Study to Assess Real-world Effectiveness of Belimumab for Treatment of Adults With LN
- Conditions
- Lupus Nephritis
- Interventions
- Other: None (Observational study)
- Registration Number
- NCT06527872
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 300
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Participants to provide a signed informed consent at the time of enrollment per protocol,
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Male or female aged 18 or over at initiation of belimumab,
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Participants received belimumab for the treatment of active LN prescribed as per local label in combination with standard immunosuppressive therapy/ies at initiation of belimumab,
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Participants initiated belimumab 6 to 24 months prior to study enrollment,
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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),
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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.
- Participants receiving renal replacement therapy at initiation of belimumab,
- Participant is concomitantly receiving another biologic at initiation of belimumab,
- Participants in a clinical trial during the observation period (with the exception of 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 pregnant or are pregnant at study enrollment.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description All Participants cohort None (Observational study) Participants with active LN who initiated belimumab as per local label alongside standard therapy/ies under routine care conditions.
- Primary Outcome Measures
Name Time Method Number 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 At Month 24
- Secondary Outcome Measures
Name Time Method Time to initiating renal replacement therapy Up to Month 60 Change in the daily dose of steroid (in milligrams per day) from the initiation of belimumab Baseline (Day 1) to Month 60 Number of participants maintaining renal function (<=30% decline in eGFR from the initiation of belimumab) and not requiring renal replacement therapy At Month 60 Number of participants achieving Modified Partial Renal Response (<=20% decline eGFR and <=0.7 Urine Protein-Creatinine Ratio [uPCR]) and Modified Complete Renal Response (<=10% decline eGFR and <=0.5 uPCR) 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 At Month 24 Estimated Glomerular Filtration Rate (eGFR) slope over time Up to Month 60 Time to achieving eGFR 30% and 40% reduction Up to Month 60
Trial Locations
- Locations (1)
GSK Investigational Site
🇺🇸Charlotte, North Carolina, United States