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Observational Study of Belimumab for Lupus Nephritis

This study, called OBSErve-LN, is looking at how well belimumab works in real-world settings for adults with lupus nephritis (LN), a kidney complication of lupus. Belimumab is a monoclonal antibody, a type of medicine that targets specific cells or proteins in the body. Researchers want to see if belimumab helps people maintain their kidney function over time. You might be able to join if you are 18 or older and are already receiving belimumab for active LN as prescribed by your doctor, along with other standard treatments. The study aims to follow 300 participants to see how many maintain their kidney function and don't need kidney replacement therapy after 24 months. The current recruitment status is unclear.

Study design
This is an observational, Phase 4 study that will collect data from participants both looking back at their medical history and moving forward. It aims to include 300 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed to assess kidney function at 24 months after starting belimumab, with long-term assessment up to 5 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06527872

Study to Assess Real-world Effectiveness of Belimumab for Treatment of Adults With LN

Recruiting
Not specifiedAges 18+Observational
GlaxoSmithKline
~300 participants
Updated 2026-07-02 on ClinicalTrials.gov
What's tested:None (Observational study)

At a glance

Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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
Measured over At Month 24

Conditions

Lupus Nephritis

Explore related trials

Lupus Glomerulonephritis

Where it's being run

7 sites across 7 states
Maryland1
North Carolina1
Ohio1
Tennessee1
France1
Milan1
Japan1

Study leadership

  • GSK Clinical Trials · STUDY_DIRECTOR · GlaxoSmithKline

Who to contact

US GSK Clinical Trials Call Center
[email protected]
877-379-3718
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • 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 TherapyAt Month 24

    Renal replacement therapy will involve participants requiring dialysis, kidney transplant, or those in end-stage kidney disease.