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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age2-18
SponsorThe Children's Hospital of Zhejiang University School of Medicine

About this trial

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 criteria

Qualifiers

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

Disqualifiers

Family history of nephrotic syndrome, chronic glomerulonephritis or uremia

Leukopenia (White Blood Cells ≤ 3.0 * 10^9 / L)

Moderate to severe anemia (hemoglobin <9.0 g/dL)

Thrombocytopenia (platelet count <100*10^12/L)

Trial design

Treatments tested in this trial

  • Telitacicept

Treatment groups

20 Participants
are divided into 1 treatment group