Nephrotic Syndrome
Conditions
Brief summary
Parallel group double blind randomised in patients with first episode corticosteroid sensitive nephrotic syndrome comparing time to relapse and adverse effects associated with a longer tapering steroid regimen with standard regime
Interventions
DRUGlong term tapering of prednisolone
60mg/m2/day (0-4 weeks); 60mg/m2 alternate days (5-6 weeks); 50mg/m2 alternate days (week 7-8); 40mg/m2 alternate days (week 9-10); 30mg/m2 alternate days (week 11-12); 20mg/m2 alternate days (week 13-14); 10mg/m2 alternate days (week 15-16)
DRUGstandard prednisolone treatment
60mg/m2/day week 0-4; 40mg/m2 on alternate days week 5-8
Sponsors
Institute of Child Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
1 Years to 15 Years
Healthy volunteers
No
Inclusion criteria
* newly presenting nephrotic syndrome, urine albumin/protein creatinine ratio \>200mg/mmol on early morning urine sample, hypoalbuminemia (\<25g/L)
Exclusion criteria
* prior treatment with steroids or cytotoxic agents underlying systemic disorder or exposure to agents known to be associated with newly presenting steroid sensitive nephrotic syndrome
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to first relapse | 5 months |
| Assessment of steroid induced morbidity | 5 months |
Secondary
| Measure | Time frame |
|---|---|
| serious adverse events | 5 months |
| frequent relapsing and steroid dependant disease | 5 months |
| Achenbach child behaviour checklist | 5 months |
| use of other immunosuppressive agents | 5 months |
| Time to relapse | 5 months |
Countries
United Kingdom
Contacts
Primary ContactRichard Trompeter
Outcome results
None listed