Dupilumab Therapy in Nephrotic Syndrome in Children

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age6-18
SponsorNational University Hospital, Singapore

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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) <60 ml/min/1.73m2

Received Rituximab or other B-cell depleting agents within the last 1 year

Trial design

Treatments tested in this trial

  • Dupilumab
  • Placebo
  • Co-intervention of Prednisolone wean during randomised controlled phase
  • Dupilumab open label extension phase
  • Co-intervention of Prednisolone wean during open label extension phase

Treatment groups

66 Participants
are divided into 3 treatment groups

Sponsors and collaborators

National University Hospital, Singapore

Lead sponsor

National Medical Research Council (NMRC), Singapore

Collaborator

KK Women's and Children's Hospital

Collaborator

National University of Singapore

Collaborator