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.
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 12 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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
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.
Henan Children's Hospital Zhengzhou Children's Hospital
Zhengzhou, Henan, China
NOT_YET_RECRUITINGTongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
Wuhan, Hubei, China
NOT_YET_RECRUITINGChildren's Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
RECRUITINGIncidence and rate of treatment-Emergent Adverse Events
Number and percentage of adverse events which are calculated by worst CTCAE grade by CTCAE 5.0
Time frame: From baseline through study completion, an average of 1 year
Relapse free survival rate
Relapse free survival rate at 6 and 12 months
Time frame: Average 1 year per subject
Relapse frequency in times
Proportion of relapsed participants
Time frame: From baseline through study completion, an average of 1 year
Time to Relapse
Time to first relapse after enrollment
Time frame: From baseline through study completion, an average of 1 year
Serum creatinine
Serum creatinine(SCr), SCr in mg/dl
Time frame: 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
Time frame: 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
Time frame: From baseline through study completion, an average of 1 year
SG301 anti-drug antibodies
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Number of subjects positive for anti-SG301 anti-drug antibodies
Time frame: From baseline through study completion, an average of 1 year
Neutralizing antibodies against SG301
the neutralizing antibody titer of anti-SG301 anti-drug antibodies
Time frame: From baseline through study completion, an average of 1 year
pharmacokinetics : Ctrough
The trough concentration of SG301
Time frame: From baseline through study completion, an average of 1 year