None listed
Conditions
Brief summary
Nephrotic syndrome (NS) affects around 1 in 50,000 children. Nephrotic syndrome causes the kidneys to leak too much protein into the urine leading to a drop in protein levels in the blood. This causes swelling in the body, especially in the face, legs and feet. The treatment of NS is steroid therapy. Most children with NS get better with steroid therapy but for many children, the disease comes back (relapses). NS often continues to relapse for many years. Steroids can help in treating relapses but they come with many side effects like changes in behaviour and sleep, appetite, weight and growth.
Interventions
This is a randomized, multicentre, controlled trial aimed to determine if equivalent outcomes can be achieved using half dose (low intensity) prednisolone compared to current standard of care (high intensity), to treat children at the time of relapse of steroid-sensitive idiopathic nephrotic syndrome (SSNS).
There are two phases to this study, the induction phase (at the time of relapse) and the consolidation phase (at the time of remission).
Relapse is defined as level of proteinuria of gre
This is a randomized, multicentre, controlled trial aimed to determine if equivalent outcomes can be achieved using half dose (low intensity) prednisolone compared to current standard of care (high intensity), to treat children at the time of relapse of steroid-sensitive idiopathic nephrotic syndrome (SSNS). There are two phases to this study, the induction phase (at the time of relapse) and the consolidation phase (at the time of remission). Relapse is defined as level of proteinuria of greater than or equal to 3+ on urinalysis for greater than or equal to 3 days, or greater than or equal to 3+ on urinalysis with oedema (greater than or equal to 3+ on urinalysis considered equivalent to a urine protein-to-creatinine of 200mg/mmol). Remission is defined as trace or negative proteinuria on urinalysis for 3 consecutive days (trace or negative on urinalysis considered equivalent to a urine protein-to-creatinine of less than or equal to 20mg/mmol). At the time of relapse of SSNS, eligible study participants enter the induction phase and are randomized to receive either a low-intensity (intervention arm) or high-intensity (control arm). The control arm will receive standard of care treatment per International Paediatric Nephrology Association (IPNA guidelines), which is 60mg/m2 prednisolone daily (administered in capsule form) until remission. The intervention arm will receive the same duration of prednisolone, but at half of the dose-30mg/m2 daily until remission. When participants meet the definition of remission, they enter the consolidation phase and randomised again to either low-intensity (intervention arm) or high-intensity (control arm). The control arm will receive standard of care treatment per IPNA guidelines which is 40mg/m2 every other day for four weeks The intervention arm will receive the same duration of prednisolone, but at half the dose- 20mg/m2 every other day for four weeks.
Sponsors
Flinders University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
1 Years to 15 Years
Healthy volunteers
No
Inclusion criteria
• Children between 1 and 15 years of age, inclusive • With a relapse of Idiopathic Nephrotic Syndrome (INS) • Whose last relapse (or initial presentation if this is the first relapse since) responded to prednisolone within 4 weeks (i.e. are steroid-sensitive) • Not taking > 15 mg/m2 daily prednisolone at the time of recruitment or in the prior 2 weeks
Exclusion criteria
• Familial nephrotic syndrome: another first-degree relative with INS • For children who have undergone kidney biopsy, findings other than minimal change disease or focal segmental glomerulosclerosis • Children with a documented history of significant non-adherence or inability to perform daily urine dipsticks at home • Children unable to take prednisolone capsules, even in crushed form mixed with food • Any other condition resulting in life expectancy less than one year or that in the opinion of the investigator would present a serious safety risk to the participant.
Outcome results
None listed