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

Launched by THE CHILDREN'S HOSPITAL OF ZHEJIANG UNIVERSITY SCHOOL OF MEDICINE · Nov 8, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a medication called telitacicept to see how well it works for children with a condition known as frequently relapsing or steroid-dependent nephrotic syndrome. This is a kidney problem that causes a lot of swelling and can require long-term use of steroids. The trial will follow participants for a year to determine if telitacicept can help manage their symptoms better than current treatments.

To be eligible for this trial, children aged 2 to 18 years old who have nephrotic syndrome that often comes back or requires steroids may participate. They must have normal kidney function and specific urine test results indicating manageable protein levels. However, children with certain health issues, like severe anemia, liver problems, or other serious conditions, cannot join the study. If your child is eligible and decides to participate, they will receive care and monitoring throughout the trial, helping researchers understand how effective telitacicept is for managing this challenging condition.

Gender

ALL

Eligibility 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