Full name

The Evaluation Of Use of Belimumab in Routine Care SEttings in Lupus Nephritis (LN): the OBSErve-LN Study

NCT Number
NCT06527872
Primary Endpoints

Primary:

  • 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:

  • 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
  • Change in the daily dose of steroid (in milligrams per day) from the initiation of belimumab. Baseline (Day 1) to Month 60
  • Estimated Glomerular Filtration Rate (eGFR) slope over time. Up to Month 60
  • Time to achieving eGFR 30% and 40% reduction. Up to Month 60
  • Time to initiating renal replacement therapy. Up 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
Order
0
Disease
LN
Menu title
OBSErve-LN: Study to Assess Real-world Effectiveness of Belimumab for Treatment of Adults With Lupus Nephritis (LN)
Version
ASN 2025
Phase
Observational
Status
Recruiting
Compound name
Belimumab
MoA
anti-BLyS mAb
Unmet Burden Fact
  • A progressive number of LN flares is associated with lower response to therapy, higher rates of progression of kidney disease, and lower patient survival
Unmet Burden Fact Reference

Perez-Arias AA, et al. Nephrol Dial Transplant. 2023 Mar 31;38(4):884-893

Study Description

The OBSErve-LN Study:  The purpose of this study is to assess the real-world use and effectiveness of belimumab in routine practice for the treatment of adults with active lupus nephritis (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.