Assessing the effectiveness of belimumab for lupus nephritis treatment
The Evaluation Of Use of Belimumab in Routine Care SEttings in Lupus Nephritis (LN): the OBSErve-LN Study
This study is testing how well belimumab works for adults with active lupus nephritis to see if it helps protect their kidney function over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | GlaxoSmithKline Industry-sponsored |
| Drugs / interventions | belimumab |
| Locations | 5 sites (Baltimore, Maryland and 4 other locations) |
| Trial ID | NCT06527872 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the real-world effectiveness of belimumab in treating adults with active lupus nephritis (LN) across multiple countries. Participants who have been prescribed belimumab in combination with standard immunosuppressive therapies will be monitored for up to five years to assess the preservation of renal function. The study will utilize medical records to gather data on participants who initiated belimumab treatment 6 to 24 months prior to enrollment, focusing on those with a biopsy-confirmed diagnosis of active LN.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and over who have been treated with belimumab for active lupus nephritis within the specified time frame.
Not a fit: Patients receiving renal replacement therapy at the time of belimumab initiation will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term effectiveness of belimumab in preserving kidney function for patients with lupus nephritis.
How similar studies have performed: While this study focuses on real-world data, similar studies assessing the effectiveness of belimumab have shown promising results in controlled settings.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants to provide a signed informed consent at the time of enrollment per protocol, * Male or female aged 18 or over at initiation of belimumab, * Participants received belimumab in any formulation (subcutaneous or intravenous) for the treatment of active LN prescribed as per local label in combination with standard 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 (including accessibility of medical records for the prior 12 months and confirmatory biopsy at any time prior to belimumab initiation), * Biopsy-confirmed LN diagnosis at any time prior to belimumab initiation for treatment 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 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 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.
Where this trial is running
Baltimore, Maryland and 4 other locations
- GSK Investigational Site — Baltimore, Maryland, United States (Recruiting)
- GSK Investigational Site — Charlotte, North Carolina, United States (Recruiting)
- GSK Investigational Site — Columbus, Ohio, United States (Recruiting)
- GSK Investigational Site — Hixson, Tennessee, United States (Recruiting)
- GSK Investigational Site — Fukuoka, Japan (Recruiting)
Study contacts
- Study coordinator: US GSK Clinical Trials Call Center
- Email: GSKClinicalSupportHD@gsk.com
- Phone: 877-379-3718
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.