Study of the Telitacicept in Pediatric Patients With Frequently Relapsing or Steroid Dependent Nephrotic Syndrome

Sponsor
The Children's Hospital of Zhejiang University School of Medicine
Study ID
NCT06125405
Phase
PHASE3
Status
Recruiting
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Conditions

  • Nephrotic Syndrome in Children
  • Telitacicept

Eligibility Criteria

Sex
ALL
Age
2 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Telitacicept — DRUG
    The study duration was 52 weeks, with the experimental group receiving subcutaneous injections of Telitacicept once weekly for a total of 52 weeks.

Study Details

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.

Key Dates

Start date
Nov 28, 2023
Status verified
Aug 2024
Primary completion
Oct 24, 2026
Completion
Oct 24, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

1-year relapse-free survival rate [ Time Frame: 1-year period after enrollment ]

Central Contacts

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