nephrology, University Hospital Southampton, Southampton, UK

14 Department of Paediatric Nephrology, Great North Children’s Hospital, Newcastle upon Tyne, UK

15 Department of Paediatric Nephrology, Alder Hey Children’s Hospital, Liverpool, UK

16 Department of Paediatric Nephrology, Royal Belfast Hospital for Sick Children, Belfast, UK

17 Nephrotic Syndrome Trust, Bristol, UK

18 National Institute for Health Research Medicines for Children Research Network Nephrology Clinical Studies Group, UK

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Trials 2014, 15:147  doi:10.1186/1745-6215-15-147

Published: 27 April 2014

Abstract

Background

Relapses of childhood steroid-sensitive nephrotic syndrome (SSNS) are treated with a 4- to 8-week course of high-dose oral prednisolone, which may be associated with significant adverse effects. There is a clear association between upper respiratory tract infection (URTI) and relapse development. Previous studies in developing nations have suggested that introducing a 5- to 7-day course of daily prednisolone during an URTI may prevent a relapse developing and the need for a treatment course of high-dose prednisolone. The aim of PREDNOS 2 is to evaluate the effectiveness of a 6-day course of daily prednisolone therapy during an URTI in reducing the development of a subsequent relapse in a developed nation.

Methods/design

The subjects will be 300 children with relapsing SSNS (≥2 relapses in preceding year), who will be randomised to receive either a 6-day course of daily prednisolone or no change to their current therapy (with the use of placebo to double blind) each time they develop an URTI over 12 months. A strict definition for URTI will be used. Subjects will be reviewed at 3, 6, 9 and 12 months to capture data regarding relapse history, ongoing therapy and adverse effect profile, including behavioural problems and quality of life. A formal health economic analysis will also be performed. The primary end point of the study will be the incidence of URTI-related relapse (3 days of Albustix +++) following the first infection during the 12-month follow-up period. DNA and RNA samples will be collected to identify a potential genetic cause for the disease. Subjects will be recruited from over 100 UK centres with the assistance of the Medicines for Children Research Network.

PREDNOS 2 is funded by the National Institute for Health Research Health Technology Assessment Programme (11/129/261).

Discussion

We propose that PREDNOS 2 will be a pivotal study that will inform the future standard of care for children with SSNS. If it is possible to reduce the disease relapse rate effectively and safely, this will reduce the morbidity and cost associated with drug treatment, notwithstanding hospital admission and parental absence from employment.

Trial registration

Current Controlled Trials (ISRCTN10900733).

Keywords:
Steroid sensitive nephrotic syndrome; Relapse; Upper respiratory tract infection; Prednisolone; Adverse effects; Health economic analysis