Actively Recruiting
Dupilumab Therapy in Nephrotic Syndrome in Children
Led by National University Hospital, Singapore · Updated on 2025-12-05
66
Participants Needed
2
Research Sites
117 weeks
Total Duration
On this page
Sponsors
N
National University Hospital, Singapore
Lead Sponsor
N
National Medical Research Council (NMRC), Singapore
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Dupilumab Therapy in Nephrotic Syndrome in Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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, with inadequate disease control or steroid toxicity on therapy
- Nephrotic relapse or partial relapse within the last 1 year, either unprovoked or during prednisolone wean, 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
You will not qualify if you...
- Pre-existing ophthalmological conditions except refractive errors, squint or mild cataract
- Current symptoms of helminth infection or travel to endemic areas unless helminth infection is excluded
- eGFR (by Bedside Schwartz equation) below 60 ml/min/1.73m2
- Received Rituximab or other B-cell depleting agents within the last 1 year
- Biopsy proven focal segmental glomerulosclerosis
- Known ongoing infection including HIV, Hepatitis B, Hepatitis C or tuberculosis, otherwise immunosuppressed or with frequent infections
- Known or suspected non-compliance to medication or follow-up
- Pregnancy or intention to become pregnant
- Major systemic conditions, i.e. ASA Physical Status III-IV
- Known hypersensitivity to dupilumab or any of its excipients
AI-Screening
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Trial Site Locations
Total: 2 locations
1
National University Hospital
Singapore, Singapore, Singapore, 119228
Actively Recruiting
2
KK Women's and Children's Hospital
Singapore, Singapore, Singapore, 229899
Actively Recruiting
Research Team
D
David Lu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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