Ignite Creation Date:
2024-05-06 @ 7:45 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06125405
Status:
RECRUITING
Last Update Posted:
2023-11-09
First Post:
2023-10-24
Brief Title:
Study of the Telitacicept in Pediatric Patients With Frequently Relapsing or Steroid Dependent Nephrotic Syndrome
Sponsor:
The Childrens Hospital of Zhejiang University School of Medicine
Organization:
The Childrens Hospital of Zhejiang University School of Medicine
Study Overview
Official Title:
Study of the Telitacicept in Pediatric Patients With Frequently Relapsing or Steroid Dependent Nephrotic Syndrome
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STERN
Brief Summary:
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
Detailed Description:
Nephrotic syndromeNS 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None