REduced-dose Steroid PrOtocol for Childhood Nephrotic SyndromE (RESPONSE)
Trial Parameters
Brief Summary
This is a pilot feasibility study for a proposed full-scale randomized controlled trial to evaluate the effectiveness and safety of a reduced-dose oral prednisone (steroids) regimen to treat childhood steroid-sensitive nephrotic syndrome relapses versus standard-dose prednisone (i.e., usual standard of care). This internal pilot study is a single-center, open-label, randomized controlled trial at The Hospital for Sick Children (Toronto, ON, Canada). The primary objective of this pilot study is to determine the feasibility, safety, and resources needed to conduct the future full-scale randomized controlled trial.
Eligibility Criteria
Inclusion Criteria: 1. Provide informed consent ± assent 2. Participant age 1-18 years 3. Diagnosis of idiopathic nephrotic syndrome (defined as nephrotic-range proteinuria \[first morning or 24-hour urine protein/creatinine ratio ≥200mg/mmol or ≥3+ protein on dipstick\] and either hypoalbuminemia \[serum albumin \<30g/L\] or edema) 4. Active nephrotic syndrome relapse at time of enrolment (defined as recurrence of nephrotic-range proteinuria \[≥3+ protein on dipstick for ≥3 consecutive days18 OR first morning or 24-hour urine protein/creatinine ratio ≥200mg/mmol AND ≥1+ protein on dipstick for ≥3 consecutive days\]) 5. Ability to take oral medication and willingness to adhere to either study prednisone regimen 6. Ability and willingness to adhere to home urine and symptom monitoring during the initial two-week period after assigned treatment initiation 7. Have not been previously included in the RESPONSE trial 8. Participant located in Ontario, Canada at the time of study enrolment