A Phase 3 interventional study of Telitacicept in Nephrotic Syndrome in Children and Telitacicept, sponsored by The Children's Hospital of Zhejiang University School of Medicine. Recruiting at 1 site in China. Open to participants aged 2 Years to 18 Years. Per ClinicalTrials.gov, last updated 2024-08-21.
Sponsored by The Children's Hospital of Zhejiang University School of Medicine · Phase 3, Interventional, and Treatment
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.
197 studies on the registry are indexed under Nephrotic Syndrome; 65 are open to participants now.
This study's planned enrollment of 20 is below the median of 60 across 125 interventional studies indexed under Nephrotic Syndrome.
Browse Nephrotic Syndrome studies →The Children's Hospital of Zhejiang University School of Medicine is the lead sponsor of 69 studies on the registry; 52 are open to participants now.
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Exclusion Criteria:
Weekly administration (administration time can be within 1 week + 3 days). Body weight and dosage: for subjects with body weight greater than 10kg and less than or equal to 20kg, the dose of Telitacicept is 40mg; for subjects with body weight greater than 20kg and less than or equal to 40kg, the dose of Telitacicept is 80mg; for subjects with body weight greater than 40kg and less than or equal to 60kg, the dose of Telitacicept is 120mg; for subjects with body weight greater than or equal to 60kg, the dose of Telitacicept is 160mg. Treatment duration: 52 weeks.
Drug: Telitacicept
The study duration was 52 weeks, with the experimental group receiving subcutaneous injections of Telitacicept once weekly for a total of 52 weeks.
1-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
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
Adverse event
The number of harmful reactions and the types of adverse events during the study
Time frame: 1-year period after enrollment
Plan to share: No
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Studies of the drug tested here: Telitacicept
The Children's Hospital of Zhejiang University School of Medicine