Short course daily prednisolone therapy at the time of upper respiratory tract infection in children with relapsing steroid sensitive nephrotic syndrome; the PREDNOS 2 study.

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Not specified

Target Recruitment: 360

Inclusion Criteria

Subjects aged over 1 year and less than 19 years will be eligible for inclusion if they have relapsing SSNS, defined as having experienced 2 or more relapses in the preceding 12 months. This will include the following groups:
•Subjects on no long-term immunosuppressive therapy;
•Subjects receiving long term maintenance prednisolone therapy at a dose of up to and including 15mg/m2 on alternate days. Note that this is the maximum dose at the time of recruitment – if children subsequently receive a higher dose e.g. after relapse, they can remain in the study;
•Subjects receiving long term maintenance prednisolone therapy at a dose of up to and including 15mg/m2 on alternate days in conjunction with other immunosuppressive therapies, including levamisole, ciclosporin, tacrolimus, MMF, mycophenolate sodium and azathioprine;
•Subjects receiving long-term immunosuppressive therapies, including levamisole, ciclosporin, tacrolimus, MMF, mycophenolate sodium and azathioprine without long term maintenance prednisolone therapy.
•Subjects who have previously received a course of oral or intravenous cyclophosphamide:
oMust have experienced two relapses in the 12 months prior to randomisation (in keeping with all other subjects)
oMust have experienced at least one of these relapses following completion of cyclophosphamide therapy
oMust be at least 3 months post completion of oral or intravenous cyclophosphamide therapy
•Subjects who have previously received a single dose or course of intravenous rituximab:
oMust have experienced two relapses in the 12 months prior to randomisation (in keeping with all other subjects)
oMust have experienced at least one of these relapses following completion of rituximab therapy
oMust be at least 3 months post completion of intravenous rituximab therapy
•Parents and (where age appropriate) subject understand the definition of URTI and the need to commence study drug once this definition has been met.
•Written informed consent obtained from the subject’s parents/guardians and written assent obtained from subject (where age appropriate). Subjects aged 16 years and above will provide their own written informed consent.

Are the trial subjects under 18? yes
Number of subjects for this age range: 280
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

•Subjects with steroid resistant nephrotic syndrome
•Subjects receiving, or within 3 months of completing a course of oral or intravenous cyclophosphamide
•Subjects receiving, or within 3 months of receiving a course of rituximab
•Subjects on daily prednisolone therapy at time of recruitment
•Subjects on a prednisolone dose of greater than 15mg/m2 on alternate days at time of recruitment
•Subjects with a documented history of significant non-adherence with medical therapy
•Subjects who will be transferred from paediatric to adult services during the 12 month study period.
•Subjects unable to take prednisolone tablets, even in crushed form.
•Known allergy to prednisolone

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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