Study of the Telitacicept in Pediatric Patients With Frequently Relapsing or Steroid Dependent Nephrotic Syndrome
- Conditions
- TelitaciceptNephrotic Syndrome in Children
- Registration Number
- NCT06125405
- Lead Sponsor
- The Children's Hospital of Zhejiang University School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria:<br><br> - Sensitive but frequent relapses or steroids dependence nephrotic syndrome<br><br> - Age: 2 to 18 years old<br><br> - Normal renal function: estimated glomerular filtration rate =90ml/ min/1.73m2<br><br> - Morning urine protein <1+ or urine protein-creatinine ratio <0.2g/g (<20 mg/ mmol)<br> for 3 consecutive days and above when in enroll<br><br> - No rituximab was used within 6 months, no tacrolimus, mycophenolate mofetil,<br> cyclosporine A, or cyclophosphamide was used within 3 months, no ACTH was used<br> within 3 months prior to the enrollment<br><br>Exclusion Criteria:<br><br> - Family history of nephrotic syndrome, chronic glomerulonephritis or uremia<br><br> - Leukopenia (White Blood Cells = 3.0 * 10^9 / L)<br><br> - Moderate to severe anemia (hemoglobin <9.0 g/dL)<br><br> - Thrombocytopenia (platelet count <100*10^12/L)<br><br> - Positive Hepatitis B virus serological indicators (Hepatitis B surface antigen or /<br> and Hepatitis B virus e antigen or / and Hepatitis B core antibody), Hepatitis C<br> virus-positive or patients with abnormal liver function (2 or more times of alamine<br> aminotransferase or total bilirubin was exceeded the normal value, and continued to<br> rise for 2 weeks)<br><br> - There are chronic active infections such as Epstein-Barrvirus, cytomegalovirus or<br> Mycobacterium tuberculosis, and the usage of steroids and immunosuppressive agents<br> may aggravate the state of an illness<br><br> - Secondary nephrotic syndrome (such as purpuric nephritis, lupus nephritis, etc.)<br><br> - Those who with hematological or endocrine system diseases as well as serious organs<br> illness such as heart, liver or kidney<br><br> - Those who with other autoimmune diseases or primary immunodeficiencies or tumors<br><br> - Those who have participated in other clinical trials within three months prior to<br> the enrollment<br><br> - Those who was not suitable for participating this study judged by investigator
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1-year relapse-free survival rate
- Secondary Outcome Measures
Name Time Method Relapse of nephrotic syndrome during 12 months after enrollment;Number of relapses during 12 months follow up;The first time to relapse;Cumulative prednisone dosage (milligrams per kilogram per year);Change in hemoglobin of the patients;Change in blood albumin of the patients;Change in renal function of the patients;Change in mass index (BMI) during 12-month period after enrollment