Study of the Telitacicept in Pediatric Patients With Frequently Relapsing or Steroid Dependent Nephrotic Syndrome
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 18
Healthy Volunteers: f
View:
• Sensitive but frequent relapses or steroids dependence nephrotic syndrome
• Age: 2 to 18 years old
• Normal renal function: estimated glomerular filtration rate ≥90ml/ min/1.73m2
• Morning urine protein \<1+ or urine protein-creatinine ratio \<0.2g/g (\<20 mg/ mmol) for 3 consecutive days and above when in enroll
• No rituximab was used within 6 months, no tacrolimus, mycophenolate mofetil, cyclosporine A, or cyclophosphamide was used within 3 months, no ACTH was used within 3 months prior to the enrollment
Locations
Other Locations
China
Children's Hospital, Zhejiang University School of Medicine
RECRUITING
Hangzhou
Contact Information
Primary
Jianhua Mao, MD
maojh88@zju.edu.cn
86057186670015
Backup
Chunyue Feng
springmoonfeng@163.com
Time Frame
Start Date: 2023-11-28
Estimated Completion Date: 2027-10-24
Participants
Target number of participants: 20
Treatments
Experimental: Telitacicept group
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.
Related Therapeutic Areas
Sponsors
Leads: The Children's Hospital of Zhejiang University School of Medicine