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 groupSponsors and collaborators
Source ClinicalTrials.gov