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New treatment option for Nephrotic Syndrome in Children
Official title Dupilumab Therapy in Nephrotic Syndrome in Children
ClinicalTrials.gov ID: NCT07091175
What this study is testing
What is Dupilumab?
Dupilumab is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for nephrotic syndrome in children.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 24 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 18
You may be able to join if
- 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...
- Nephrotic relapse or partial relapse (clinical or biochemical) within the last 1 year either unprovoked or during prednisolone wean, and which...
- In complete remission at the time of recruitment
You likely can't join if
- 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
- Biopsy proven focal segmental glomerulosclerosis
- Known ongoing infection including HIV, Hepatitis B, Hepatitis C or tuberculosis, otherwise immunosuppressed or with frequent infections
See the full eligibility criteria
- 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
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Singapore, Singapore, Singapore
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 24 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 6 years to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Singapore, Singapore, Singapore. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.