Nephrotic Syndrome in ChildrenPhase 2SMART-NSNCT07091175
Dupilumab Therapy in Nephrotic Syndrome in Children
A Phase 2 study testing Dupilumab, Dupilumab open label extension phase and Co-intervention of Prednisolone wean during open label extension phase in people with Nephrotic Syndrome in Children and Nephrotic Syndrome Steroid-Dependent, run by National University Hospital, Singapore at 2 sites in Singapore.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Nephrotic Syndrome in Children, Nephrotic Syndrome Steroid-Dependent
- What is being tested?
- Dupilumab, Dupilumab open label extension phase and Co-intervention of Prednisolone wean during open label extension phase
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 2 sitesSingapore
- Study dates
- 27 Nov 2025to 28 Feb 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore2 sites, 2 recruiting
- Recruiting
National University Hospital
Singapore, Singapore, 119228
David Lu, +65 8044 1290, david_lu@nuhs.edu.sg
David Lu
- Recruiting
KK Women's and Children's Hospital
Singapore, Singapore, 229899
Celeste Jia Ying Yap, +65 8044 1290, celeste.yap.j.y@singhealth.com.sg
Celeste Jia Ying Yap
About this study
Official title: Singapore-Malaysian Renal Trials - Nephrotic Syndrome (SMART-NS): Dupilumab Maintenance Therapy for Steroid-dependent and Frequently Relapsing Nephrotic Syndrome
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:
Read more
- 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.
Read the detailed description
This is a multi-centre phase II double blinded randomised controlled trial which aims to assess the safety and efficacy of dupilumab for the treatment of steroid dependent or frequently relapsing steroid sensitive nephrotic syndrome in children. Participants will be randomised to receive Dupilumab or placebo via subcutaneous injection for 24 weeks. The primary efficacy end point is time to relapse. Participants who relapse will be unmasked, and if found to have received placebo, will be eligible for the open label extension phase, in which they will receive dupilumab for the following 24 weeks.
- Being tested
- 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
- Keywords
- Dupilumab, Steroid sensitive nephrotic syndrome, Steroid dependent nephrotic syndrome, Frequently relapsing nephrotic syndrome, Paediatric
- Medical subject headings
- Nephrotic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DupilumabBiological
Subcutaneous injection of Dupilumab for 24 weeks (weight based dosing)
PlaceboDrug
Subcutaneous injection of normal saline placebo (matching dupilumab subcutaneous injection dosing) for 24 weeks
Co-intervention of Prednisolone wean during randomised controlled phaseDrug
The Prednisolone wean will commence 2 weeks after receiving the loading dose of Dupilumab/placebo, with each weaning step 2 weeks apart. Prednisolone will be first weaned to the same dose every other day, if the current dosing is daily (or more frequent). The dose will subsequently weaned to 4 pre-determined levels of 30mg/m2, 15mg/m2, 10mg/m2 and 5mg/m2 every other day, rounding up to the nearest 5mg. For instance, if the current dose of prednisolone is 12mg/m2 every other day, the patient will decrease the dose to 10mg/m2 every other day for 2 weeks, followed by 5mg/m2 every other day for 2 weeks, before discontinuing the drug.
If patients enter the trial on Mycophenolate or Levamisole, this will be continued for the duration of the trial at the same dose.
Dupilumab open label extension phaseBiological
Upon nephrotic relapse, participants will be unmasked. If they were given placebo, they will be invited to enrol in an open label extension phase to receive dupilumab for 24 weeks (with dosing identical to the experimental arm).
Co-intervention of Prednisolone wean during open label extension phaseDrug
Patients will also receive prednisolone 60mg/m2/day as a single daily dose (max 60-80mg OD according to physician's discretion) until in remission for 3 days, before prednisolone is weaned to 40mg/m2 every other day for 2 weeks. Doses should be rounded up to nearest 5mg where possible. Prednisolone will then be weaned in steps as per the randomised controlled phase. If patients do not enter full remission after 2 weeks from enrolment into the extension phase, they will be removed from the study. Additional agents, e.g. Mycophenolate, Levamisole, Calcineurin inhibitors should not be started during this time unless there is strong clinical indication.
| Study group | Role | What they receive |
|---|---|---|
| Dupilumab | Experimental | Participants in the experimental arm will receive subcutaneous Dupilumab for 24 weeks at the following weight-based doses, which are identical to doses used in the treatment of atopic dermatitis (higher than that for asthma), i.e.
