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

STERN

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.

2023-11-24

2026-10-24

2027-10-24

Recruiting

Early phase I

20

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 20, 'type': 'ESTIMATED'}}

2023-11-09