Singapore-Malaysian Renal Trials - Nephrotic Syndrome (SMART-NS): Dupilumab Maintenance Therapy for Steroid-dependent and Frequently Relapsing Nephrotic Syndrome

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug, Biological
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 18
Healthy Volunteers: f
View:

• Age between 6 years old and 18 years old at the point of recruitment with idiopathic nephrotic syndrome with disease onset between 1-18 years old

• Steroid-dependent disease or frequently relapsing disease prior to commencement of maintenance immunosuppression

• On oral prednisolone +/- mycophenolate or levamisole only as maintenance therapy for 6 months or more, and with inadequate disease control or steroid toxicity on therapy

• Nephrotic relapse or partial relapse (clinical or biochemical) within the last 1 year either unprovoked or during prednisolone wean, and which responded to increase in steroids

• In complete remission at the time of recruitment

• Competent with, and compliant to, daily urine protein monitoring with Albustix

Locations
Other Locations
Singapore
KK Women's and Children's Hospital
RECRUITING
Singapore
National University Hospital
RECRUITING
Singapore
Contact Information
Primary
David Lu
david_lu@nuhs.edu.sg
+65 8044 1290
Time Frame
Start Date: 2025-11-27
Estimated Completion Date: 2028-02-28
Participants
Target number of participants: 66
Treatments
Experimental: Dupilumab
Participants in the experimental arm will receive subcutaneous Dupilumab for 24 weeks at the following weight-based doses, which are identical to doses used in the treatment of atopic dermatitis (higher than that for asthma), i.e.~* Regime A (15 to \<30kg): 600mg once, then 300mg every 28 days x 5 doses.~* Regime B (30 to \<60kg): 400mg once, then 200mg every 14 days x 11 doses.~* Regime C (60kg or more): 600mg once, then 300mg every 14 days x 11 doses.
Placebo_comparator: Placebo
Participants in the control arm will receive a subcutaneous injection of matched placebo (normal saline) at the same dosing intervals as the experimental arm for 24 weeks.
Other: Open label extension phase
On relapse, participants will be unmasked. Participants who were randomised to the placebo group will be invited to enrol into an open label extension phase. Participants will receive dupilumab in a regime identical to the experimental arm.
Related Therapeutic Areas
Sponsors
Collaborators: KK Women's and Children's Hospital, National University of Singapore, National Medical Research Council (NMRC), Singapore
Leads: National University Hospital, Singapore

This content was sourced from clinicaltrials.gov