Dupilumab for nephrotic syndrome in children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase II, double‑blind, randomized placebo‑controlled trial comparing subcutaneous dupilumab to placebo in children with steroid‑dependent or frequently relapsing steroid‑sensitive nephrotic syndrome. Participants receive injections for 24 weeks (every 2 weeks if ≥30 kg or every 4 weeks if <30 kg) while undergoing a supervised prednisolone wean and performing daily urine protein monitoring. The primary endpoint is time to relapse, with safety and adverse events closely recorded during the randomized phase. Children who relapse and were on placebo may enter a 24‑week open‑label extension to receive dupilumab.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. 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
2. Steroid-dependent disease or frequently relapsing disease prior to commencement of maintenance immunosuppression
3. 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
4. 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
5. In complete remission at the time of recruitment
6. Competent with, and compliant to, daily urine protein monitoring with Albustix

Exclusion Criteria:

1. Pre-existing ophthalmological conditions except refractive errors, squint or mild cataract
2. Current symptoms of helminth infection or travel to endemic areas, unless helminth infection is excluded
3. eGFR (by Bedside Schwartz equation) \<60 ml/min/1.73m2
4. Received Rituximab or other B-cell depleting agents within the last 1 year
5. Biopsy proven focal segmental glomerulosclerosis
6. Known ongoing infection including HIV, Hepatitis B, Hepatitis C or tuberculosis, otherwise immunosuppressed or with frequent infections
7. Known or suspected non-compliance to medication or follow-up
8. Pregnancy or intention to become pregnant
9. Major systemic conditions, i.e. ASA Physical Status III-IV.
10. Known hypersensitivity to dupilumab or any of its excipients

Where it's running

• National University Hospital
  Singapore, Singapore, Singapore Recruiting
• KK Women's and Children's Hospital
  Singapore, Singapore, Singapore Recruiting

Study contacts

• Principal investigator: Hui Kim Yap — National University Hospital, Singapore
• Study coordinator: David Lu
• Email: david_lu@nuhs.edu.sg
• Phone: +65 8044 1290

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.