Recruiting

Belimumab

Sponsor:

GlaxoSmithKline

Code:

NCT06527872

Conditions

Lupus Nephritis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

None (Observational study)

Study Details

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.

Conditions

Lupus Nephritis

Study ID

NCT06527872

Start date

Oct 4, 2024

Status verified date

Jun, 2026

Completion date

Mar 29, 2029

Anticipated

Primary completion date

Mar 29, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Arms

All Participants cohort

Participants with active LN who initiated belimumab as per local label alongside standard therapy/ies under routine care conditions.

Interventions

None (Observational study)

Not Applicable since Observational Study

Primary outcome measure

  • 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 [ Time Frame: At Month 24 ]

Central Contacts and Locations

Central contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

+44 (0) 20 89904466GSKClinicalSupportHD@gsk.com

Locations

GSK Investigational Site

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Michelle Petri

GSK Investigational Site

Recruiting

Charlotte, North Carolina, United States, 28207

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Gordon Lam

GSK Investigational Site

Recruiting

Columbus, Ohio, United States, 43201

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Isabelle Ayoub

GSK Investigational Site

Recruiting

Hixson, Tennessee, United States, 37343-7908

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com

Principal Investigator:

Joseph Huffstutter

More Information

Sponsor

GlaxoSmithKline

Last update posted

Jul 2, 2026

Last verified

Jun, 2026

Keywords

  • Belimumab
  • Lupus nephritis
  • OBSErve-LN
  • Renal function
  • Real world data

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by GlaxoSmithKline on 2026-07-02.