steroid-resistant nephrotic syndrome
Conditions
Interventions
Telitacicept group:Telitacicept and steroid
Tacrolimus group:Tacrolimus and steroid
Sponsors
Children's Hospital of Chongqing Medical University
Eligibility
Sex/Gender
All
Age
2 Years to 17 Years
Inclusion criteria
Inclusion criteria: 1.Inclusion criteria (those who meet all of the following conditions are included): (1) Hormone resistant nephrotic syndrome (SRNS); 2.(2) Age range: 2-17 years old; 3.(3) Glomerular filtration rate (eGFR) >= 60ml/min/1.73m2 (calculation method see Appendix 1); 4.(4) Within the first 6 months of enrollment, no use of biological agents such as rituximab, belimumab, or tacrolizumab has been made, and no use of other non biological immunosuppressive agents has been made within 3 months;
Exclusion criteria
Exclusion criteria: Exclusion criteria (excluding those who meet one of the following conditions): 1.Secondary PNS: diabetes, IgAVN, LN, etc; 2.Pathological examination of kidney tissue suggests other kidney diseases, such as IgA nephropathy, IMN, etc; 3.The baseline eGFR has been evaluated multiple times 30ml/min/1.73m2; 4. Isolation/Symptomatic Single Gene Pathogenic SRNS (mgSRNS): Co existing with other single gene genetic diseases known to affect PNS (such as WT1, NPHS2, LAMB2, PLCE1 gene mutations, etc.) (genetic screening is feasible for individuals with suspected family history or willing family members); 5. Malignant hypertension that is difficult to control with medication; 6. Merge with other kidney diseases, such as multiple renal cysts and urinary system abnormalities; 7. Congenital or acquired immunodeficiency, or concomitant active tuberculosis, active CMV EBV Patients with hepatitis B, hepatitis C, HIV infection, deep fungal infection, or other active infections;Children with severe or chronic infections, or those with a history of recurrent infections; 8.The following laboratory indicators were abnormal during enrollment: neutrophil count<1 × 10^9/L;Hemoglobin<80g/L;Platelet count<50 × 10^12/L; 11.Patients with abnormal liver function (ALT, AST exceeding 3.0 times or more of the upper limit of normal values, bilirubin exceeding 2.0 times or more of the upper limit of normal values and continuously increasing for 2 weeks); 9. Patients with tumors or severe systemic diseases such as heart, liver, blood system, endocrine system, etc; 10. Patients who are allergic to the ingredients of Taitacept; 11. Receive a live vaccine within 30 days; 12. Patients deemed unsuitable for inclusion in the trial by any researcher;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety;Urinary protein relief rate; | — |
Countries
China
Contacts
Public ContactWang Mo
Children's Hospital of Chongqing Medical University
Outcome results
None listed