Antibody-mediated rejection after renal transplantation
Conditions
Interventions
Control Group:Standard of Care(SOC)
Experimental Group:SOC + Telitacicept
Sponsors
The Second Affiliated Hospital of Guangxi Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Sign the informed consent; 2. Patients of both sexes aged 18-75 years after renal transplantation; 3. At least 180 days after transplantation at randomization; 4. Estimated glomerular filtration rate (eGFR) >=20 ml/min/1.73 m^2 (CKD-EPI formula); 5. Positive HLA class I and/or II antigen-specific antibodies in patients after renal transplantation; 6. Serum creatinine (sCr) <=3mg/dl; 7. Patients with active AMR according to Banff 2019 classification criteria (aAMR);
Exclusion criteria
Exclusion criteria: 1. Patients who had participated in a clinical trial of another biologic agent within the previous year; 2. Female subjects who are pregnant or lactating or do not receive adequate contraception; 3. Abo-incompatible transplantation; 4. Biopsy results: a) Banff grade >=I for T cell-mediated rejection; b) de novo or recurrent severe thrombotic microangiopathy; c) polyoma virus nephropathy (PVN); d) new onset or recurrent glomerulonephritis; 5. Received acute rejection treatment 2×ULN, alanine aminotransferase and aspartate aminotransferase >2.5×ULN; 8. Hemoglobin <8 g/dL; 9. Thrombocytopenia: platelet count <80×10^9/L; 10. Leukopenia: white blood cell <3×10^9/L; 11. Neutropenia: neutrophils <1.5×10^9/L; 12. Hypogammaglobulinemia: serum IgG<400mg/dL; 13. Active viral, bacterial or fungal infection, excluding intensive immunosuppression; 14. Active malignant disease obstructing intensive immunosuppressive therapy; 15. Latent or active tuberculosis (positive QuantiFERON tuberculosis test); 16. Vaccination with live vaccine within 6 weeks of screening; 17. History of alcohol or illicit drug abuse; 18. Serious medical or mental illness that may interfere with participation in the study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Treatment-Emergent Adverse Events (TEAEs); | — |
Secondary
| Measure | Time frame |
|---|---|
| Graft loss;C4d score;eGFR;Total score of glomerulonephritis and peritubular capillaritis;Serum Donor-Specific Antibody (DSA) Levels;Proteinuria;Peripheral Blood Leukocyte Subsets;Death;Morphological AMR Classification;Immunologic Biomarkers;Transplant glomerular disease score;Serum Immunoglobulin Levels; | — |
Countries
China
Contacts
Public ContactXuyong Sun
The Second Affiliated Hospital of Guangxi Medical University
Outcome results
None listed