The purpose of the OBSErve-LN study is to assess the real-world use and effectiveness of belimumab in routine practice for the treatment of adults with active LN in multiple countries of interest. This study aims to provide the first long-term (up to 5 years) assessment of renal function preservation in belimumab treated participants.
This is a Phase 4 study and will involve both prospective and retrospective data collection from participants.
Study Type
OBSERVATIONAL
Enrollment
300
Not Applicable since Observational Study
GSK Investigational Site
Charlotte, North Carolina, United States
RECRUITINGNumber of Participants Maintaining Renal Function (Less than Equal to [<=] 30 Percentage [%] Decline in Estimated Glomerular Filtration Rate [eGFR] from the Initiation of Belimumab) and Not Requiring Renal Replacement Therapy
Renal replacement therapy will involve participants requiring dialysis, kidney transplant, or those in end-stage kidney disease.
Time frame: At Month 24
Number of Participants Achieving Modified Partial Renal Response (<=20% Decline in eGFR and <=0.7 Urine Protein-Creatinine Ratio [uPCR]) and Modified Complete Renal Response (<=10% Decline in eGFR and <=0.5 uPCR)
Time frame: At Months 24 and 60
Number of Participants Maintaining Renal Function (<=30% Decline in eGFR from the Initiation of Belimumab) and Not Requiring Renal Replacement Therapy (in Those that Remain Adherent to Belimumab) at Month 24
Renal replacement therapy will involve participants requiring dialysis, kidney transplant, or those in end-stage kidney disease.
Time frame: At Month 24
Change in the Daily Dose of Steroid (in milligrams per day) from the Initiation of Belimumab
Time frame: Baseline (Day 1) to Month 60
Estimated Glomerular Filtration Rate (eGFR) Slope over Time
Time frame: Up to Month 60
Time to Achieving eGFR 30% and 40% Reduction
Time frame: Up to Month 60
Time to Initiating Renal Replacement Therapy
Renal replacement therapy will involve participants requiring dialysis, kidney transplant, or those in end-stage kidney disease.
Time frame: Up to Month 60
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Number of Participants Maintaining Renal Function (<=30% Decline in eGFR from the Initiation of Belimumab) and Not Requiring Renal Replacement Therapy
Renal replacement therapy will involve participants requiring dialysis, kidney transplant, or those in end-stage kidney disease.
Time frame: At Month 60