* Regime A (15 to <30kg): 600mg once, then 300mg every 28 days x 5 doses.
* Regime B (30 to <60kg): 400mg once, then 200mg every 14 days x 11 doses.
* Regime C (60kg or more): 600mg once, then 300mg every 14 days x 11 doses. Receives: Biological: Dupilumab; Drug: Co-intervention of Prednisolone wean during randomised controlled phase |
| Placebo | Placebo comparator | Participants in the control arm will receive a subcutaneous injection of matched placebo (normal saline) at the same dosing intervals as the experimental arm for 24 weeks. Receives: Drug: Placebo; Drug: Co-intervention of Prednisolone wean during randomised controlled phase |
| Open label extension phase | Other | On relapse, participants will be unmasked. Participants who were randomised to the placebo group will be invited to enrol into an open label extension phase. Participants will receive dupilumab in a regime identical to the experimental arm. Receives: Biological: Dupilumab open label extension phase; Drug: Co-intervention of Prednisolone wean during open label extension phase |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to relapse
Relapse will be defined as either (a) urine dipstick ≥3+ on 3 consecutive days, with 1x urine protein creatinine ratio ≥200mg/mmol (2000mg/g), or (b) clinical edema in keeping with nephrotic syndrome accompanied by hypoalbuminaemia (serum albumin <30g/L), with 1x urine protein creatinine ratio ≥200mg/mmol (2000mg/g).
Participants will be expected to record down in a nephrotic diary the urine dipstick result each day, together with the dose of prednisolone taken. Participants are expected to inform the site principal investigator (or designate) if urine dipstick is ≥3+ on 3 consecutive days, and provisions will be made for an ad-hoc urine protein creatinine ratio measurement to determine if relapse has occurred. This should be done within 24 hours of notification by participants.
Participants will also be routinely examined for signs of nephrotic syndrome, for example edema, at study visits, and urine protein creatinine ratio will be obtained at each study visit.
Measured: From enrolment until date of relapse, assessed up to 24 weeks
Secondary outcomes (4)
Time-averaged Albustix quantitation of proteinuria during study period
Participants will be requested to record down in a nephrotic diary their urine dipstick result each day, together with the dose of prednisolone taken. The time-averaged albustix quantitation of proteinuria for the study period will then be calculated.
Measured: From enrolment until date of relapse, assessed up to 24 weeks
Minimum dose of prednisolone at the end of study
Minimum dose of prednisolone at the end of study - at time of relapse or at 24 weeks, whichever comes first.
Measured: From enrolment until date of relapse, assessed up to 24 weeks
Percentage reduction in prednisolone dose at the end of study compared to baseline
Percentage reduction in prednisolone dose at the end of study (at time of relapse or at 24 weeks, whichever comes first) compared to baseline
Measured: At baseline and at time of relapse or at 24 weeks, whichever comes first
Change in health-related quality of life at the end of study compared to baseline
Health-related quality of life will be measured using the Pediatric Quality of Life Inventory (PedsQL) 4.0 Generic Core scales short form. There are 15 questions, where each question is scored from 0 to 4. The total score ranges from 0 to 60, where a higher score represents a lower quality of life, with more problems associated with coping with health and activities, feelings, getting along with others and work/studies.
Measured: At baseline, 1 month, 3 months, 6 months (or at time of relapse, whichever comes first)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2025
- Study start27 Nov 2025
- Primary completion28 Feb 2028 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Nephrotic Syndrome in ChildrenStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel model with open label extension phase for participants who were randomised to placebo and relapsed
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- National Medical Research Council (NMRC), Singapore, KK Women's and Children's Hospital, National University of Singapore
- Responsible party
- Sponsor
- Investigators
- Hui Kim Yap, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07091175
- Sponsor's protocol ID
- SMART-NS 01
- Other IDs
- 2024/00054
- Acronym
- SMART-NS
- Status last verified
- Nov 2025
- First submitted
- 8 Jul 2025
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chan CY, Teo S, Lu L, Chan YH, Lau PY, Than M, Jordan SC, Lam KP, Ng KH, Yap HK. Low regulatory T-cells: A distinct immunological subgroup in minimal change nephrotic syndrome with early relapse following rituximab therapy. Transl Res. 2021 Sep;235:48-61. doi: 10.1016/j.trsl.2021.03.019. Epub 2021 Apr 1.
PubMed 33812063Lai KW, Wei CL, Tan LK, Tan PH, Chiang GS, Lee CG, Jordan SC, Yap HK. Overexpression of interleukin-13 induces minimal-change-like nephropathy in rats. J Am Soc Nephrol. 2007 May;18(5):1476-85. doi: 10.1681/ASN.2006070710. Epub 2007 Apr 11.
PubMed 17429054Yap HK, Cheung W, Murugasu B, Sim SK, Seah CC, Jordan SC. Th1 and Th2 cytokine mRNA profiles in childhood nephrotic syndrome: evidence for increased IL-13 mRNA expression in relapse. J Am Soc Nephrol. 1999 Mar;10(3):529-37. doi: 10.1681/ASN.V103529.
PubMed 10073603
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Singapore-Malaysian Renal Trials - Nephrotic Syndrome (SMART-NS): Dupilumab Maintenance Therapy for Steroid-dependent and Frequently Relapsing Nephrotic Syndrome
- ClinicalTrials.gov ID
- NCT07091175
- Acronym / sponsor ID
- SMART-NS / SMART-NS 01
- Keywords
- Dupilumab, Steroid sensitive nephrotic syndrome, Steroid dependent nephrotic syndrome, Frequently relapsing nephrotic syndrome, Paediatric
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Collaborators
- National Medical Research Council (NMRC), Singapore, KK Women's and Children's Hospital, National University of Singapore
- Study start
- 27 Nov 2025 (actual)
- Primary completion
- 28 Feb 2028 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 29 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a multi-centre phase II double blinded randomised controlled trial which aims to assess the safety and efficacy of dupilumab for the treatment of steroid dependent or frequently relapsing steroid sensitive nephrotic syndrome in children. Participants will be randomised to receive Dupilumab or placebo via subcutaneous injection for 24 weeks. The primary efficacy end point is time to relapse. Participants who relapse will be unmasked, and if found to have received placebo, will be eligible for the open label extension phase, in which they will receive dupilumab for the following 24 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Parallel model with open label extension phase for participants who were randomised to placebo and relapsed
| Arm | Type | Receives |
|---|---|---|
| Dupilumab | Experimental | Biological: Dupilumab, Drug: Co-intervention of Prednisolone wean during randomised controlled phaseParticipants in the experimental arm will receive subcutaneous Dupilumab for 24 weeks at the following weight-based doses, which are identical to doses used in the treatment of atopic dermatitis (higher than that for asthma), i.e. * Regime A (15 to <30kg): 600mg once, then 300mg every 28 days x 5 doses. * Regime B (30 to <60kg): 400mg once, then 200mg every 14 days x 11 doses. * Regime C (60kg or more): 600mg once, then 300mg every 14 days x 11 doses. |
| Placebo | Placebo comparator | Drug: Placebo, Drug: Co-intervention of Prednisolone wean during randomised controlled phaseParticipants in the control arm will receive a subcutaneous injection of matched placebo (normal saline) at the same dosing intervals as the experimental arm for 24 weeks. |
| Open label extension phase | Other | Biological: Dupilumab open label extension phase, Drug: Co-intervention of Prednisolone wean during open label extension phaseOn relapse, participants will be unmasked. Participants who were randomised to the placebo group will be invited to enrol into an open label extension phase. Participants will receive dupilumab in a regime identical to the experimental arm. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DupilumabSubcutaneous injection of Dupilumab for 24 weeks (weight based dosing) | Biological | Dupilumab |
| PlaceboSubcutaneous injection of normal saline placebo (matching dupilumab subcutaneous injection dosing) for 24 weeks | Drug | Placebo |
| Co-intervention of Prednisolone wean during randomised controlled phaseThe Prednisolone wean will commence 2 weeks after receiving the loading dose of Dupilumab/placebo, with each weaning step 2 weeks apart. Prednisolone will be first weaned to the same dose every other day, if the current dosing is daily (or more frequent). The dose will subsequently weaned to 4 pre-determined levels of 30mg/m2, 15mg/m2, 10mg/m2 and 5mg/m2 every other day, rounding up to the nearest 5mg. For instance, if the current dose of prednisolone is 12mg/m2 every other day, the patient will decrease the dose to 10mg/m2 every other day for 2 weeks, followed by 5mg/m2 every other day for 2 weeks, before discontinuing the drug. If patients enter the trial on Mycophenolate or Levamisole, this will be continued for the duration of the trial at the same dose. | Drug | Dupilumab, Placebo |
| Dupilumab open label extension phaseUpon nephrotic relapse, participants will be unmasked. If they were given placebo, they will be invited to enrol in an open label extension phase to receive dupilumab for 24 weeks (with dosing identical to the experimental arm). | Biological | Open label extension phase |
| Co-intervention of Prednisolone wean during open label extension phasePatients will also receive prednisolone 60mg/m2/day as a single daily dose (max 60-80mg OD according to physician's discretion) until in remission for 3 days, before prednisolone is weaned to 40mg/m2 every other day for 2 weeks. Doses should be rounded up to nearest 5mg where possible. Prednisolone will then be weaned in steps as per the randomised controlled phase. If patients do not enter full remission after 2 weeks from enrolment into the extension phase, they will be removed from the study. Additional agents, e.g. Mycophenolate, Levamisole, Calcineurin inhibitors should not be started during this time unless there is strong clinical indication. | Drug | Open label extension phase |
Primary outcome
Time to relapse
Time frame: From enrolment until date of relapse, assessed up to 24 weeks
Relapse will be defined as either (a) urine dipstick ≥3+ on 3 consecutive days, with 1x urine protein creatinine ratio ≥200mg/mmol (2000mg/g), or (b) clinical edema in keeping with nephrotic syndrome accompanied by hypoalbuminaemia (serum albumin <30g/L), with 1x urine protein creatinine ratio ≥200mg/mmol (2000mg/g). Participants will be expected to record down in a nephrotic diary the urine dipstick result each day, together with the dose of prednisolone taken. Participants are expected to inform the site principal investigator (or designate) if urine dipstick is ≥3+ on 3 consecutive days, and provisions will be made for an ad-hoc urine protein creatinine ratio measurement to determine if relapse has occurred. This should be done within 24 hours of notification by participants. Participants will also be routinely examined for signs of nephrotic syndrome, for example edema, at study visits, and urine protein creatinine ratio will be obtained at each study visit.
4 secondary outcomes
Time-averaged Albustix quantitation of proteinuria during study period
Time frame: From enrolment until date of relapse, assessed up to 24 weeks
Minimum dose of prednisolone at the end of study
Time frame: From enrolment until date of relapse, assessed up to 24 weeks
Percentage reduction in prednisolone dose at the end of study compared to baseline
Time frame: At baseline and at time of relapse or at 24 weeks, whichever comes first
Change in health-related quality of life at the end of study compared to baseline
Time frame: At baseline, 1 month, 3 months, 6 months (or at time of relapse, whichever comes first)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- Background: PubMed 33812063Chan CY, Teo S, Lu L, Chan YH, Lau PY, Than M, Jordan SC, Lam KP, Ng KH, Yap HK. Low regulatory T-cells: A distinct immunological subgroup in minimal change nephrotic syndrome with early relapse following rituximab therapy. Transl Res. 2021 Sep;235:48-61. doi: 10.1016/j.trsl.2021.03.019. Epub 2021 Apr 1.
- Background: PubMed 17429054Lai KW, Wei CL, Tan LK, Tan PH, Chiang GS, Lee CG, Jordan SC, Yap HK. Overexpression of interleukin-13 induces minimal-change-like nephropathy in rats. J Am Soc Nephrol. 2007 May;18(5):1476-85. doi: 10.1681/ASN.2006070710. Epub 2007 Apr 11.
- Background: PubMed 10073603Yap HK, Cheung W, Murugasu B, Sim SK, Seah CC, Jordan SC. Th1 and Th2 cytokine mRNA profiles in childhood nephrotic syndrome: evidence for increased IL-13 mRNA expression in relapse. J Am Soc Nephrol. 1999 Mar;10(3):529-37. doi: 10.1681/ASN.V103529.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hui Kim Yap principal investigator
National University Hospital, Singapore
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dupilumab, Dupilumab open label extension phase and Co-intervention of Prednisolone wean during open label extension phase in people with Nephrotic Syndrome in Children and Nephrotic Syndrome Steroid-Dependent, run by National University Hospital, Singapore at 2 sites in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David Lu (+65 8044 1290, david_lu@nuhs.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to relapse (time frame: From enrolment until date of relapse, assessed up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07091175, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.