The main objective is to evaluate the effectiveness of telitacicept in pediatric patients with frequently relapsing or steroid dependent nephrotic syndrome within the 52-week follow-up.
Nephrotic syndrome(NS) is the most common glomerular disease in children. Approximately 45-50% of patients with nephrotic syndrome exhibit frequent relapses or are dependent on steroid therapy. Frequent relapses or steroid dependence in nephrotic syndrome have been challenging issues for clinicians. Long-term, repeated, and high-dose oral steroid use can lead to side effects such as obesity, delayed development, hypertension, diabetes, glaucoma, osteoporosis, and increased susceptibility to infections. The addition of traditional immunosuppressants such as cyclophosphamide and tacrolimus can cause severe and irreversible side effects. Therefore, exploring new drugs and their application protocols is particularly important. Telitacicept has a unique dual-target mechanism that can inhibit B cell maturation and differentiation at multiple stages, thereby inhibiting B cell activity. Clinical studies have confirmed its significant efficacy in various kidney diseases, such as lupus nephritis, IgA nephropathy, and adult recurrent minimal change nephrotic syndrome; moreover, it has good safety profiles. Therefore, through this prospective, single-center, open-label clinical trial, we aim to evaluate whether telitacicept provides superior efficacy compared to existing conventional treatment regimens for childhood frequent relapse (FR) or steroid-dependent (SD) nephrotic syndrome (NS), and assess its safety profile. Our goal is to provide an optimized treatment plan for childhood FRNS or SDNS.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
The study duration was 52 weeks, with the experimental group receiving subcutaneous injections of Telitacicept once weekly for a total of 52 weeks.
Children's Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
RECRUITING1-year relapse-free survival rate
The rate of no relapse within 1 year
Time frame: 1-year period after enrollment
Relapse of nephrotic syndrome during 12 months after enrollment
Proportion of patients with one or more relapse(s) of nephrotic syndrome
Time frame: 1-year period after enrollment
Number of relapses during 12 months follow up
Number of nephrotic syndrome relapses per patient year during the 12 months period after enrollment
Time frame: 1-year period after enrollment
The first time to relapse
The first time to relapse after patients taking part in this study
Time frame: 1-year period after enrollment
Cumulative prednisone dosage (milligrams per kilogram per year)
The total dosage of prednisones from the beginning to the end of the trial
Time frame: 1-year period after enrollment
Change in hemoglobin of the patients
The changes of hemoglobin (g/L) in each follow-up during the study
Time frame: 1-year period after enrollment
Change in blood albumin of the patients
The changes of blood albumin (g/L)in each follow-up during the study
Time frame: 1-year period after enrollment
Change in renal function of the patients
The change for renal function was judged by the changes of estimated glomerular filtration rate (eGFR in ml/min/1.73m\^2) in each follow-up during the study
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Time frame: 1-year period after enrollment
Change in mass index (BMI) during 12-month period after enrollment
Changes in standard deviation scores for weight (Wt in kilograms), height (Ht in meters) will be combined to report body mass index (BMI in kg/m\^2) during 12-month period after enrollment
Time frame: 1-year period after enrollment