NCT06527872 Study to Assess Real-world Effectiveness of Belimumab for Treatment of Adults With LN
| NCT ID | NCT06527872 |
| Status | Recruiting |
| Phase | — |
| Sponsor | GlaxoSmithKline |
| Condition | Lupus Nephritis |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2024-10-04 |
| Primary Completion | 2029-03-29 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2024-10-04 with a primary completion date of 2029-03-29.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of the OBSErve-LN study is to assess the real-world use and effectiveness of belimumab in routine practice for the treatment of adults with active 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.
Eligibility 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.
Contact & Investigator
GSK Clinical Trials
STUDY DIRECTOR
GlaxoSmithKline
Frequently Asked Questions
Who can join the NCT06527872 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Lupus Nephritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06527872 currently recruiting?
Yes, NCT06527872 is actively recruiting participants. Contact the research team at GSKClinicalSupportHD@gsk.com for enrollment information.
Where is the NCT06527872 trial being conducted?
This trial is being conducted at Baltimore, United States, Charlotte, United States, Columbus, United States, Hixson, United States and 3 additional locations.
Who is sponsoring the NCT06527872 clinical trial?
NCT06527872 is sponsored by GlaxoSmithKline. The principal investigator is GSK Clinical Trials at GlaxoSmithKline. The trial plans to enroll 300 participants.
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