None listed
Conditions
Brief summary
Initial treatment for Idiopathic childhood nephrotic syndrome is prednisolone. In Victoria our routine duration of prednisolone treatment has been 12 weeks, with a multi-step tapering dose used after 4 weeks of treatment. An alternative regime is used elsewhere in Australia, which has a two-step wean over 8 weeks. Prednisolone courses can rarely be complicated by a side effect called adrenal suppression, which is where natural adrenal gland steroid production is reduced. The Initial Prednisolone Weaning and Adrenal Suppression in Childhood Nephrotic Syndrome study is a clinical trial that will compare the two different courses of prednisolone, the multi-step wean over 12 weeks and the two-step wean over 8 weeks, in patients with their first presentation of idiopathic childhood nephrotic syndrome. The study will find out how frequently adrenal suppression occurs after different courses of prednisolone, and whether there is any association with nephrotic relapse.
Interventions
Oral prednisolone therapy for initial presentation of Childhood Nephrotic Syndrome. Dosing regimen will be followed for this period whether in hospital or at home.
Arm 1- 2 step wean 60mg/m2/day for 4 weeks, then 40mg/m2/alternate day for 4 weeks
Arm 2- control
Sponsors
Dr Amelia Le Page
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
2 Years to 15 Years
Healthy volunteers
No
Inclusion criteria
Age 2-<16 years First episode of idiopathic nephrotic syndrome
Exclusion criteria
Past or current pituitary or adrenal disease
Outcome results
None listed