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Dupilumab Therapy in Nephrotic Syndrome in Children

Study acronym: SMART-NS
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Aug 1, 2025 to Nov 27, 2025
    • Site details revised at 2 of 2 sites
    • Eligibility criteria shortened, about 2 words
    v2
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this clinical trial is to learn if dupilumab works to treat severe nephrotic syndrome in children. It will also learn about the safety of dupilumab. The main questions it aims to answer are: * Does dupilumab reduce the time to relapse of nephrotic syndrome? * What medical problems do participants have when taking dupilumab? Researchers will compare dupilumab to a placebo (a look-alike substance that contains no drug) to see if dupilumab works to treat severe nephrotic syndrome. Participants will: * Receive an injection of dupilumab or placebo (just under the skin) every 2 weeks (if ≥30kg) or every 4 weeks (if \<30kg) for 24 weeks (6 months) * Wean down their prednisolone dose after starting the injections of dupilumab or placebo * Visit the clinic once every 2 weeks for checkups and tests * Keep a nephrotic diary to record down the urine dipstick result each day, together with the dose of prednisolone taken If protein returns in participant's urine, they will have completed the study at that point. However, if the participant is found to have received the placebo, they will be offered to receive dupilumab for up to 24 weeks.
Trial Details
NCT Number NCT07091175
Lead Sponsor National University Hospital, Singapore
Collaborators: National Medical Research Council (NMRC), Singapore, KK Women's and Children's Hospital, National University of Singapore
Conditions
(from sponsor)
Nephrotic Syndrome in Children, Nephrotic Syndrome Steroid-Dependent
Related terms Nephrotic Syndrome
Enrollment 66 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov