Nephrotic Syndrome in ChildrenPhase 2NCT07087314
A Study of Anti-CD38 Monoclonal Antibody (SG301) Subcutaneous Injection in Children With Nephrotic Syndrome With Frequent Relapses or Steroid Dependence
A Phase 2 study testing SG301 Subcutaneous injection in people with Nephrotic Syndrome in Children, run by Mao Jianhua at 1 site in China.
Trial summary
This is an open - label study to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of SG301 Subcutaneous injection in children with frequently relapsing or steroid - dependent nephrotic syndrome. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Nephrotic Syndrome in Children
- What is being tested?
- SG301 Subcutaneous injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 25 Aug 2025to 9 Jul 2029
- 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
- Aged 6 - 18 years.
- Steroid-sensitive nephrotic syndrome with frequent relapses (FRNS) or steroid dependence (SDNS).
- Normal renal function: eGFR≥90 ml/min/1.73m².
- After steroid treatment, morning urine protein<1 + or urine protein/creatinine<0.2 g/g (<20 mg/mmol) for ≥3 consecutive days.
- Within 7 days before enrollment, blood tests (without growth factors or transfusions) must meet: hemoglobin>80 g/L; platelets>75×10⁹/L; neutrophils>1.5×10⁹/L.
- Prothrombin time/INR≤1.5×ULN, unless due to anticoagulation.
- No Tacrolimus, cyclosporine A, mycophenolate mofetil, belimumab, levamisole, azathioprine, or cyclophosphamide in prior 2 months; no rituximab or obinutuzumab in prior 6 months.
Who cannot join
- Family history of nephrotic syndrome, chronic glomerulonephritis, or uremia.
- Alanine aminotransferase >2×ULN or total bilirubin>2×ULN with a sustained increase for 2 weeks.
- HBsAg or HBcAb positive with Hepatitis B virus DNA above the lower limit of normal; Hepatitis C virus antibody - positive with Hepatitis C virus RNA positive; HIV antibody - positive.
- Chronic active infections (e.g., Epstein-Barr Virus, Cytomegalovirus, tuberculosis) that may worsen with steroids/ immunosuppressants.
- Acute active infection (excluding onychomycosis) requiring systemic antibiotics/antivirals.
- Secondary nephrotic syndrome (e.g.,immunoglobulin A - associated, lupus nephritis); steroid - resistant nephrotic syndrome (SRNS).
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- Other autoimmune diseases, primary immunodeficiency, or malignancy.
- Prior anti - cluster of differentiation 38 (CD38) treatment.
- Live/attenuated vaccine receipt or major surgery (non - diagnostic) within 4 weeks before first dose.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Children's Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310052
Jianhua Mao, Docter
About this study
Official title: A Clinical Study to Evaluate the Initial Efficacy and Safety of Anti-CD38 Monoclonal Antibody (SG301) Subcutaneous Injection in Children With Frequent Relapses or Steroid-Dependent Nephrotic Syndrome
This is an open - label study to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of SG301 Subcutaneous injection in children with frequently relapsing or steroid - dependent nephrotic syndrome.
Read the detailed description
This study will recruit children aged 6 - 18 with frequently relapsing or steroid - dependent nephrotic syndrome, who have morning urine protein < 1 + or urine protein / creatinine < 0.2 g/g (<20 mg/mmol) for at least three consecutive days after steroid treatment.
The study will stratify participants into two age groups:≥6 - <12 years and≥12 - <18 years. Recruitment will start with the 12 - 18 - year - old group. After collecting sufficient safety and clinical pharmacology data to support moving to lower age groups, the 6 - 12 - year - old group will be recruited. For every 1 to 3 participants enrolled, there will be a phased data review to guide further recruitment.
The trial has three phases: screening (D - 28~D - 1), treatment (12 - week), and follow - up (40 - week). The enrolled participants will be treated with 10 mg/kg SG301 Subcutaneous injection subcutaneously. They will receive weekly injections for the first six weeks, then every two weeks for three times, totaling nine injections.
- Conditions
- Nephrotic Syndrome in Children
- Being tested
- SG301 Subcutaneous injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SG301 Subcutaneous injectionDrug
Subcutaneous injection every weeks (QW*6),subsequently, administer it once every two weeks for a total of three times (Q2W*3). The total number of doses is nine.
| Study group | Role | What they receive |
|---|---|---|
| SG301 Subcutaneous injection | Experimental | full - dose prednisone (60 mg/m²/day, up to 80 mg) for remission induction. After 3 days of negative urine protein, start SG301 Subcutaneous injection with steroid tapering. Taper prednisolone to 60 mg/m² (max 80 mg) every other day, reducing by 1/6 every 2 weeks, and stop after 3 months. Receives: Drug: SG301 Subcutaneous injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and rate of treatment-Emergent Adverse Events
Number and percentage of adverse events which are calculated by worst CTCAE grade by CTCAE 5.0
Measured: From baseline through study completion, an average of 1 year
Relapse free survival rate
Relapse free survival rate at 6 and 12 months
Measured: Average 1 year per subject
Secondary outcomes (8)
Relapse frequency in times
Proportion of relapsed participants
Measured: From baseline through study completion, an average of 1 year
Time to Relapse
Time to first relapse after enrollment
Measured: From baseline through study completion, an average of 1 year
Serum creatinine
Serum creatinine(SCr), SCr in mg/dl
Measured: From baseline through study completion, an average of 1 year
estimated glomerular filtration rate
Estimated glomerular filtration rate (eGFR), eGFR in ml/min/1.73m²
Measured: From baseline through study completion, an average of 1 year
Cumulative corticosteroid dose
The total amount of corticosteroids used during the study period, and the total amount of corticosteroids used in the 6 months prior to enrollment
Measured: From baseline through study completion, an average of 1 year
SG301 anti-drug antibodies
Number of subjects positive for anti-SG301 anti-drug antibodies
Measured: From baseline through study completion, an average of 1 year
Neutralizing antibodies against SG301
the neutralizing antibody titer of anti-SG301 anti-drug antibodies
Measured: From baseline through study completion, an average of 1 year
pharmacokinetics : Ctrough
The trough concentration of SG301
Measured: From baseline through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start25 Aug 2025
- Primary completion9 Jul 2028 (estimated)
- Study completion9 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nephrotic Syndrome in ChildrenStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mao Jianhua
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mao Jianhua, The Children's Hospital of Zhejiang University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07087314
- Sponsor's protocol ID
- CSG-301 SC-204
- Status last verified
- Feb 2026
- First submitted
- 9 Jul 2025
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Evaluate the Initial Efficacy and Safety of Anti-CD38 Monoclonal Antibody (SG301) Subcutaneous Injection in Children With Frequent Relapses or Steroid-Dependent Nephrotic Syndrome
- ClinicalTrials.gov ID
- NCT07087314
- Acronym / sponsor ID
- CSG-301 SC-204
- Conditions
- Nephrotic Syndrome in Children
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Mao JianhuaUniversity, hospital or other
- Study start
- 25 Aug 2025 (actual)
- Primary completion
- 9 Jul 2028 (estimated)
- Study completion
- 9 Jul 2029 (estimated)
- First posted
- 25 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.
This is an open - label study to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of SG301 Subcutaneous injection in children with frequently relapsing or steroid - dependent nephrotic syndrome.
Detailed description
This study will recruit children aged 6 - 18 with frequently relapsing or steroid - dependent nephrotic syndrome, who have morning urine protein < 1 + or urine protein / creatinine < 0.2 g/g (<20 mg/mmol) for at least three consecutive days after steroid treatment.
The study will stratify participants into two age groups:≥6 - <12 years and≥12 - <18 years. Recruitment will start with the 12 - 18 - year - old group. After collecting sufficient safety and clinical pharmacology data to support moving to lower age groups, the 6 - 12 - year - old group will be recruited. For every 1 to 3 participants enrolled, there will be a phased data review to guide further recruitment.
The trial has three phases: screening (D - 28~D - 1), treatment (12 - week), and follow - up (40 - week). The enrolled participants will be treated with 10 mg/kg SG301 Subcutaneous injection subcutaneously. They will receive weekly injections for the first six weeks, then every two weeks for three times, totaling nine injections.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SG301 Subcutaneous injection | Experimental | Drug: SG301 Subcutaneous injectionfull - dose prednisone (60 mg/m²/day, up to 80 mg) for remission induction. After 3 days of negative urine protein, start SG301 Subcutaneous injection with steroid tapering. Taper prednisolone to 60 mg/m² (max 80 mg) every other day, reducing by 1/6 every 2 weeks, and stop after 3 months. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Aged 6 - 18 years.
- Steroid-sensitive nephrotic syndrome with frequent relapses (FRNS) or steroid dependence (SDNS).
- Normal renal function: eGFR≥90 ml/min/1.73m².
- After steroid treatment, morning urine protein<1 + or urine protein/creatinine<0.2 g/g (<20 mg/mmol) for ≥3 consecutive days.
- Within 7 days before enrollment, blood tests (without growth factors or transfusions) must meet: hemoglobin>80 g/L; platelets>75×10⁹/L; neutrophils>1.5×10⁹/L.
Key exclusion criteria (9 listed)
- Family history of nephrotic syndrome, chronic glomerulonephritis, or uremia.
- Alanine aminotransferase >2×ULN or total bilirubin>2×ULN with a sustained increase for 2 weeks.
- HBsAg or HBcAb positive with Hepatitis B virus DNA above the lower limit of normal; Hepatitis C virus antibody - positive with Hepatitis C virus RNA positive; HIV antibody - positive.
- Chronic active infections (e.g., Epstein-Barr Virus, Cytomegalovirus, tuberculosis) that may worsen with steroids/ immunosuppressants.
- Acute active infection (excluding onychomycosis) requiring systemic antibiotics/antivirals.
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 |
|---|---|---|
| SG301 Subcutaneous injectionSubcutaneous injection every weeks (QW*6),subsequently, administer it once every two weeks for a total of three times (Q2W*3). The total number of doses is nine. | Drug | SG301 Subcutaneous injection |
Primary outcome
Incidence and rate of treatment-Emergent Adverse Events
Time frame: From baseline through study completion, an average of 1 year
Number and percentage of adverse events which are calculated by worst CTCAE grade by CTCAE 5.0
Relapse free survival rate
Time frame: Average 1 year per subject
Relapse free survival rate at 6 and 12 months
8 secondary outcomes
Relapse frequency in times
Time frame: From baseline through study completion, an average of 1 year
Time to Relapse
Time frame: From baseline through study completion, an average of 1 year
Serum creatinine
Time frame: From baseline through study completion, an average of 1 year
estimated glomerular filtration rate
Time frame: From baseline through study completion, an average of 1 year
Cumulative corticosteroid dose
Time frame: From baseline through study completion, an average of 1 year
SG301 anti-drug antibodies
Time frame: From baseline through study completion, an average of 1 year
Neutralizing antibodies against SG301
Time frame: From baseline through study completion, an average of 1 year
pharmacokinetics : Ctrough
Time frame: From baseline through study completion, an average of 1 year
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 27 Feb 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SG301 Subcutaneous injection in people with Nephrotic Syndrome in Children, run by Mao Jianhua at 1 site in China.
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 7 inclusion and 9 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 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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. 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 Yanyan Jin, Doctor (+86 19357612502, jinyanyanzj@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and rate of treatment-Emergent Adverse Events (time frame: From baseline through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Feb 2026.