TerminatedPhase 3ACTRN12621001428853

Initial Prednisolone Weaning in Nephrotic Syndrome: adrenal suppression and its association with relapse

Initial Prednisolone Weaning and Adrenal Suppression in Childhood Nephrotic Syndrome


Sponsor

Dr Amelia Le Page

Enrollment

88 participants

Start Date

Jan 6, 2022

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 2 YearssMax Age: 15 Yearss

Inclusion Criteria2

  • Age 2-<16 years
  • First episode of idiopathic nephrotic syndrome

Exclusion Criteria1

  • Past or current pituitary or adrenal disease

Interested in this trial?

Get notified about updates and connect with the research team.

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 f

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


Locations(1)

VIC, Australia

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12621001428853