V type lupus nephritis
Conditions
Interventions
Observation group (telitacept):None
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age >=18 years; 2.Meeting the ACR/EULAR SLE diagnostic criteria; 3.Patients diagnosed with type V LN by renal biopsy; 4.24-hour urine protein >1g; 5.Agree to receive Telitacicept treatment.
Exclusion criteria
Exclusion criteria: 1.Refusal to sign the Informed Consent Form (ICF); 2.Known allergy or intolerance to the investigational drug; 3.eGFR <45 mL/min/1.73 m²; 4.Concomitant neuropsychiatric SLE; 5.History of dialysis within 12 months prior to signing the ICF or anticipated need for renal replacement therapy (dialysis or kidney transplantation) within 6 months after enrollment; 6.Previous or current renal disease (excluding LN) that, in the investigator's opinion, may interfere with LN assessment and confound disease activity evaluation (e.g., diabetic nephropathy); 7.Active infections such as tuberculosis, hepatitis B, hepatitis C, etc. 8.History of cancer; 9.Known intolerance to MMF doses <=1.0 g/day; 10.Receipt of any commercially available biologic agents or immunosuppressants (other than MMF) within 1 month prior to signing the ICF;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary efficacy renal response; | — |
Secondary
| Measure | Time frame |
|---|---|
| Partial renal response;Complete Renal Response;Percentage of glucocorticoid <=7.5mg or <=5mg;Systemic Lupus Erythematosus Responder Index 4; | — |
Countries
China
Contacts
Public ContactTan Ying
Peking University First Hospital
Outcome results
None listed