active LN patients
Conditions
Interventions
Belimumab treatment group:None
Sponsors
Zhongshan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Patients to provide a signed informed consent at the time of enrollment per protocol; 2.Male or female aged 18 or over at initiation of belimumab; 3.Received belimumab for the treatment of active LN* prescribed as per local label in combination with standard immunosuppressive therapy/ies at initiation of belimumab; 4.Initiation of belimumab 6-24 months prior to study enrollment; 5.Accessibility of medical records starting at belimumab initiation (including accessibility of medical records for the prior 12 months and confirmatory biopsy within the prior 24 months from belimumab initiation); 6.Biopsy-confirmed diagnosis of active LN in the two-years prior to the initiation of belimumab:Class III (focal LN) with or without Class V (membranous LN);Class IV (diffuse LN) with or without Class V;Class V.
Exclusion criteria
Exclusion criteria: 1.Patients receiving renal replacement therapy at initiation of belimumab; 2.Patient is concomitantly receiving another biologic at initiation of belimumab; 3.Patient in a clinical trial during the observation period (with the exception of allowing patients in other non-interventional studies); 4.Patient is pregnant at the initiation of belimumab; 5.Patient with a kidney transplant at the initiation of belimumab; 6.Patients will be excluded from the study if they are planning to become pregnant or are pregnant at study enrollment;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maintaining renal function <=30% decline in eGFR and not requiring renal replacement therapy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Modified Partial Renal Response (<=20% decline eGFR and =0.7uPCR) and Modified Complete Renal Response (<=10% decline eGFR and <=0.5 uPCR); | — |
Countries
China
Contacts
Public ContactDing Xiaoqiang
Zhongshan Hospital, Fudan University
Outcome results
None listed