Could less steroid be just as good for kids with kidney disease?
NCT ID NCT06635720
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a lower dose of the steroid prednisone can treat relapses of nephrotic syndrome in children as effectively as the standard dose. Fifty children aged 1 to 18 with active relapses will be randomly assigned to either the reduced-dose or standard-dose regimen. The goal is to see if this approach is feasible and safe, potentially leading to fewer steroid side effects in the future.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Prednisone (steroid)
- What this could lead to
- If successful, this could lead to a safer, lower-dose steroid regimen for children with nephrotic syndrome, reducing side effects while maintaining disease control.
- What could go wrong
- This is a small pilot study (50 children) at one hospital, so results may not apply broadly. The lower dose might be less effective at controlling relapses.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Nov 2024
- Expected to finish
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Feb 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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1 year to 18 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 Exclusion Criteria: 1. Prednisone treatment (at any dose) for the active relapse episode for \>2-days prior to study enrolment 2. Relapse episode within the past 6-weeks (i.e., date of relapse onset within 6-weeks prior to date of enrolment) 3. Current receipt of high-dose maintenance prednisone therapy (dose \>0.6mg/kg on alternate days or \>0.3mg/kg daily) 4. Steroid-resistant nephrotic syndrome classification (defined as lack of complete remission within 6-weeks after initiating daily steroid treatment at a standard dose for the initial episode of nephrotic syndrome) 5. Congenital or monogenic cause of nephrotic syndrome (defined as age at diagnosis \<1-year or known/suspected monogenic cause of nephrotic syndrome) 6. Secondary cause of nephrotic syndrome (includes membranous nephropathy, post-infectious glomerulonephritis \[GN\], complement-mediated GN \[e.g., C3 glomerulopathy and immune complex-GN\], IgA nephropathy, IgA vasculitis, lupus nephritis, medication-induced nephrotic syndrome, malignancy-induced nephrotic syndrome, active hepatitis B or C infection, or active HIV infection) 7. Presence of moderate-to-severe peripheral edema (grade 3+; indentation depth ≥5mm and rebound time \>15 seconds) 8. Hospitalization since the onset of the active relapse episode 9. Acute kidney injury (KDIGO stage ≥1) since the onset of the active relapse episode 10. Active or prior known or suspected venous thromboembolism during a relapse episode 11. Active pregnancy or lactation 12. Any condition or diagnosis, that could in the opinion of the Principal Investigator or delegate interfere with the participant's ability to comply with study instructions, might confound the interpretation of the study results, or put the participant at risk
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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The Hospital for Sick Children
Toronto, Ontario, M5G 1E8, Canada
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Other studies related to the condition(s) this trial covers.
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