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New study tracks Belimumab's Long-Term kidney benefits in lupus patients
NCT ID NCT06527872
First seen Jun 27, 2026 · Last updated Jul 02, 2026 · Updated 1 time
Summary
This study follows 300 adults with lupus nephritis who are already taking belimumab as part of their routine care. Researchers will track kidney function for up to 5 years to see how well the drug preserves renal health and prevents the need for dialysis or transplant. The goal is to understand belimumab's real-world effectiveness beyond clinical trials.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- belimumab
- What this could lead to
- If successful, this study could confirm that belimumab helps preserve kidney function in lupus nephritis patients over the long term.
- What could go wrong
- This is an observational study, not a controlled trial, so results may be influenced by other factors. It does not test a new treatment, only observes current use.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 300 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2024
- Expected to finish
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Mar 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
The study will include participants with lupus nephritis who initiated belimumab prescribed as per local label alongside standard therapy/ies under routine care conditions in the countries of interest.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
7 sites in 4 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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GSK Investigational Site
RECRUITINGHixson, Tennessee, 37343-7908, United States
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GSK Investigational Site
RECRUITINGMarseille, 13005, France
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GSK Investigational Site
RECRUITINGRozzano, Milan, 20089, Italy
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GSK Investigational Site
RECRUITINGFukuoka, 807-8556, Japan
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GSK Investigational Site
RECRUITINGBaltimore, Maryland, 21287, United States
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GSK Investigational Site
RECRUITINGCharlotte, North Carolina, 28207, United States
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GSK Investigational Site
RECRUITINGColumbus, Ohio, 43201, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- 5,000-Patient registry aims to map the Long-Term course of lupus nephritis
- Can a blood test catch lupus flares earlier?
- Can a single CAR-T infusion reset the immune system and stop lupus kidney damage?
- Blood markers may foretell kidney trouble in lupus
- Can bone marrow stem cells calm lupus kidney flares?
- Can a targeted antibody boost kidney remission in lupus?