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

What this Trial Is About

Researchers are studying whether dupilumab can treat severe nephrotic syndrome in children aged 6 to 18 years. This phase II randomized controlled trial compares dupilumab to a placebo to see if it reduces the time until nephrotic syndrome relapses and to evaluate any medical problems that occur while taking the medication. The study focuses on children with steroid-dependent or frequently relapsing steroid-sensitive nephrotic syndrome who are already on maintenance therapy with oral prednisolone, mycophenolate, or levamisole. Participants will receive subcutaneous injections of dupilumab or a matching placebo for 24 weeks, with dosing based on their weight. Those weighing 30 kg or more get injections every two weeks, while those under 30 kg receive injections every four weeks. After starting the injections, participants will gradually reduce their prednisolone dose. If a participant's urine shows protein (indicating relapse), their study treatment will be unmasked. If they were on placebo, they can join an open-label extension phase to receive dupilumab for another 24 weeks. Throughout the study, participants will visit the clinic every two weeks for checkups and tests. They will keep a nephrotic diary to record daily urine protein dipstick results and prednisolone doses. Researchers will measure the time to relapse, protein levels in urine, prednisolone dose changes, and quality of life. The study monitors safety and effectiveness up to 24 weeks, with an option for extended treatment if relapse occurs during the placebo phase.

Dupilumab Therapy in Nephrotic Syndrome in Children