RecruitingPhase 3NCT06125405

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

Enrollment

20 participants

Start Date

Nov 28, 2023

Study Type

INTERVENTIONAL

Conditions

Nephrotic Syndrome in Children Telitacicept

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

Min Age: 2 YearsMax Age: 18 Years

Inclusion Criteria5

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

Exclusion Criteria11

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)
Positive Hepatitis B virus serological indicators (Hepatitis B surface antigen or / and Hepatitis B virus e antigen or / and Hepatitis B core antibody), Hepatitis C virus-positive or patients with abnormal liver function (2 or more times of alamine aminotransferase or total bilirubin was exceeded the normal value, and continued to rise for 2 weeks)
There are chronic active infections such as Epstein-Barrvirus, cytomegalovirus or Mycobacterium tuberculosis, and the usage of steroids and immunosuppressive agents may aggravate the state of an illness
Secondary nephrotic syndrome (such as purpuric nephritis, lupus nephritis, etc.)
Those who with hematological or endocrine system diseases as well as serious organs illness such as heart, liver or kidney
Those who with other autoimmune diseases or primary immunodeficiencies or tumors
Those who have participated in other clinical trials within three months prior to the enrollment
Those who was not suitable for participating this study judged by investigator

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