Assessing the effectiveness of belimumab for lupus nephritis treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
  Marseille, France Recruiting
• GSK Investigational Site
  Rozzano, Milan, Italy Recruiting

Study contacts

• Study coordinator: US GSK Clinical Trials Call Center
• Email: GSKClinicalSupportHD@gsk.com
• Phone: 877-379-3718

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• LUPKYNIS in combination with belimumab, obinutuzumab, or anifrolumab for lupus nephritis

  This trial tests whether adding LUPKYNIS to other biologics (belimumab, obinutuzumab, or anifrolumab) plus a mycophenolic acid analog and a steroid can rapidly improve kidney health in adults with biopsy-proven lupus nephritis.

  Recruiting at 27 sites Phase 4 Aurinia Pharmaceuticals Inc. · La Mesa, California and 26 other locations · NCT07611214

• Combining belimumab and voclosporin for proliferative lupus kidney disease

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  Recruiting at 7 sites Phase 4 NephroNet, Inc. · Glendale, Arizona and 6 other locations · NCT07225387

• TranspoCART19 CAR-T therapy in adults with refractory lupus nephritis

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  Recruiting Phase 1/2 Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz · Badalona, Barcelona and 7 other locations · NCT07799116

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• Biomarker tests in adults with lupus to see how kidney disease changes over time

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  Recruiting Oslo University Hospital · Oslo, Oslo · NCT07666711

• Mosunetuzumab for people with systemic lupus erythematosus

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  Recruiting at 24 sites Phase 2 Hoffmann-La Roche · CABA, Buenos Aires and 23 other locations · NCT07598396

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.