Phase
Condition
Lupus Nephritis
Nephritis
Kidney Disease
Treatment
None (Observational study)
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participants to provide a signed informed consent at the time of enrollment perprotocol,
Male or female aged 18 or over at initiation of belimumab,
Participants received belimumab in any formulation (subcutaneous or intravenous) forthe treatment of active LN prescribed as per local label in combination withstandard immunosuppressive therapy/ies at initiation of belimumab,
Participants initiated belimumab 6 to 24 months prior to study enrollment,
Accessibility of medical records starting at belimumab initiation (includingaccessibility of medical records for the prior 12 months and confirmatory biopsy atany time prior to belimumab initiation),
Biopsy-confirmed LN diagnosis at any time prior to belimumab initiation fortreatment of LN
Class III (focal LN) with or without Class V (membranous LN),
Class IV (diffuse LN) with or without Class V,
Class V.
Exclusion
Exclusion Criteria:
Participants receiving renal replacement therapy (i.e., dialysis, kidney transplant,or those in end-stage kidney disease) at initiation of belimumab,
Participant is concomitantly receiving another SLE targeted monoclonal antibody (MAb), or a MAb expected to compromise immune responses, at initiation of belimumab,
Participants in a clinical trial during the observation period (with the exceptionof allowing participation in other non-interventional studies),
Participant is pregnant at the initiation of belimumab,
Participant with a kidney transplant at the initiation of belimumab,
Participants will be excluded from the study if they are planning to become pregnantor are pregnant at study enrollment.
Study Design
Study Description
Connect with a study center
GSK Investigational Site
Charlotte, North Carolina 28207
United StatesSite Not Available
GSK Investigational Site
Charlotte 4460243, North Carolina 4482348 28207
United StatesActive - Recruiting

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