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

• Status: Recruiting
• Trial end date: 2027-10-24
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Children's Hospital of Zhejiang University School of Medicine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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