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

March 24, 2026 updated by: GlaxoSmithKline

The Evaluation Of Use of Belimumab in Routine Care SEttings in Lupus Nephritis (LN): the OBSErve-LN Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a Phase 4 study and will involve both prospective and retrospective data collection from participants.

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Japan
      • Fukuoka, Japan, 807-8556
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Shingo Nakayamada
  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Michelle Petri
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Gordon Lam
    • Ohio
      • Columbus, Ohio, United States, 43201
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Isabelle Ayoub
    • Tennessee
      • Hixson, Tennessee, United States, 37343-7908
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Joseph Huffstutter

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
All Participants cohort
Participants with active LN who initiated belimumab as per local label alongside standard therapy/ies under routine care conditions.
Other: None (Observational study)
Not Applicable since Observational Study
Other Names:
  • Observational Study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Renal replacement therapy will involve participants requiring dialysis, kidney transplant, or those in end-stage kidney disease.
At Month 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Achieving Modified Partial Renal Response (<=20% Decline in eGFR and <=0.7 Urine Protein-Creatinine Ratio [uPCR]) and Modified Complete Renal Response (<=10% Decline in eGFR and <=0.5 uPCR)
Time Frame: At Months 24 and 60
At Months 24 and 60
Number of Participants Maintaining Renal Function (<=30% Decline in eGFR from the Initiation of Belimumab) and Not Requiring Renal Replacement Therapy (in Those that Remain Adherent to Belimumab) at Month 24
Time Frame: At Month 24
Renal replacement therapy will involve participants requiring dialysis, kidney transplant, or those in end-stage kidney disease.
At Month 24
Change in the Daily Dose of Steroid (in milligrams per day) from the Initiation of Belimumab
Time Frame: Baseline (Day 1) to Month 60
Baseline (Day 1) to Month 60
Estimated Glomerular Filtration Rate (eGFR) Slope over Time
Time Frame: Up to Month 60
Up to Month 60
Time to Achieving eGFR 30% and 40% Reduction
Time Frame: Up to Month 60
Up to Month 60
Time to Initiating Renal Replacement Therapy
Time Frame: Up to Month 60
Renal replacement therapy will involve participants requiring dialysis, kidney transplant, or those in end-stage kidney disease.
Up to Month 60
Number of Participants Maintaining Renal Function (<=30% Decline in eGFR from the Initiation of Belimumab) and Not Requiring Renal Replacement Therapy
Time Frame: At Month 60
Renal replacement therapy will involve participants requiring dialysis, kidney transplant, or those in end-stage kidney disease.
At Month 60

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Investigators

  • Study Director: GSK Clinical Trials, GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 4, 2024

Primary Completion (Estimated)

March 29, 2029

Study Completion (Estimated)

March 29, 2029

Study Registration Dates

First Submitted

July 26, 2024

First Submitted That Met QC Criteria

July 26, 2024

First Posted (Actual)

July 30, 2024

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 24, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 216147

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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